RESUMEN
OBJECTIVES: To evaluate the 1-year cost-effectiveness of strength exercise or aerobic exercise compared with usual care for patients with symptomatic knee osteoarthritis (OA), from a societal and healthcare perspective. DESIGN: Cost-effectiveness analysis embedded in a three-arm randomised controlled trial. PARTICIPANTS AND SETTING: A total of 161 people with symptomatic knee OA seeking Norwegian primary or secondary care were included in the analyses. INTERVENTIONS: Participants were randomised to either 12 weeks of strength exercise (n=54), 12 weeks of aerobic exercise (n=53) or usual care (n=54). OUTCOME MEASURES: Quality-adjusted life-years (QALYs) estimated by the EuroQol-5 Dimensions-5 Levels, and costs related to healthcare utilisation and productivity loss estimated in euros (), aggregated for 1 year of follow-up. Cost-effectiveness was expressed with mean incremental cost-effectiveness ratios (ICERs). Bootstrapping was used to estimate ICER uncertainty. RESULTS: From a 1-year societal perspective, the mean cost per patient was 7954, 8101 and 17 398 in the strength exercise, aerobic exercise and usual care group, respectively. From a 1-year healthcare perspective, the mean cost per patient was 848, 2003 and 1654 in the strength exercise, aerobic exercise and usual care group, respectively. Mean differences in costs significantly favoured strength exercise and aerobic exercise from a 1-year societal perspective and strength exercise from a 1-year healthcare perspective. There were no significant differences in mean QALYs between groups. From a 1-year societal perspective, at a willingness-to-pay threshold of 27 500, the probability of strength exercise or aerobic exercise being cost-effective was ≥98%. From a 1-year healthcare perspective, the probability of strength exercise or aerobic exercise being cost-effective was ≥97% and ≥76%, respectively. CONCLUSION: From a 1-year societal and healthcare perspective, a 12-week strength exercise or aerobic exercise programme is cost-effective compared with usual care in patients with symptomatic knee OA. TRIAL REGISTRATION NUMBER: NCT01682980.
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Análisis Costo-Beneficio , Terapia por Ejercicio , Osteoartritis de la Rodilla , Años de Vida Ajustados por Calidad de Vida , Entrenamiento de Fuerza , Humanos , Osteoartritis de la Rodilla/terapia , Osteoartritis de la Rodilla/economía , Masculino , Femenino , Noruega , Persona de Mediana Edad , Anciano , Terapia por Ejercicio/economía , Terapia por Ejercicio/métodos , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/métodos , Ejercicio Físico , Costos de la Atención en Salud/estadística & datos numéricosRESUMEN
OBJECTIVES: Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, "nonstratified" exercise therapy. METHODS: A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a "high muscle strength subgroup," "low muscle strength subgroup," or "obesity subgroup" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed. CONCLUSION: This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.
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Terapia por Ejercicio/economía , Osteoartritis de la Rodilla/economía , Osteoartritis de la Rodilla/terapia , Dimensión del Dolor/economía , Análisis Costo-Beneficio , Terapia por Ejercicio/métodos , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Manipulaciones Musculoesqueléticas/economía , Dimensión del Dolor/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/economía , Entrenamiento de Fuerza/economía , Resultado del TratamientoRESUMEN
BACKGROUND: Exercise training is a promising approach for managing multiple sclerosis (MS), but existing research has not focused on black individuals with MS. This is important as black individuals with MS may experience a more aggressive disease course, increased comorbidities, and have a poorer prognosis with disease modifying therapies. MATERIALS AND METHODS: Thirty-two black adults with mild-to-moderate MS related disability participated in a patient-informed, three-month, home-based, racially tailored, exercise program. The exercise program, Project GEMS, was modified for black persons with MS through patient feedback. The feasibility of the modified exercise program was measured through the four domains of process (e.g., recruitment and retention), resources (e.g., communication and monetary costs), management (e.g., of data management and safety reporting), and scientific outcomes (e.g., safety, burden, adherence, experience, and treatment effect). RESULTS: This exercise program was feasible, safe, and well received based on data analysis and formative evaluation. Twenty-four participants completed post-assessment (75%; two dropped out, six did not return follow-up assessments). The exercise program cost a total of $3726.57 (personnel costsâ¯=â¯$2128.74 USD, $20.87 USD per/h; exercise program costsâ¯=â¯$1597.83 USD, mean cost per personâ¯=â¯$46.93). Participants were adherent with 70% of the 48 exercise sessions via self-reported exercise logs. There was a significant and large increase (tâ¯=â¯-5.1, pâ¯<â¯.001, dâ¯=â¯-1.0) in exercise behavior as measured by the Godin Leisure-Time Exercise Questionnaire. CONCLUSION: The results support the feasibility, acceptability, safety, and efficacy of this intervention for increasing exercise behavior among black adults with mild-to-moderate MS.
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Negro o Afroamericano , Terapia por Ejercicio/métodos , Esclerosis Múltiple/rehabilitación , Cooperación del Paciente , Adulto , Costos y Análisis de Costo , Terapia por Ejercicio/economía , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Aceptación de la Atención de Salud , Selección de Paciente , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/métodos , Autocuidado , Resultado del TratamientoRESUMEN
PURPOSE: This study aimed to evaluate the long-term effectiveness and cost-effectiveness of high intensity (HI) versus low-to-moderate intensity (LMI) exercise on physical fitness, fatigue, and health-related quality of life (HRQoL) in cancer survivors. METHODS: Two hundred seventy-seven cancer survivors participated in the Resistance and Endurance exercise After ChemoTherapy (REACT) study and were randomized to 12 weeks of HI (n = 139) or LMI exercise (n = 138) that had similar exercise types, durations, and frequencies, but different intensities. Measurements were performed at baseline (4-6 weeks after primary treatment), and 12 (i.e., short term) and 64 (i.e., longer term) weeks later. Outcomes included cardiorespiratory fitness, muscle strength, self-reported fatigue, HRQoL, quality-adjusted life years (QALYs) and societal costs. Linear mixed models were conducted to study (a) differences in effects between HI and LMI exercise at longer term, (b) within-group changes from short term to longer term, and (c) the cost-effectiveness from a societal perspective. RESULTS: At longer term, intervention effects on role (ß = 5.9, 95% CI = 0.5; 11.3) and social functioning (ß = 5.7, 95%CI = 1.7; 9.6) were larger for HI compared to those for LMI exercise. No significant between-group differences were found for physical fitness and fatigue. Intervention-induced improvements in cardiorespiratory fitness and HRQoL were maintained between weeks 12 and 64, but not for fatigue. From a societal perspective, the probability that HI was cost-effective compared to LMI exercise was 0.91 at 20,000/QALY and 0.95 at 52,000/QALY gained, mostly due to significant lower healthcare costs in HI exrcise. CONCLUSIONS: At longer term, we found larger intervention effects on role and social functioning for HI than for LMI exercise. Furthermore, HI exercise was cost-effective with regard to QALYs compared to LMI exercise. TRIAL REGISTRATION: This study is registered at the Netherlands Trial Register [NTR2153 [ http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2153 ]] on the 5th of January 2010. IMPLICATIONS FOR CANCER SURVIVORS: Exercise is recommended to be part of standard cancer care, and HI may be preferred over LMI exercise.
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Supervivientes de Cáncer , Entrenamiento Aeróbico , Terapia por Ejercicio , Entrenamiento de Fuerza , Adulto , Supervivientes de Cáncer/estadística & datos numéricos , Capacidad Cardiovascular , Análisis Costo-Beneficio , Entrenamiento Aeróbico/economía , Entrenamiento Aeróbico/métodos , Terapia por Ejercicio/economía , Terapia por Ejercicio/métodos , Fatiga , Femenino , Costos de la Atención en Salud , Humanos , Masculino , Persona de Mediana Edad , Fuerza Muscular , Países Bajos/epidemiología , Aptitud Física/fisiología , Calidad de Vida , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/métodos , Resultado del TratamientoRESUMEN
OBJECTIVE: To determine the impact of long-term, body weight-supported locomotor training after chronic, incomplete spinal cord injury (SCI), and to estimate the health care costs related to lost recovery potential and preventable secondary complications that may have occurred because of visit limits imposed by insurers. DESIGN: Prospective observational cohort with longitudinal follow-up. SETTING: Eight outpatient rehabilitation centers that participate in the Christopher & Dana Reeve Foundation NeuroRecovery Network (NRN). PARTICIPANTS: Individuals with motor incomplete chronic SCI (American Spinal Injury Association Impairment Scale C or D; N=69; 0.1-45y after SCI) who completed at least 120 NRN physical therapy sessions. INTERVENTIONS: Manually assisted locomotor training (LT) in a body weight-supported treadmill environment, overground standing and stepping activities, and community integration tasks. MAIN OUTCOME MEASURES: International Standards for Neurological Classification of Spinal Cord Injury motor and sensory scores, orthostatic hypotension, bowel/bladder/sexual function, Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI), Berg Balance Scale, Modified Functional Reach, 10-m walk test, and 6-minute walk test. Longitudinal outcome measure collection occurred every 20 treatments and at 6- to 12-month follow-up after discharge from therapy. RESULTS: Significant improvement occurred for upper and lower motor strength, functional activities, psychological arousal, sensation of bowel movement, and SCI-FAI community ambulation. Extended training enabled minimal detectable changes at 60, 80, 100, and 120 sessions. After detectable change occurred, it was sustained through 120 sessions and continued 6 to 12 months after treatment. CONCLUSIONS: Delivering at least 120 sessions of LT improves recovery from incomplete chronic SCI. Because walking reduces rehospitalization, LT delivered beyond the average 20-session insurance limit can reduce rehospitalizations and long-term health costs.
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Costos de la Atención en Salud/estadística & datos numéricos , Modalidades de Fisioterapia/economía , Entrenamiento de Fuerza/economía , Traumatismos de la Médula Espinal/rehabilitación , Adulto , Femenino , Estudios de Seguimiento , Humanos , Seguro de Salud , Locomoción , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recuperación de la Función , Centros de Rehabilitación , Entrenamiento de Fuerza/métodos , Traumatismos de la Médula Espinal/economía , Traumatismos de la Médula Espinal/fisiopatología , Resultado del Tratamiento , Prueba de PasoRESUMEN
OBJECTIVE: The objective of this study was to provide an overview of evidence regarding exercise therapies for patients with lower extremity peripheral artery disease (PAD). METHODS: This manuscript summarizes the content of a lecture delivered as part of the 2016 Crawford Critical Issues Symposium. RESULTS: Multiple randomized clinical trials demonstrate that supervised treadmill exercise significantly improves treadmill walking performance in people with PAD and intermittent claudication symptoms. A meta-analysis of 25 randomized trials demonstrated a 180-meter increase in treadmill walking distance in response to supervised exercise interventions compared with a nonexercising control group. Supervised treadmill exercise has been inaccessible to many patients with PAD because of lack of medical insurance coverage. However, in 2017, the Centers for Medicare and Medicaid Services issued a decision memorandum to support health insurance coverage of 12 weeks of supervised treadmill exercise for patients with walking impairment due to PAD. Recent evidence also supports home-based walking exercise to improve walking performance in people with PAD. Effective home-exercise programs incorporate behavioral change interventions such as a remote coach, goal setting, and self-monitoring. Supervised treadmill exercise programs preferentially improve treadmill walking performance, whereas home-based walking exercise programs preferentially improve corridor walking, such as the 6-minute walk test. Clinical trial evidence also supports arm or leg ergometry exercise to improve walking endurance in people with PAD. Treadmill walking exercise appears superior to resistance training alone for improving walking endurance. CONCLUSIONS: Supervised treadmill exercise significantly improves treadmill walking performance in people with PAD by approximately 180 meters compared with no exercise. Recent evidence suggests that home-based exercise is also effective and preferentially improves over-ground walking performance, such as the 6-minute walk test.
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Terapia por Ejercicio/métodos , Tolerancia al Ejercicio , Servicios de Atención de Salud a Domicilio , Claudicación Intermitente/terapia , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/terapia , Entrenamiento de Fuerza , Caminata , Medicina Basada en la Evidencia , Terapia por Ejercicio/economía , Costos de la Atención en Salud , Servicios de Atención de Salud a Domicilio/economía , Humanos , Cobertura del Seguro , Claudicación Intermitente/diagnóstico , Claudicación Intermitente/economía , Claudicación Intermitente/fisiopatología , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/economía , Enfermedad Arterial Periférica/fisiopatología , Ensayos Clínicos Controlados Aleatorios como Asunto , Recuperación de la Función , Entrenamiento de Fuerza/economía , Resultado del Tratamiento , Prueba de PasoRESUMEN
Progressive resistance plus balance training (PRBT) has been demonstrated as effective in reducing later life physical disability, falls risk and poor health, even among those with complex health care needs. However, few studies have examined the influence of PRBT on health service utilisation, cognitive wellbeing and training modality acceptance or undertaken a cost benefit analysis. This project will investigate the broad scope benefits of PRBT participation among community-dwelling older Australians receiving Government supported aged care packages for their complex health care needs. Using a modified stepped-wedge design, 248 community-dwelling adults 65 years and older with some level of government support aged care have been randomised into the study. Those randomised to exercise undertake six months of twice weekly machine-based, moderate to high intensity, supervised PRBT, followed by a six month unsupervised, unsupported follow-up. Controls spend six months undertaking usual activities, before entering the PRBT and follow-up phases. Data are collected at baseline and after each of the six month phases. Measures include level of and change in health and care needs, body composition, muscle capacity, falls, sleep, quality of life, nutritional and mental health status. In addition, acceptance and engagement is determined through telephone and focus group interviews complementing a multi-model health cost benefit evaluation. It is hypothesised this study will demonstrate the feasibility and efficacy of PRBT in improving primary and secondary health outcomes for older adults with aged care needs, and will support the value of this modality of exercise as an integral evidence-based service model of care.
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Accidentes por Caídas/prevención & control , Promoción de la Salud/métodos , Servicios de Salud para Ancianos , Equilibrio Postural , Entrenamiento de Fuerza/métodos , Anciano , Anciano de 80 o más Años , Australia , Protocolos Clínicos , Análisis Costo-Beneficio , Femenino , Estudios de Seguimiento , Promoción de la Salud/economía , Humanos , Vida Independiente , Masculino , Calidad de Vida , Entrenamiento de Fuerza/economíaAsunto(s)
Diabetes Mellitus/terapia , Ejercicio Físico , Centros de Acondicionamiento , Conductas Relacionadas con la Salud , Entrenamiento de Fuerza , Biomarcadores/sangre , Glucemia/metabolismo , Diabetes Mellitus/sangre , Diabetes Mellitus/economía , Diabetes Mellitus/fisiopatología , Diabetes Mellitus/psicología , Ejercicio Físico/psicología , Honorarios y Precios , Centros de Acondicionamiento/economía , Costos de la Atención en Salud , Gastos en Salud , Conocimientos, Actitudes y Práctica en Salud , Humanos , Motivación , Aptitud Física , Entrenamiento de Fuerza/economía , Factores de TiempoRESUMEN
INTRODUCTION: Exercise is effective in reducing falls in people with Parkinson disease. However, information on the cost effectiveness of this approach is lacking. We conducted a cost-effectiveness analysis of Tai Ji Quan for reducing falls among patients with mild-to-moderate Parkinson disease. METHODS: We used data from a previous intervention trial to analyze resource use costs related to intervention delivery and number of falls observed during a 9-month study period. Cost effectiveness was estimated via incremental cost-effectiveness ratio (ICER) in which Tai Ji Quan was compared with 2 alternative interventions (Resistance training and Stretching) on the primary outcome of per fall prevented and the secondary outcome of per participant quality-adjusted life years (QALY) gained. We also conducted subgroup and sensitivity analyses. RESULTS: Tai Ji Quan was more effective than either Resistance training or Stretching; it had the lowest cost and was the most effective in improving primary and secondary outcomes. Compared with Stretching, Tai Ji Quan cost an average of $175 less for each additional fall prevented and produced a substantial improvement in QALY gained at a lower cost. Results from subgroup and sensitivity analyses showed no variation in cost-effectiveness estimates. However, sensitivity analyses demonstrated a much lower ICER ($27) when only intervention costs were considered. CONCLUSION: Tai Ji Quan represents a cost-effective strategy for optimizing spending to prevent falls and maximize health gains in people with Parkinson disease. While these results are promising, they warrant further validation.
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Accidentes por Caídas/prevención & control , Análisis Costo-Beneficio , Promoción de la Salud/economía , Enfermedad de Parkinson/complicaciones , Años de Vida Ajustados por Calidad de Vida , Taichi Chuan/economía , Accidentes por Caídas/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Servicios de Salud Comunitaria , Estudios de Seguimiento , Promoción de la Salud/métodos , Estado de Salud , Humanos , Persona de Mediana Edad , Ejercicios de Estiramiento Muscular/economía , Ejercicios de Estiramiento Muscular/métodos , Oregon/epidemiología , Enfermedad de Parkinson/patología , Enfermedad de Parkinson/terapia , Aceptación de la Atención de Salud , Equilibrio Postural/fisiología , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/métodos , Autoinforme , Sensibilidad y Especificidad , Encuestas y Cuestionarios , Taichi Chuan/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Diabetes, a highly prevalent, chronic disease, is associated with increasing frailty and functional decline in older people, with concomitant personal, social, and public health implications. We describe the rationale and methods of the multi-modal intervention in diabetes in frailty (MID-Frail) study. METHODS/DESIGN: The MID-Frail study is an open, randomised, multicentre study, with random allocation by clusters (each trial site) to a usual care group or an intervention group. A total of 1,718 subjects will be randomised with each site enrolling on average 14 or 15 subjects. The primary objective of the study is to evaluate, in comparison with usual clinical practice, the effectiveness of a multi-modal intervention (specific clinical targets, education, diet, and resistance training exercise) in frail and pre-frail subjects aged ≥70 years with type 2 diabetes in terms of the difference in function 2 years post-randomisation. Difference in function will be measured by changes in a summary ordinal score on the short physical performance battery (SPPB) of at least one point. Secondary outcomes include daily activities, economic evaluation, and quality of life. DISCUSSION: The MID-Frail study will provide evidence on the clinical, functional, social, and economic impact of a multi-modal approach in frail and pre-frail older people with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01654341.
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Diabetes Mellitus Tipo 2/terapia , Dieta , Conocimientos, Actitudes y Práctica en Salud , Educación del Paciente como Asunto , Proyectos de Investigación , Entrenamiento de Fuerza , Actividades Cotidianas , Factores de Edad , Anciano , Protocolos Clínicos , Terapia Combinada , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/economía , Dieta/efectos adversos , Dieta/economía , Europa (Continente) , Anciano Frágil , Costos de la Atención en Salud , Humanos , Educación del Paciente como Asunto/economía , Calidad de Vida , Entrenamiento de Fuerza/economía , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The primary aims of this hybrid Type 1 effectiveness-implementation trial were to quantitatively assess whether an evidence-based exercise intervention for breast cancer survivors, Strength After Breast Cancer, was safe and effective in a new setting and to qualitatively assess barriers to implementation. METHODS: A cohort of 84 survivors completed measurements related to limb volume, muscle strength, and body image at baseline, 67 survivors completed measurements 12 months later. Qualitative methods were used to understand barriers to implementation experienced by referring oncology clinicians and physical therapists who delivered the program. RESULTS: Similar to the efficacy trial, the revised intervention demonstrated safety with regard to lymphedema, and led to improvements in lymphedema symptoms, muscular strength, and body image. Comparison of effects in the effectiveness trial to effects in the efficacy trial revealed larger strength increases in the efficacy trial than in the effectiveness trial (P < .04), but few other differences were found. Qualitative implementation data suggested significant barriers around intervention characteristics, payment, eligibility criteria, the referral process, the need for champions (ie, advocates), and the need to adapt during implementation of the intervention, which should be considered in future dissemination and implementation efforts. CONCLUSIONS: This trial successfully demonstrated that a physical therapy led strength training program for breast cancer survivors can be implemented in a community setting while retaining the effectiveness and safety of the clinical trial. However, during the translation process, strategies to reduce barriers to implementation are required. This new program can inform larger scale dissemination and implementation efforts.
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Actitud del Personal de Salud , Neoplasias de la Mama/rehabilitación , Medicina Integrativa/organización & administración , Linfedema/terapia , Entrenamiento de Fuerza , Sobrevivientes/psicología , Adulto , Anciano , Imagen Corporal , Neoplasias de la Mama/fisiopatología , Neoplasias de la Mama/psicología , Medicina Basada en la Evidencia , Ejercicio Físico/fisiología , Ejercicio Físico/psicología , Femenino , Humanos , Medicina Integrativa/economía , Persona de Mediana Edad , Fuerza Muscular , Músculo Esquelético/fisiología , Selección de Paciente , Desarrollo de Programa , Evaluación de Programas y Proyectos de Salud , Derivación y Consulta , Entrenamiento de Fuerza/efectos adversos , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/organización & administraciónRESUMEN
OBJECTIVE: To compare the injury-related societal costs of an injury prevention program with usual warm up programs for amateur adult male soccer players. DESIGN: Cost effectiveness analysis of a cluster-randomized controlled trial. SETTING: Regional amateur male soccer competitions in the Netherlands during the 2009 season. Cost estimates in the Netherlands are made in 2009 Euros (&OV0556;1.00â¼US$1.43 in late 2009). PARTICIPANTS: Soccer teams from 2 first-class competitions (the second-highest Dutch amateur level) were approached. Male players aged between 18 and 40 years, who were part of the first team at the start of the season, were eligible for inclusion. Twenty-three teams including 479 players were randomized and 456 (95%) were included in the analysis. INTERVENTION: The injury prevention program was The11, which includes 10 structured exercises developed by the FIFA Medical and Research Centre. The exercises, led by trained coaches, were designed to improve the stability, strength, co-ordination, and flexibility of the trunk, hip, and leg muscles and were performed 2 or 3 times per week as warm-up sessions. Compliance with the exercises was monitored randomly by the researchers. The control teams continued their usual warm-up routines. During the season, individual participants' exposure to training sessions or matches (in minutes) was reported weekly by the coaches. All participants completed questionnaires that included playing and injury history and current occupation and hours worked. Employment (vs studying) was nonsignificantly more common in the control group than the intervention group (68% vs 56%). MAIN COST AND OUTCOME MEASURES: Costs included those of the intervention, direct healthcare costs of injury, and indirect costs such as hours of work lost, which were recorded on a recovery form. Injuries occurring during the competition season were recorded weekly by the paramedical staff of the team. An injury was defined as a physical complaint sustained by a participant that resulted from a soccer training session or soccer match, whether or not there was lost time from soccer or need for medical attention. Full recovery was defined as participation throughout a training or match session. MAIN RESULTS: The players' injury rates were almost identical in the intervention and control groups (0.93 vs 0.94, representing 60.5% and 59.7% of players). The mean cost of The11, per player, was &OV0556;14 for the intervention group and &OV0556;0 for the control group. Direct healthcare costs per player were not significantly lower in the intervention group (difference, &OV0556;-44; 95% confidence interval [CI], -17 to 111). Indirect costs were lower in the intervention group (difference, &OV0556;-172; 95% CI, -352 to -28). The total cost per player was also lower in The11 group (difference, &OV0556;-201; 95% CI, -426 to -15). Direct health care costs per injured player were not significantly lower in the intervention group (difference, &OV0556;-76; 95% CI, -285 to 18). Indirect costs were lower in The11 group (difference, &OV0556;-288; 95% CI, -589 to -49). The total per injured player was, therefore, lower in The11 group (difference, &OV0556;-350; 95% CI, -733 to -51). CONCLUSIONS: The injury prevention strategy, The11, did not lower the rate of injuries in adult male soccer players, but the costs per player and per injured player were lower in the intervention group.
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Traumatismos en Atletas/economía , Traumatismos en Atletas/prevención & control , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/métodos , Fútbol/lesiones , Humanos , MasculinoRESUMEN
BACKGROUND: Despite an extensive literature on treatment interventions for patients with knee osteoarthritis, studies comparing the efficacy of different exercise interventions and living the life as usual on quality of life, cartilage quality and cost-effectiveness are lacking. The aim of the present study is to compare the efficacy of two different exercise programs compared to a control group in individuals with established radiographic and symptomatic knee osteoarthritis on self-reported knee-related quality of life, knee pain, physical function, and cartilage quality. METHODS/DESIGN: A three-armed randomized controlled trial involving two exercise interventions and a control group of individuals doing as they usually do is described. The patients will have mild to moderate radiographic osteoarthritis according to the Kellgren and Lawrence classification (grade 2-3), and fulfill the American College of Rheumatology clinical criteria, be aged between 45 and 65 years, and have no other serious physical or mental illnesses. The patients will be randomly allocated to a strength exercise group; a cycling group, or a control group. The primary outcome is the Knee injury and Osteoarthritis Outcome Score knee-related quality of life subscale. Secondary outcomes include all five Knee Injury and Osteoarthritis Outcome Score subscales, morphological evaluation of cartilage including focal thickness, subchondral bone marrow edema, proteoglycan content and collagen degradation (measured using magnetic resonance imaging clinical sequences, T2 mapping and T1ρ), specific serum biomarkers, isokinetic muscle strength, maximal oxygen uptake, quality of life (EuroQol 5D), and self-efficacy (Arthritis Self-Efficacy Scale). A sample size calculation on the primary outcome showed that 207 individuals, 69 in each group, is needed to detect a clinically relevant difference of 10 points with 80% power and a significance level of 5%. Assessments will be conducted at baseline, 14 weeks, 1 year and 2 years post-randomization. The interventions will be a 14 weeks exercise program. DISCUSSION: Although exercise therapy has been found to be effective in knee osteoarthritis, the knowledge of the underlying mechanisms for why exercise works is lacking. This study will contribute with knowledge on the efficacy of strength exercise versus cycling on patient-reported outcomes, cartilage quality and cost-effectiveness. TRIAL REGISTRATION: Clinicaltrial.gov Identifier: NCT01682980.
Asunto(s)
Ciclismo , Terapia por Ejercicio/métodos , Articulación de la Rodilla/fisiopatología , Osteoartritis de la Rodilla/terapia , Proyectos de Investigación , Entrenamiento de Fuerza , Anciano , Artralgia/diagnóstico , Artralgia/etiología , Artralgia/fisiopatología , Artralgia/terapia , Ciclismo/economía , Fenómenos Biomecánicos , Cartílago Articular/diagnóstico por imagen , Cartílago Articular/fisiopatología , Análisis Costo-Beneficio , Terapia por Ejercicio/economía , Femenino , Costos de la Atención en Salud , Humanos , Articulación de la Rodilla/diagnóstico por imagen , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Noruega , Osteoartritis de la Rodilla/complicaciones , Osteoartritis de la Rodilla/diagnóstico , Osteoartritis de la Rodilla/economía , Osteoartritis de la Rodilla/fisiopatología , Dimensión del Dolor , Calidad de Vida , Radiografía , Entrenamiento de Fuerza/economía , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Mild cognitive impairment (MCI) represents a critical window to intervene against dementia. Exercise training is a promising intervention strategy, but the efficiency (i.e., relationship of costs and consequences) of such types of training remains unknown. Thus, we estimated the incremental cost-effectiveness of resistance training or aerobic training compared with balance and tone exercises in terms of changes in executive cognitive function among senior women with probable MCI. METHODS: Economic evaluation conducted concurrently with a six-month three arm randomized controlled trial including eighty-six community dwelling women aged 70 to 80 years living in Vancouver, Canada. Participants received twice-weekly resistance training (nâ=â28), twice weekly aerobic training (nâ=â30) or twice-weekly balance and tone (control group) classes (nâ=â28) for 6 months. The primary outcome measure of the Exercise for Cognition and Everyday Living (EXCEL) study assessed executive cognitive function, a test of selective attention and conflict resolution (i.e., Stroop Test). We collected healthcare resource utilization costs over six months. RESULTS: Based on the bootstrapped estimates from our base case analysis, we found that both the aerobic training and resistance training interventions were less costly than twice weekly balance and tone classes. Compared with the balance and tone group, the resistance-training group had significantly improved performance on the Stroop Test (pâ=â0.04). CONCLUSIONS: Resistance training and aerobic training result in health care cost saving and are more effective than balance and tone classes after only 6 months of intervention. Resistance training is a promising strategy to alter the trajectory of cognitive decline in seniors with MCI. TRIAL REGISTRATION: ClinicalTrials.gov NCT00958867.
Asunto(s)
Disfunción Cognitiva/economía , Disfunción Cognitiva/terapia , Ejercicio Físico , Equilibrio Postural , Entrenamiento de Fuerza/economía , Anciano , Anciano de 80 o más Años , Disfunción Cognitiva/fisiopatología , Análisis Costo-Beneficio , Femenino , Costos de la Atención en Salud/estadística & datos numéricos , Humanos , Cooperación del Paciente/estadística & datos numéricos , Características de la Residencia/estadística & datos numéricos , Resultado del TratamientoRESUMEN
QUESTION: Is an injury prevention program consisting of 10 exercises designed to improve stability, muscle strength, co-ordination, and flexibility of the trunk, hip and leg muscles (known as The11) cost effective in adult male amateur soccer players? DESIGN: Cost-effectiveness analysis of a cluster-randomised controlled trial. PARTICIPANTS: 479 adult male amateur soccer players aged 18-40 years. INTERVENTION: The intervention group was instructed to perform the exercises at each training session (2 to 3 sessions per week) during one soccer season. The exercises focus on core stability, eccentric training of thigh muscles, proprioceptive training, dynamic stabilisation, and plyometrics with straight leg alignment. The control group continued their usual warm-up. OUTCOME MEASURES: All injuries and costs associated with these injuries were compared between groups after bootstrapping (5000 replications). RESULTS: No significant differences in the proportion of injured players and injury rate were found between the two groups. Mean overall costs in the intervention group were 161 (SD 447) per athlete and 256 (SD 555) per injured athlete. Mean overall costs in the control group were 361 (SD 1529) per athlete and 606 (SD 1944) per injured athlete. Statistically significant cost differences in favour of the intervention group were found per player (mean difference 201, 95% CI 15 to 426) and per injured player (mean difference 350, 95% CI 51 to 733). CONCLUSIONS: The exercises failed to significantly reduce the number of injuries in male amateur soccer players within one season, but did significantly reduce injury-related costs. The cost savings might be the result of a preventive effect on knee injuries, which often have substantial costs due to lengthy rehabilitation and lost productivity. TRIAL REGISTRATION: NTR2416.
Asunto(s)
Traumatismos en Atletas/economía , Traumatismos en Atletas/prevención & control , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/métodos , Fútbol/lesiones , Adolescente , Adulto , Traumatismos en Atletas/fisiopatología , Análisis Costo-Beneficio/estadística & datos numéricos , Humanos , Masculino , Evaluación de Resultado en la Atención de Salud , Modalidades de Fisioterapia/economía , Músculo Cuádriceps/fisiología , Fútbol/fisiología , Muslo/fisiología , Adulto JovenRESUMEN
BACKGROUND: The age- and gender-specific incidence of total hip replacement surgery has increased over the last two decades in all age groups. Recent studies indicate that non-surgical interventions are effective in reducing pain and disability, even at later stages of the disease when joint replacement is considered. We hypothesize that the time to hip replacement can be postponed in patients with severe hip osteoarthritis following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone. METHODS/DESIGN: A prospective, blinded, parallel-group multi-center trial (2 sites), with balanced randomization [1:1]. Patients with hip osteoarthritis and an indication for hip replacement surgery, aged 40 years and above, will be consecutively recruited and randomized into two treatment groups. The active treatment group will receive 3 months of supervised exercise consisting of 12 sessions of individualized, goal-based neuromuscular training, and 12 sessions of intensive resistance training plus patient education (3 sessions). The control group will receive only patient education (3 sessions). The primary end-point for assessing the effectiveness of the intervention is 12 months after baseline. However, follow-ups will also be performed once a year for at least 5 years. The primary outcome measure is the time to hip replacement surgery measured on a Kaplain-Meier survival curve from time of inclusion. Secondary outcome measures are the five subscales of the Hip disability and Osteoarthritis Outcome Score, physical activity level (UCLA activity score), and patient's global perceived effect. Other measures include pain after exercise, joint-specific adverse events, exercise adherence, general health status (EQ-5D-5L), mechanical muscle strength and performance in physical tests. A cost-effectiveness analysis will also be performed. DISCUSSION: To our knowledge, this is the first randomized clinical trial comparing a patient education plus supervised exercise program to patient education alone in hip osteoarthritis patients with an indication for surgery on the time to total hip replacement. TRIAL REGISTRATION: NCT01697241.
Asunto(s)
Artroplastia de Reemplazo de Cadera , Conocimientos, Actitudes y Práctica en Salud , Articulación de la Cadera/cirugía , Osteoartritis de la Cadera/terapia , Educación del Paciente como Asunto , Proyectos de Investigación , Entrenamiento de Fuerza , Tiempo de Tratamiento , Adulto , Artroplastia de Reemplazo de Cadera/economía , Fenómenos Biomecánicos , Terapia Combinada , Análisis Costo-Beneficio , Dinamarca , Evaluación de la Discapacidad , Costos de la Atención en Salud , Articulación de la Cadera/fisiopatología , Humanos , Estimación de Kaplan-Meier , Fuerza Muscular , Osteoartritis de la Cadera/diagnóstico , Osteoartritis de la Cadera/economía , Osteoartritis de la Cadera/fisiopatología , Osteoartritis de la Cadera/cirugía , Dimensión del Dolor , Educación del Paciente como Asunto/economía , Examen Físico , Estudios Prospectivos , Recuperación de la Función , Entrenamiento de Fuerza/economía , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Factores de Tiempo , Tiempo de Tratamiento/economía , Resultado del TratamientoRESUMEN
BACKGROUND: A randomized controlled trial has shown that supervised, facility-based exercise training is effective in improving glycemic control in type 2 diabetes. However, these programs are associated with additional costs. This analysis assessed the cost-effectiveness of such programs. METHODS: Analysis used data from the Diabetes Aerobic and Resistance Exercise (DARE) clinical trial which compared three different exercise programs (resistance, aerobic or a combination of both) of 6 months duration with a control group (no exercise program). Clinical outcomes at 6 months were entered for individual patients into the UKPDS economic model for type 2 diabetes adapted for the Canadian context. From this, expected life-years, quality-adjusted life-years (QALYs) and costs were estimated for all patients within the trial. RESULTS: The combined exercise program was the most expensive ($40,050) followed by the aerobic program ($39,250), the resistance program ($38,300) and no program ($31,075). QALYs were highest for combined (8.94), followed by aerobic (8.77), resistance (8.73) and no program (8.70). The incremental cost per QALY gained for the combined exercise program was $4,792 compared with aerobic alone, $8,570 compared with resistance alone, and $37,872 compared with no program. The combined exercise program remained cost-effective for all scenarios considered within sensitivity analysis. CONCLUSIONS: A program providing training in both resistance and aerobic exercise was the most cost-effective of the alternatives compared. Based on previous funding decisions, exercise training for individuals with diabetes can be considered an efficient use of resources.
Asunto(s)
Diabetes Mellitus Tipo 2/terapia , Ejercicio Físico , Entrenamiento de Fuerza/economía , Adulto , Anciano , Terapia Combinada/economía , Terapia Combinada/métodos , Análisis Costo-Beneficio , Diabetes Mellitus Tipo 2/sangre , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reino UnidoRESUMEN
OBJECTIVES: Physical and occupational therapists have started to use the Nintendo Wii™ gaming system with adults and children as part of their regular treatment. Despite the growing use of the Wii and trend towards evidence-based practice, limited evidence is available on the effectiveness of virtual reality using the Wii for children with developmental delay. The purpose of this study was to determine the feasibility and preliminary effectiveness of a low-cost gaming system for young children with developmental delay. STUDY DESIGN: Single-blind, randomised controlled trial. PARTICIPANTS AND SETTING: Forty children with developmental delay (age 39 to 58 months) who attended a segregated or integrated preschool participated in this study. All children's parents read and signed an informed consent form approved by the institutional review board. Children were assigned at random to an experimental (Wii) group (n=20) or a control group (n=20). INTERVENTION: Two weekly sessions for 10 weeks using Nintendo Wii Sports™ and Nintendo Wii Fit™, including balance, strength training and aerobics games. MAIN OUTCOME MEASURES: Participants were evaluated 1 week before and 1 week after the programme by a blinded investigator. Primary outcomes were gait speed, timed up and go test, single leg stance test, five-times-sit-to-stand test, timed up and down stairs test, 2-minute walk test and grip strength. The Gross Motor Function Measure (GMFM) was used to assess gross motor skills. RESULTS: The two groups were homogenous regarding all parameters at baseline. The Wii training was feasible and enjoyable for those in the experimental group. There were no adverse effects or injuries reported over 267 training sessions. Comparison of groups following the intervention indicated that the experimental group showed significant improvements compared with the control group in single leg stance test {mean difference 1.03 [standard deviation (SD) 1.7], 95% confidence interval (CI) 0.2 to 1.9; P=0.017}, right grip strength [mean difference 1.11 (SD 1.84), 95% CI 0.15 to 2.06; P=0.024] and left grip strength [mean difference 0.90 (SD 1.67), 95% CI 0.03 to 1.77; P=0.043]. Although changes in other outcome measures were not significant between the study groups, there were trends towards greater improvements in the experimental group compared with the control group. CONCLUSION: This study supports use of the Wii as a feasible, safe and potentially effective therapeutic tool to augment the rehabilitation of young children with developmental delay. The potential application of the Wii to increase the intensity of therapy or as a rehabilitation tool in children's homes and rural settings is an area worthy of investigation. The promising results of this study suggest that further studies are warranted to validate the potential benefits of a low-cost commercially available gaming system as a treatment strategy to supplement rehabilitation of children with disabilities.
Asunto(s)
Discapacidades del Desarrollo/rehabilitación , Terapia por Ejercicio/métodos , Modalidades de Fisioterapia , Terapia de Exposición Mediante Realidad Virtual/métodos , Preescolar , Análisis Costo-Beneficio , Discapacidades del Desarrollo/fisiopatología , Ejercicio Físico , Terapia por Ejercicio/economía , Estudios de Factibilidad , Femenino , Humanos , Masculino , Destreza Motora , Proyectos Piloto , Equilibrio Postural , Entrenamiento de Fuerza/economía , Entrenamiento de Fuerza/métodos , Método Simple Ciego , Resultado del Tratamiento , Juegos de Video/economía , Terapia de Exposición Mediante Realidad Virtual/economíaRESUMEN
SUMMARY: Using two instruments (SF-6D and EQ-5D) to estimate quality adjusted life years (QALYs), we conducted an economic evaluation of a 12-month randomized controlled trial with a 12-month follow-up study in older women to evaluate the value for money of two doses of resistance training compared with balance and tone classes. We found that the incremental QALYs estimated from the SF-6D were two- to threefold greater than those estimated from the EQ-5D. INTRODUCTION: Decision makers must continually choose between existing and new interventions. Hence, economic evaluations are increasingly prevalent. The impact of quality-adjusted life year (QALY) estimates using different instruments on the incremental cost-effectiveness ratios (ICERs) is not well understood in older adults. Thus, we compared ICERs, in older women, estimated by the EuroQol-5D (EQ-5D) and the Short Form-6D (SF-6D) to discuss implications on decision making. METHODS: Using both the EQ-5D and the SF-6D, we compared the incremental cost per QALY gained in a randomized controlled trial of resistance training in 155 community-dwelling women aged 65 to 75 years. The 12-month randomized controlled trial included a subsequent 12-month follow-up. Our focus, the follow-up study, included 123 of the 155 participants from the Brain Power study; 98 took part in the economic evaluation (twice-weekly balance and tone exercises, n = 28; once-weekly resistance training, n = 35; twice-weekly resistance training, n = 35). Our primary outcome measure was the incremental cost per QALY gained of once- or twice-weekly resistance training compared with balance and tone exercises. RESULTS: At cessation of the follow-up study, the incremental QALY was -0.051 (EQ-5D) and -0.144 (SF-6D) for the once-weekly resistance training group and -0.081 (EQ-5D) and -0.127 (SF-6D) for the twice-weekly resistance training group compared with balance and tone classes. CONCLUSION: The incremental QALYs estimated from the SF-6D were two- to threefold greater than those estimated from the EQ-5D. Given the large magnitude of difference, the choice of preference-based utility instrument may substantially impact health care decisions.