A tele-health intervention to increase physical fitness in people with spinal cord injury and cardiometabolic disease or risk factors: a pilot randomized controlled trial.

Bombardier, Charles H; Dyer, Joshua R; Burns, Patricia; Crane, Deborah A; Takahashi, Melissa M; Barber, Jason; Nash, Mark S

Bombardier, Charles H; Dyer, Joshua R; Burns, Patricia; Crane, Deborah A; Takahashi, Melissa M; Barber, Jason; Nash, Mark S.

Afiliación

Bombardier CH; Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA. chb@uw.edu.
Dyer JR; Peacehealth Medical Group, Vancouver, WA, USA.
Burns P; The Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, FL, USA.
Crane DA; Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.
Takahashi MM; Department of Ophthalmology, University of Washington, Seattle, WA, USA.
Barber J; Department of Neurosurgery, University of Washington, Seattle, WA, USA.
Nash MS; Departments of Neurological Surgery, Physical Medicine & Rehabilitation and Physical Therapy, University of Miami Miller School of Medicine, Miami, FL, USA.

Spinal Cord ; 59(1): 63-73, 2021 Jan.

Article en En | MEDLINE | ID: mdl-32694748

RESUMEN

STUDY DESIGN: Clinical trial. OBJECTIVES: We used a single-blind parallel-group design to test the feasibility and preliminary efficacy of a telehealth-based physical activity counseling intervention to increase physical fitness in people with SCI. SETTING: Seattle, Washington, United States. METHODS: We recruited under-active, manual wheelchair-using adults at least 1-year post-SCI who had at least two cardiometabolic risk factors/diseases. Participants underwent baseline tests of peak cardiorespiratory fitness; lipids, glucose and insulin; muscle and fat mass; self-reported physical activity, depression, pain and other factors. Participants were assigned 1:1 to treatment vs. usual care (UC) control conditions via concealed computerized randomization. Treatment was delivered via telephone and adapted from the 16-session Diabetes Prevention Program. All baseline tests were repeated at 6 months. Prespecified feasibility goals were to recruit at least nine participants/quarter and retain 85% with complete fitness testing at 6 months. Prespecified efficacy goals were to demonstrate at least a medium treatment effect size (0.50) on fitness, self-reported physical activity, and other outcomes. RESULTS: Seven participants were randomized to treatment, 8 to UC over 15 months. Maximum recruitment was only 5.4 participants/quarter. Thirteen (87%) of participants were retained. The effects of treatment on fitness and most cardiometabolic risk factors did not meet expectations, whereas the effects on self-reported physical activity, depression, and pain did meet expectations. CONCLUSIONS: The study did not meet key efficacy and feasibility objectives, yet there were some promising effects on self-report measures and lessons to be learned for designing future trials.

Asunto(s)

Enfermedades Cardiovasculares; Terapia por Ejercicio; Aptitud Física; Traumatismos de la Médula Espinal; Telemedicina; Adulto; Enfermedades Cardiovasculares/complicaciones; Femenino; Humanos; Masculino; Persona de Mediana Edad; Proyectos Piloto; Método Simple Ciego; Traumatismos de la Médula Espinal/complicaciones; Traumatismos de la Médula Espinal/terapia

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Traumatismos de la Médula Espinal / Enfermedades Cardiovasculares / Aptitud Física / Telemedicina / Terapia por Ejercicio Tipo de estudio: Clinical_trials / Etiology_studies / Guideline Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Spinal Cord Asunto de la revista: NEUROLOGIA Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

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