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BACKGROUND: Physical activity has been shown to benefit patients undergoing adjuvant cancer therapy. Although exercise interventions may be applied in several settings, most trials have focused on specialized facilities for their interventions. While these approaches benefit the access for individuals living near exercise centers, it hampers the assessment of real-world effectiveness. Therefore, evaluating the feasibility and implementation of home-based models of exercise training, especially in low-to-middle-income settings, may inform future physical activity trials and programs. In this article, we present the protocol for the BENEFIT CA trial, which aims to assess the implementation of a remote exercise intervention for patients with breast cancer or prostate cancer, primarily quantifying adherence to an exercise program. METHODS: This is a 12-week study, utilizing a non-randomized, single-arm design to assess the feasibility of a home-based exercise training. The intervention is remotely guided, and participants also receive an educational component about cancer and exercise. The study aims to recruit 40 patients diagnosed with breast cancer and 40 patients diagnosed with prostate cancer, all of whom undergoing active hormonal treatment. The primary outcome is the level of adherence, indicated as the proportion of performed exercise episodes. Secondary outcomes include recruitment rates, fatigue, quality of life, and functional capacity. Adverse events will be monitored throughout the study. Because this is a feasibility trial, the statistical analysis plan is based on descriptive statistics, which encompasses an intention-to-treat analysis and a plan for handling missing data. DISCUSSION: This is a low-cost feasibility study to orient the design of a wide-range, pragmatic phase 3 trial based on remote exercise intervention. With this study, we aim to better understand the adherence and implementation strategies regarding home-based exercise for the proposed population and, in the near future, move forward to a randomized clinical trial. In addition, this trial may contribute to engage patients with cancer in exercise programs throughout their treatment and beyond. TRIAL REGISTRATION: This trial has been approved by the Hospital de Clínicas de Porto Alegre Ethics Committee/IRB (48,869,621.9.0000.5327), and it is registered at Clinicaltrials.gov (NCT05258526), registered on February 25, 2022, prior to the beginning of the study.
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BACKGROUND: The prevalence of type 2 diabetes mellitus increases with age, and people with type 2 diabetes are more affected by reductions in functional performance. Although exercise interventions are recommended for people with diabetes, it is relevant to assess the effects of different training modes on the available functional outcomes. Therefore, our purpose was to systematically assess the effect of different physical exercise modalities in patients with type 2 diabetes with an average age of 45 years or older on outcomes used to measure functional capacity. METHODS: A systematic review and meta-analysis of controlled trials was conducted. Seven databases were searched from January 1987 to December 2021 (PubMed, Physiotherapy Evidence Database, Cochrane Library, SPORTDiscus, and in grey literature: Open Grey and Google Scholar). Eligible studies should last 8 weeks or longer, comparing structured exercise training and non-exercise control for one out of six pre-specified functional capacity outcomes (Timed Up and Go test, chair stands, walking performance, upper-limb muscle strength, lower-limb muscle strength, physical fitness parameter), in patients with type 2 diabetes, aged ≥ 45 years. The risk of bias was assessed with the Downs & Black checklist. Pooled mean differences were calculated using a random-effects model, followed by sensitivity and meta-regression analyses. RESULTS: Of 18,112 references retrieved, 29 trials (1557 patients) were included. Among these, 13 studies used aerobic training, 6 studies used combined training, 4 studies used resistance training, 3 studies had multiple intervention arms and 3 studies used other types of training. Exercise training was associated with an increase in functional capacity outcomes, as reflected by changes in 6-min walk test (n = 8) [51.6 m; 95% CI 7.6% to 95.6%; I2 92%], one-repetition maximum leg-press (n = 3) [18.0 kg; 95% CI 4.0% to 31.9%; I2 0%], and maximum oxygen consumption (VO2max) (n = 20) [2.41 mL/kg·min; 95% CI 1.89% to 2.92%; I2 100%] compared with control groups. In sensitivity and subgroup analyses using VO2max as outcome and stratified by type of study (randomized and non-randomized controlled clinical trials), duration of diabetes diagnosis, and sex, we observed overlapping confidence intervals. Meta-regression showed no association between glycated hemoglobin (HbA1C) levels and VO2max [p = 0.34; I2 99.6%; R2 = 2.6%]. In addition, the quality of the included studies was mostly low. CONCLUSION: The results indicate that structured physical exercise programs might improve functional capacity in patients with type 2 diabetes, except for the upper-limb muscle strength. However, we could not identify potential effect predictors associated with directional summary estimates. Trial registration This systematic review was registered in the PROSPERO international prospective register of systematic reviews (CRD42020162467); date of registration: 12/15/2019. The review protocol is hosted at the Open Science Framework (OSF) (Preprint https://doi.org/10.31219/osf.io/kpg2m ).
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This randomized clinical trial compared the neuromuscular adaptations induced by concurrent training (CT) performed with repetitions to concentric failure and not to failure in elderly men. Fifty-two individuals (66.2⯱â¯5.2â¯years) completed the pre- and post-measurements and were divided into three groups: repetitions to failure (RFG, nâ¯=â¯17); repetitions not to failure (NFG, nâ¯=â¯20); and repetitions not to failure with total volume equalized to RFG (ENFG, nâ¯=â¯15). Participants were assessed in isometric knee extension peak torque (PTiso), maximal strength (1RM) in the leg press (LP) and knee extension (KE) exercises, quadriceps femoris muscle thickness (QF MT), specific tension, rate of torque development (RTD) at 50, 100 and 250â¯ms, countermovement jump (CMJ) and squat jump (SJ) performance, as well as maximal neuromuscular activity (EMGmax) of the vastus lateralis (VL) and rectus femoris (RF) muscles. CT was performed over 12â¯weeks, twice weekly. Along with each specific strength training program, each group also underwent an endurance training in the same session. After training, all groups improved similarly and significantly in LP and KE 1RM, PTiso, CMJ and SJ performance, RTD variables, specific tension, and VL EMGmax, (Pâ¯<â¯0.05-0.001). QF MT improved only in RFG and ENFG (Pâ¯<â¯0.01). These results suggest that repetitions until concentric failure does not provide further neuromuscular performance gains and muscle hypertrophy, and that even a low number of repetitions relative to the maximal possible (i.e., 50%) optimizes neuromuscular performance in elderly men. Moreover, training volume appears to be more important for muscle hypertrophy than training using maximal repetitions.