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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: Functional decline in older adults may be affected by clinical status, physical fitness, and social determinants of health. AIMS: This study aimed to explore social determinants of health and health/clinical determinants on two outcomes of functional physical capacity. METHODS AND RESULTS: Therefore, a population-based sample of 327 older adults (69 ± 7 years; 83.5% women) underwent demographical and clinical questionnaires, risk factors assessments, 6-min walk testing (walking capacity), and handgrip strength testing. Based on multivariable linear regression models, age ( - 4.05 m; - 5.3 to - 2.8), being men (71.40 m; 50.5-92.3), body mass index ( - 3.88 m; - 5.6 to - 2.1), and quality of life (18.48 m; 6.3-30.6) remained as predictive variables for walking capacity (R2 = 30.8%). In the final model for handgrip strength, age ( - 0.6% kgf; 0.89-0.2) and male sex (65.2% kgf; 55.3-75.8) remained as predictive variables. DISCUSSION: The mean values for our predicted outcomes were similar to those of healthy and physically active ones, which may be a consequence of the engagement of our sample in a lifestyle program. Also, although using the conceptual framework model to choose explanatory variables with a solid rationale, some of them may present reverse causality in this study setting, regardless of our efforts to annulate this type of bias. CONCLUSIONS: Despite exploratory analyses including contextual factors as potential predictors of walking capacity and handgrip strength, only outcomes at the individual levels were associated, either positively or negatively, with the variations presented by this studied sample of older adults.
Subject(s)
Hand Strength , Social Determinants of Health , Humans , Male , Female , Aged , Cross-Sectional Studies , Quality of Life , WalkingABSTRACT
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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The assessment of health profile in users attending such public programs may optimize tailoring of interventions oriented to reduce the risk or incidence of lifestyle-driven diseases, resulting in a potential impact on public health. Therefore, this cross-sectional study aimed to characterize the health profile of the elderly participants in the physical activity public program in southern Brazil. Therefore, we included 11 community exercise centers managed by the city of Porto Alegre (Brazil). We used simple random sampling, with sample size weight by the number of participants in each individual center. Several health domains were measured by self-reported questionnaires (e.g., cardiovascular risk factors and quality of life), office blood pressure measurements, blood assessments (i.e., lipid profile and HbA1c) and functional tests (i.e., 6-minute walk test and handgrip strength) between April/2018 to February/2019. The results are mostly reported using descriptive statistics. We observed that high self-reported prevalences regarded to cardiovascular risk factors, more specifically for sleep disorder (55%), hypercholesterolemia (54%) and hypertension (49%). Among self-reported diseases, the participants listed cardiovascular diseases (14%), previous cancer (15%), diabetes (13%), arthritis (30%), and depression (19%). The results observed in the 6-minute walk test (mean±sd 498±78.95 m) and handgrip test (mean±sd 27±8.13 kg) showed the expected levels for active elderly. Overall, the prevalences presented herein allow to contrast the estimated prevalences of older adults using a public program of physical activity to other populational estimates or single studies, fostering the future monitoring of assessments and interventions in sensible conditions (e.g., hypertension, sleep disorder) for this population.
O conhecimento do perfil de saúde dos usuários de programas públicos para promoção em saúde pode otimizar a elaboração e aperfeiçoamento de intervenções para controle doenças ou de eventos associados ao estilo de vida, com potencial impacto para a saúde pública. O objetivo deste estudo foi caracterizar o perfil da situação de saúde dos usuários idosos do programa público de atividade física, em 11 centros comunitários da cidade de Porto Alegre (RS, Brasil). Entre abril/2018 e fevereiro/2019, foram medidos domínios de saúde por questionários autoaplicados, avaliações sanguíneas e testes funcionais. O tamanho amostral foi ponderado pela quantidade de alunos atendidos por centro, com amostragem por aleatorização simples. As análises basearam-se em estatística descritiva. No total, 351 idosos (69±6 anos) foram incluídos. Houve elevadas prevalências de fatores de risco, sendo transtorno do sono (55%), hipercolesterolemia (54%), e hipertensão arterial (49%) as mais altas. Entre as doenças autorrelatadas, os participantes listaram condições cardiovasculares (14%), câncer prévio (15%), diabetes (13%), artrite reumatóide (30%) e depressão (19%). A capacidade de caminhada em 6 minutos e força de preensão manual estiveram em níveis de pessoas ativas. Este estudo possibilita contrastar as condições prevalentes dos idosos usuários de um programa público de atividade física com estimativas populacionais, servindo como levantamento inicial para futuro monitoramento de avaliações e/ou intervenções específicas às condições sensíveis nesta população.
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The aim of the present study was to evaluate the effects of 12 weeks of muscle power training (MPT) on casual blood pressure (BP) (before and after each training session) and resting BP (pre- and post-training program) in type 2 diabetes mellitus (T2DM) elderly.Methods: Twelve T2DM elderly individuals (68.75 ± 7.83 years), non-insulin-dependents participated in the present study and performed the MPT program twice a week. Casual BP was measured before and after training sessions, and resting BP was measured 48 h before the first and 48 h after the last training session.Results: Significant decrease in casual systolic (SBP) (-7.08 ± 4.12 mm Hg [effect size [ES]: -1.42 to -0.11]; p < 0.01) and diastolic (DBP) BP (-3.14 ± 1.24 mm Hg [ES: -1.24 to -0.18]; p > 0.01) was found after training sessions, without significant effect (p > 0.05) of the week along time or casual BP × week interaction. No significant change in resting SBP (-5.08 ± 8.93 mm Hg [ES: -0.41]; p = 0.07) and DBP (0.47 ± 6.06 mm Hg [ES: +0.11]; p = 0.79) was found.Conclusion: MPT was able to reduce casual BP after training sessions. However, there was no significant reduction in resting BP after MPT. Nevertheless, although not statistically significant, there were important clinical reductions in resting SBP in T2DM elderly patients.
Subject(s)
Blood Pressure/physiology , Diabetes Mellitus, Type 2/physiopathology , Diabetic Angiopathies/physiopathology , Hypertension/physiopathology , Aged , Blood Pressure Determination/methods , Female , Humans , Hypertension/therapy , Male , Middle AgedABSTRACT
BACKGROUND: Hypertension is a clinical condition highly prevalent in the elderly, imposing great risks to cardiovascular diseases and loss of quality of life. Current guidelines emphasize the importance of nonpharmacological strategies as a first-line approach to lower blood pressure. Exercise is an efficient lifestyle tool that can benefit a myriad of health-related outcomes, including blood pressure control, in older adults. We herein report the protocol of the HAEL Study, which aims to evaluate the efficacy of a pragmatic combined exercise training compared with a health education program on ambulatory blood pressure and other health-related outcomes in older individuals. METHODS: Randomized, single-blinded, multicenter, two-arm, parallel, superiority trial. A total of 184 subjects (92/center), ≥60 years of age, with no recent history of cardiovascular events, will be randomized on a 1:1 ratio to 12-week interventions consisting either of a combined exercise (aerobic and strength) training, three times per week, or an active-control group receiving health education intervention, once a week. Ambulatory (primary outcome) and office blood pressures, cardiorespiratory fitness and endothelial function, together with quality of life, functional fitness and autonomic control will be measured in before and after intervention. DISCUSSION: Our conceptual hypothesis is that combined training intervention will reduce ambulatory blood pressure in comparison with health education group. Using a superiority framework, analysis plan prespecifies an intention-to-treat approach, per protocol criteria, subgroups analysis, and handling of missing data. The trial is recruiting since September 2017. Finally, this study was designed to adhere to data sharing practices. TRIAL REGISTRATION: NCT03264443 . Registered on 29 August, 2017.
