Methodological rigor and quality of reporting of clinical trials published with physical activity interventions: A report from the Strengthening the Evidence in Exercise Sciences Initiative (SEES Initiative).

BACKGROUND: This study addresses the need for improved transparency and reproducibility in randomized clinical trials (RCTs) within the field of physical activity (PA) interventions. Despite efforts to promote these practices, there is limited evidence on the adherence to established reporting and methodological standards in published RCTs. The research, part of the Strengthening the Evidence in Exercise Sciences Initiative (SEES Initiative) in 2020, assessed the methodological standards and reporting quality of RCTs focusing on PA interventions. METHODS: RCTs of PA advice or exercise interventions published in 2020 were selected. Monthly searches were conducted on PubMed/MEDLINE targeting six top-tier exercise science journals. Assessments were conducted by two independent authors, based on 44 items originally from CONSORT and TIDieR reporting guidelines. These items were divided into seven domains: transparency, completeness, participants, intervention, rigor methodology, outcomes and critical analysis. Descriptive analysis was performed using absolute and relative frequencies, and exploratory analysis was done by comparing proportions using the χ2 test (α = 0.05). RESULTS: Out of 1,766 RCTs evaluated for eligibility, 53 were included. The median adherence to recommended items across the studies was 30 (18-44) items in individual assessments. Notably, items demonstrating full adherence were related to intervention description, justification, outcome measurement, effect sizes, and statistical analysis. Conversely, the least reported item pertained to mentioning unplanned modifications during trials, appearing in only 11.3% of studies. Among the 53 RCTs, 67.9% reported having a registration, and these registered studies showed higher adherence to assessed items compared to non-registered ones. CONCLUSIONS: In summary, while critical analysis aspects were more comprehensively described, aspects associated with transparency, such as protocol registrations/modifications and intervention descriptions, were reported suboptimally. The findings underscore the importance of promoting resources related to reporting quality and transparent research practices for investigators and editors in the exercise sciences discipline.

The "home-based exercise for breast and prostate cancer patients during treatment-a feasibility trial" (BENEFIT CA trial): rationale and methodological protocol.

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.