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Effects of a 16-week home-based exercise training programme on health-related quality of life, functional capacity, and persistent symptoms in survivors of severe/critical COVID-19: a randomised controlled trial

Longobardi et al., British Journal of Sports Medicine, doi:10.1136/bjsports-2022-106681, NCT04615052
May 2023  
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RCT 50 post-severe/critical COVID-19 patients in Brazil, showing improved health-related quality of life with an exercise program (3 times a week, ~60–80 minutes/session, for 16 weeks).
Longobardi et al., 10 May 2023, Single Blind Randomized Controlled Trial, Brazil, peer-reviewed, 12 authors, study period November 2020 - April 2022, trial NCT04615052 (history). Contact: hars@usp.b.
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Effects of a 16-week home-based exercise training programme on health-related quality of life, functional capacity, and persistent symptoms in survivors of severe/critical COVID-19: a randomised controlled trial
Igor Longobardi, Karla Goessler, Gersiel Nascimento De Oliveira Júnior, Danilo Marcelo Leite Do Prado, Jhonnatan Vasconcelos Pereira Santos, Matheus Molina Meletti, Danieli Castro Oliveira De Andrade, Saulo Gil, João Antonio Spott De Oliveira Boza, Fernanda Rodrigues Lima, Bruno Gualano, Professor Hamilton Roschel
British Journal of Sports Medicine, doi:10.1136/bjsports-2022-106681
Background Long-lasting effects of COVID-19 may include cardiovascular, respiratory, skeletal muscle, metabolic, psychological disorders and persistent symptoms that can impair health-related quality of life (HRQoL). We investigated the effects of a home-based exercise training (HBET) programme on HRQoL and health-related outcomes in survivors of severe/critical COVID-19. Methods This was a single-centre, single-blinded, parallelgroup, randomised controlled trial. Fifty survivors of severe/ critical COVID-19 (5±1 months after intensive care unit discharge) were randomly allocated (1:1) to either a 3 times a week (~60-80 min/session), semi-supervised, individualised, HBET programme or standard of care (CONTROL). Changes in HRQoL were evaluated through the 36-Item Short-Form Health Survey, and physical component summary was predetermined as the primary outcome. Secondary outcomes included cardiorespiratory fitness, pulmonary function, functional capacity, body composition and persistent symptoms. Assessments were performed at baseline and after 16 weeks of intervention. Statistical analysis followed intention-to-treat principles. Results After the intervention, HBET showed greater HRQoL score than CONTROL in the physical component summary (estimated mean difference, EMD: 16.8 points; 95% CI 5.8 to 27.9; effect size, ES: 0.74), physical functioning (EMD: 22.5 points, 95% CI 6.1 to 42.9, ES: 0.83), general health (EMD: 17.4 points, 95% CI 1.8 to 33.1, ES: 0.73) and vitality (EMD: 15.1 points, 95% CI 0.2 to 30.1, ES: 0.49) domains. 30-second sit-to-stand (EMD: 2.38 reps, 95% CI 0.01 to 4.76, ES: 0.86), and muscle weakness and myalgia were also improved in HBET compared with CONTROL (p<0.05). No significant differences were seen in the remaining variables. There were no adverse events. Conclusion HBET is an effective and safe intervention to improve physical domains of HRQoL, functional capacity and persistent symptoms in survivors of severe/critical COVID-19. Trial registration number NCT04615052. ORCID iDs
Contributors Designed research: IL, KG, DCOdA, SG, FRL, BG and HR. Conducted the research: IL and KG. Contributed to data collection: IL, KG, GNdOJ, DMLdP, JVPS, MMM and JASdOB. Analysed data/statistical analysis: IL and HR. Drafted the manuscript: IL, BG and HR. Guarantor: HR. All authors reviewed the manuscript critically and approved the final version. The corresponding author attests that all listed authors meet authorship criteria. Competing interests None declared. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Patient consent for publication Consent obtained directly from patient(s). Ethics approval This study involves human participants. This study was performed in line with the principles of the 1964 Declaration of Helsinki. Ethics approval was obtained from the local Ethical Review Board (CAPPesq; No. 31303720.7.0000.0068). Participants gave informed consent to participate in the study before taking part. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement All data relevant to the study are included in the article or uploaded as online supplemental information. Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and..
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