Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial

• Published in: BMJ (Online) 2024-02, Vol.384, p.e076506-e076506
• Main Authors: McGregor, Gordon, Sandhu, Harbinder, Bruce, Julie, Sheehan, Bartholomew, McWilliams, David, Yeung, Joyce, Jones, Christina, Lara, Beatriz, Alleyne, Sharisse, Smith, Jessica, Lall, Ranjit, Ji, Chen, Ratna, Mariam, Ennis, Stuart, Heine, Peter, Patel, Shilpa, Abraham, Charles, Mason, James, Nwankwo, Henry, Nichols, Vivien, Seers, Kate, Underwood, Martin
• Format: Article
• Language: English
• Subjects: Adult; Adverse events; Anxiety; Chronic fatigue syndrome; Cognitive ability; Complications; Cost-Benefit Analysis; COVID-19; Exercise; Fatigue; Female; Hospitals; Humans; Internet; Intervention; Male; Medical research; Mental depression; Mental health; Middle Aged; Pain; Pandemics; Physical fitness; Post traumatic stress disorder; Post-Acute COVID-19 Syndrome; Psychiatric Rehabilitation; Quality of Life; Questionnaires; Recovery (Medical); Rehabilitation; Treatment Outcome
• ISSN: 1756-1833; 1756-1833
• DOI: 10.1136/bmj-2023-076506

AbstractObjectiveTo evaluate whether a structured online supervised group physical and mental health rehabilitation programme can improve health related quality of life compared with usual care in adults with post-covid-19 condition (long covid).DesignPragmatic, multicentre, parallel group, superiority randomised controlled trial.SettingEngland and Wales, with home based interventions delivered remotely online from a single trial hub.Participants585 adults (26-86 years) discharged from NHS hospitals at least three months previously after covid-19 and with ongoing physical and/or mental health sequelae (post-covid-19 condition), randomised (1:1.03) to receive the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) intervention (n=298) or usual care (n=287).InterventionsBest practice usual care was a single online session of advice and support with a trained practitioner. The REGAIN intervention was delivered online over eight weeks and consisted of weekly home based, live, supervised, group exercise and psychological support sessions.Main outcome measuresThe primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months. Secondary outcomes, measured at three, six, and 12 months, included PROMIS subscores (depression, fatigue, sleep disturbance, pain interference, physical function, social roles/activities, and cognitive function), severity of post-traumatic stress disorder, general health, and adverse events.ResultsBetween January 2021 and July 2022, 39 697 people were invited to take part in the study and 725 were contacted and eligible. 585 participants were randomised. Mean age was 56 (standard deviation (SD) 12) years, 52% were female participants, mean health related quality of life PROMIS-PROPr score was 0.20 (SD 0.17), and mean time from hospital discharge was 323 (SD 144) days. Compared with usual care, the REGAIN intervention led to improvements in health related quality of life (adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02) at three months, driven predominantly by greater improvements in the PROMIS subscores for depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P