REGAIN [COVID-19]
Research type
Research Study
Full title
Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a multi-centre randomised controlled trial
IRAS ID
288362
Contact name
Gordon McGregor
Contact email
Sponsor organisation
UHCW NHS Trust
ISRCTN Number
ISRCTN11466448
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
There is a substantial unmet need in the treatment and rehabilitation of people experiencing long-term effects from COVID-19. Existing NHS rehabilitation services have insufficient capacity to deal with demand, and delivery of rehabilitation healthcare in traditional group settings is currently suspended. However, virtual outpatient consultations have become commonplace in preference to face-to-face appointments. The implementation of personalised on-line consultation and treatment, whilst not well developed in the U.K., has been rapidly accelerated. On-line delivery of personalised rehabilitation may be beneficial for COVID-19 survivors who have ongoing physical and/or mental health problems.
The objective of this trial is to run a multi-centre randomised controlled trial testing the clinical and cost-effectiveness of an intensive, on-line, supervised, group, home-based rehabilitation programme that supports long-term physical and mental health recovery (REGAIN) vs. best-practice usual care for people discharged from hospital (>3/12) after COVID-19 infection.
The intervention group will receive an eight-week, on-line, supervised, home-based, exercise rehabilitation programme with behavioural, motivational and mental health support. The intervention includes: 1) individual assessment; 2) supervised home-based exercise programme with pre-recorded and live sessions; 3) one-to-one and group on-line psychosocial and motivational support and education. The control group will receive a single, on-line, one-to-one, practitioner consultation with general advice on safe and effective physical activity.
Outcomes will be assessed at baseline, three, six and 12 months (post-randomisation). The primary outcome measurement is health related quality of life: PROMIS® 29+2 Profile v2.1 (PROPr) measured at three months post-randomisation.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0235
Date of REC Opinion
6 Nov 2020
REC opinion
Further Information Favourable Opinion