Title: Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN)
Funder: Department of Health and Social Care

Abstract: What is the problem?_x000D_ COVID-19 is a serious infection affecting many thousands of people in the U.K. People recovering from COVID-19 often feel very weak, breathless and tired. A lot of people are also worried and frightened. For most people, these problems will get better on their own. Life will get back to how it was before they were ill with COVID-19. For others, these mental and physical health problems will persist. Some people will still struggle with their mental and physical health a long time after leaving hospital. Even after many months of recovery at home, daily life may still be difficult and very different to how it was before they were ill with COVID-19._x000D_ _x000D_ What are we trying to find out? _x000D_ People with long-term health problems can improve their mental and physical health by joining exercise and support groups. These groups are often run by the NHS in hospitals and gyms. People recovering from COVID-19 may also benefit. Regular exercise and mental health support, may improve breathing, fitness and mood, helping people return to their daily lives._x000D_ _x000D_ Because gyms are closed, and there are so many people recovering from COVID-19, the NHS cannot provide exercise and support groups for everyone who may need them. We need to test other ways of providing these groups. One way is to provide home programmes that are supervised ‘on-line’. Trained staff can speak to people via video link and run live exercise and support sessions for people to watch and take part in. This can be done one-to-one or in small groups._x000D_ _x000D_ What treatments are we testing?_x000D_ For people who are still struggling many months after being ill with COVID-19, we want to find out if an eight-week programme of supervised, on-line, home-based exercise and mental health support will help people get back to normal. We will compare this with a single on-line session of advice and support. The study will recruit 535 people who will be placed by chance in either the supervised group or the advice group._x000D_ _x000D_ How will we know if the treatment helps?_x000D_ We have spoken to people recovering from COVID-19 and their families. They told us that less shortness of breath, tiredness and worry, along with more confidence and better health are important. They also told us that they are worried about how slow their recovery has been and that there has been little support to help them get back to a normal life. We will ask people to fill in quality of life questionnaires a over 12 months. This will help us to find out if our supervised, on-line, exercise and support programme does or does not help people recovering from COVID-19 and if it represents good value for the NHS.

Lay abstract: Background: Many survivors of novel coronavirus infections (SARS-Cov and MERS-Cov) had substantial physical, psychological and neurological morbidity for up to 12 months. Similar longer-term consequences of COVID-19 are now apparent. Case level mental health diagnoses along with disabling fatigue, breathlessness and muscle weakness are commonly reported. There is a large population of COVID-19 survivors in the UK with persistently reduced quality of life, even after several months of recovery. Exercise and psychological rehabilitation may help but existing NHS rehabilitation services have insufficient capacity. Alternative delivery models must be tested._x000D_ _x000D_ Design/setting: Two-arm multi-centre RCT with parallel process evaluation and 1-month internal pilot (n=35). Treatment allocation of 1:1.03 randomised by minimisation based on age, assisted ventilation, and case level mental health disorder. _x000D_ _x000D_ Population: Adults recovering from COVID-19, more than 3 months after hospital discharge with continued physical and/or mental health sequelae, and access to internet video. Exclusions are exercise contraindications and severe mental health problems preventing engagement._x000D_ _x000D_ Health Technology Assessment: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN) intervention is an eight-week, on-line, supervised, home-based, exercise rehabilitation programme with behavioural, motivational and mental health support._x000D_ REGAIN 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._x000D_ _x000D_ Control: Single, on-line, one-to-one, practitioner consultation with general advice on safe and effective physical activity._x000D_ _x000D_ Outcomes. All measures completed on-line at baseline and 3 (post-intervention), 6- and 12-months post-randomisation. Primary: PROMIS® 29+2 Quality of Life questionnaire at 3 months. Secondary: dyspnoea, EQ-5D-5L, anxiety/depression, PTSD symptom severity, cognitive function, work status, physical activity, health and social care use, cost-effectiveness._x000D_ _x000D_ Sample size: Allowing for 10% loss to follow-up, 535 (263 control, 272 intervention) participants are required to achieve 90% power at 5% significance level; based on standardised mean effect size of 0.3 (i.e. three points), intervention group size of 8 and an intra cluster coefficient of 0.01._x000D_ _x000D_ Analysis. Summarised/reported as per CONSORT, using intention-to-treat analyses. Treatment effects (with 95% CI) estimated with hierarchical linear regression models, adjusted for patient-level covariates. We will estimate and adjust for site effects as a random variable in the model. Categorical data analysed using logistic regression models. Pre-specified, exploratory sub-group analyses will examine the interaction of treatment assignment. Prospective cost-effectiveness assessed as incremental cost per QALY estimates and credible intervals, cost-effectiveness acceptability curve and value-of-information analyses._x000D_ _x000D_ Team: Lay partners, ICUsteps charity, clinical exercise physiology, physiotherapy, health psychology, psychiatry, critical care and respiratory medicine, general practice, statistics, health economics, clinical trialists._x000D_ _x000D_ Timeline (month): set-up (0-1); internal pilot (2-3); recruitment (2-9); primary outcome (5-12); analysis/dissemination (13-14), 6-month follow-up (8-15), 12-month follow-up (15-22).

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL
Health categories: INFECTION