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A randomized trial to assess the effects of physical and mental health rehabilitation for people recovering from COVID-19

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN): a multi-centre randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11466448
Enrollment
535
Registered
2020-11-23
Start date
2020-11-30
Completion date
Unknown
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

Current intervention as of 13/03/2023: A multi-centre RCT testing the clinical and cost-effectiveness of an intensive, online, supervised, group, home-based rehabilitation programme that supports long

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 19/03/2021: 1. UK resident 2. Aged =18 years 3. = 3 months after any UK hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support 4. Substantial, as defined by the participant, COVID-19 related physical and/or mental health problems 5. Access to, and ability/support to use, email, text message, internet video, including webcam and audio 6. Ability to provide informed consent 7. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends Previous inclusion criteria: 1. Aged =18 years 2. =3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support 3. Substantial, as defined by the participant, COVID-19 related physical and/or mental health problems 4. Access to, and ability/support to use email, text message, internet video, including webcam and audio 5. Ability to provide informed consent 6. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends

Exclusion criteria

Exclusion criteria: 1. Exercise contraindicated 2. Severe mental health problems preventing engagement 3. Previous randomisation in the present trial 4. Patient already engaging in, or planning to engage in a conflicting NHS delivered rehabilitation programme in the next 12 weeks 5. A member of the same household has previously been randomised in the present trial

Design outcomes

Primary

MeasureTime frame
Health-related quality of life (HRQoL) measured using the PROMIS® 29+2 Profile v2.1 (PROPr) at 3 months post-randomisation

Secondary

MeasureTime frame
Measured at 3, 6 and 12 months post-randomisation: 1. Health-related quality of life (HRQoL) measured using PROPr 2. Dyspnoea measured using PROMIS dyspnoea severity Short Form 3. Cognitive function measured using PROMIS Neuro-QoL Short Form v2.0 - Cognitive Function 4. Health utility measured using Euroqol EQ-5D-5L 5. Physical activity participation measured using the International Physical Activity Questionnaire (IPAQ short-form) 6. PTSD symptom severity measured using the Impacts of Events Scale-Revised (IES-R) 7. Depressive and anxiety symptoms measured using the Hospital Anxiety and Depression Scale (HADS) 8. Work status measured using time lost from work (paid/unpaid) and patient-borne health costs 9. Health and social care resource use measured using participant self-report and NHS records 10. Death measured using GP data

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026