Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial

Abstract

Objectives The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. Trial design Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. Participants Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥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 able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. Exclusion criteria: 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. Intervention and comparator Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). Main outcomes The primary outcome is health-related quality of life (HRQoL) – PROMIS® 29+2 Profile v2.1 (PROPr) – measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. Randomisation Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. Blinding (masking) To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. Numbers to be randomised (sample size) A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. Trial Status Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. Trial registration ISRCTN:11466448, 23rd November 2020 Full protocol The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Acute exercise increases immune responses to SARS CoV-2 in a previously infected man

“…Individuals that regularly exercise have improved clinical outcomes and symptomology following SARS-CoV-2 infection ( Cummins et al, 2021 ; de Souza et al, 2021 ; Sallis et al, 2021 ). This has raised awareness on the potential for lifestyle changes, such as exercise, to safeguard against viral disease and has encouraged investigations into the role of exercise in the recovery of the so-called long COVID syndrome ( McGregor et al, 2021 ; Udina et al, 2021 ). The frequent mobilization and redistribution of SARS-CoV-2 specific T-cells with each bout of exercise, combined with an increased lymphatic transportation of neutralizing antibodies, is one potential mechanism by which exercise can improve immunity against SARS-CoV-2 ( Simpson and Katsanis, 2020 ); but how exercise affects cellular and humoral immunity against this novel coronavirus has not been determined.…”

The Norwegian PROMIS-29: psychometric validation in the general population for Norway

“…The PROMIS-29 adult profile is a brief generic health measure comprising 29-items from the PROMIS domains of anxiety, depression, fatigue, pain (intensity and interference), physical function, sleep disturbance, satisfaction with participation in social roles (social participation) [ 2 ]. The PROMIS-29 has had rapid uptake since it became available in the last decade, including translation into over 40 languages [ 2 ], evaluation of measurement properties in different countries and populations [ 6 – 8 ], and application in research, including randomized controlled trials [ 9 – 11 ]. The instrument has also been used in crosswalks or mapping to other widely used PROMs including the EuroQol EQ-5D [ 12 ].…”

Systematic review of process evaluations of interventions in trials investigating sedentary behaviour in adults

“…Overall 464 unique articles were identified once 14 duplicates were removed. Two reviewers completed title and abstract screening identifiying 29 for full-text screening; of these, 21 met our criteria, 8 are ongoing studies,56–63 8 are completed trials where a process evaluation was conducted but results are not available,64–71 and 5 are completed studies with process evaluation results available 72–76. As with the studies that were synthesised in our review, these included participants from a range of different ages and health conditions for example, insomnia disorder, diabetes, heart disease, hip fracture and obesity and generally focused on increasing physical activity, reducing sedentary behaviour or were lifestyle or weight loss interventions.…”