U.K. trial Rehabilitation exercise and psychological support after Covid 19 infection (REGAIN) Warwick University

Kalliope

Kalliope

Senior Member (Voting Rights)
This post and all to post #12 have been moved here from the BPS attempts at psychologising Long Covid thread. Links to Warwick University and National Institute of Health Research web pages in this post

Eurekalert: New clinical trial to test whether structured exercise benefits 'long covid' patients

Researchers at the University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) NHS Trust in the UK are to investigate whether a tailored online exercise and support programme would benefit those experiencing long-term symptoms of Covid-19 - what has been dubbed 'long Covid'.

The results of the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial will help to guide recommendations for treatment of people with long Covid, for whom there is currently only limited advice and guidelines available.

ETA
Due to social distancing restrictions, the trial will be conducted entirely online.

...

Dr Gordon McGregor, a Clinical Exercise Physiologist, is Chief Investigator for the REGAIN trial at Warwick Clinical Trials Unit and UHCW NHS Trust.

Dr McGregor said: "At a critical time in the treatment and recovery of patients with Covid-19 we are proud to be at the forefront of research into providing world class long term care.

"The main aim of the REGAIN trial is to find out if we can improve people's quality of life with a single session of advice and support or an 8 week exercise and support programme. It's not just about improving fitness. It's about improving any aspect of people's lives; whatever they feel is important to them, or getting back what they may have lost after having Covid-19. For some people, that might be physical, for others it might be mental, or it could be a bit of both.
 
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Kalliope said:
Eurekalert: New clinical trial to test whether structured exercise benefits 'long covid' patients

Researchers at the University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) NHS Trust in the UK are to investigate whether a tailored online exercise and support programme would benefit those experiencing long-term symptoms of Covid-19 - what has been dubbed 'long Covid'.

The results of the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial will help to guide recommendations for treatment of people with long Covid, for whom there is currently only limited advice and guidelines available.

ETA
Due to social distancing restrictions, the trial will be conducted entirely online.

...

Dr Gordon McGregor, a Clinical Exercise Physiologist, is Chief Investigator for the REGAIN trial at Warwick Clinical Trials Unit and UHCW NHS Trust.

Dr McGregor said: "At a critical time in the treatment and recovery of patients with Covid-19 we are proud to be at the forefront of research into providing world class long term care.

"The main aim of the REGAIN trial is to find out if we can improve people's quality of life with a single session of advice and support or an 8 week exercise and support programme. It's not just about improving fitness. It's about improving any aspect of people's lives; whatever they feel is important to them, or getting back what they may have lost after having Covid-19. For some people, that might be physical, for others it might be mental, or it could be a bit of both.
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Apologies if you’re already aware @PhysiosforME tagging just in case you’ve not seen
 
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Kalliope said:
Dr Gordon McGregor, a Clinical Exercise Physiologist, is Chief Investigator for the REGAIN trial at Warwick Clinical Trials Unit and UHCW NHS Trust.

Dr McGregor said: "At a critical time in the treatment and recovery of patients with Covid-19 we are proud to be at the forefront of research into providing world class long term care.
Click to expand...

Presumably it will be a case of measuring outcome with a questionnaire 'was the treatment brilliant?' with a tick box for 'surreally excellent'.

I am beginning to realise that those five words 'we are proud to be' mean 'we know we are complete jerks, and these five words prove it but aren't we amazing?'.
 
Kalliope said:
Wasn't sure which thread to put this in

Eurekalert: New clinical trial to test whether structured exercise benefits 'long covid' patients

Researchers at the University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) NHS Trust in the UK are to investigate whether a tailored online exercise and support programme would benefit those experiencing long-term symptoms of Covid-19 - what has been dubbed 'long Covid'.

The results of the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial will help to guide recommendations for treatment of people with long Covid, for whom there is currently only limited advice and guidelines available.

ETA
Due to social distancing restrictions, the trial will be conducted entirely online.

...

Dr Gordon McGregor, a Clinical Exercise Physiologist, is Chief Investigator for the REGAIN trial at Warwick Clinical Trials Unit and UHCW NHS Trust.

Dr McGregor said: "At a critical time in the treatment and recovery of patients with Covid-19 we are proud to be at the forefront of research into providing world class long term care.

"The main aim of the REGAIN trial is to find out if we can improve people's quality of life with a single session of advice and support or an 8 week exercise and support programme. It's not just about improving fitness. It's about improving any aspect of people's lives; whatever they feel is important to them, or getting back what they may have lost after having Covid-19. For some people, that might be physical, for others it might be mental, or it could be a bit of both.
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This looks to be the same group behind this, Protocol for a randomised controlled feasibility trial of exercise rehabilitation for people with POTS: the PULSE study (2020) MacGregor et al
 
the REGAIN trial
https://warwick.ac.uk/fac/sci/med/research/ctu/trials/regain
https://fundingawards.nihr.ac.uk/award/NIHR132046

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.

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.

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. 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.

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. Control: Single, on-line, one-to-one, practitioner consultation with general advice on safe and effective physical activity.

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.

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.

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.

Team: Lay partners, ICUsteps charity, clinical exercise physiology, physiotherapy, health psychology, psychiatry, critical care and respiratory medicine, general practice, statistics, health economics, clinical trialists. 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).
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Award:
£1,191,977.49
 
Many survivors of novel coronavirus infections (SARS-Cov and MERS-Cov) had substantial physical, psychological and neurological morbidity for up to 12 months.
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My bolding.

I see no point in reading further when it starts with such a blatant misdirection.

According to my understanding many of the people of whom they speak have still not recovered.
 
 
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The comments on the new tweet are worth reading. Not many happy campers. Turns out the "small militant minority" is actually a large organic supermajority in the patient population.

It's really the egregiousness of those lies that get me. They all repeated it in response to the NICE guidelines. They know it's a lie. It can't even be defended that it's a blatant lie. And yet they feel absolutely no shame in repeating this obvious. People with no integrity should not work in medicine. Full stop.



 
Someone mentioned that this represents about 1/4 of the research budget dedicated to LC. Sounds right but anyone has a link handy for the total sum? To be sure.

That would be a serious dereliction of duty, to continue to waste scarce research funding on a failed ideology that is being dismantled as this is happening.

There was a retort from one of the PIs that this excludes people with PEM (or exertion intolerance, whatever, they don't seem to grasp what PEM is at all), which obviously makes no sense as it's one of the most common symptoms, basically a defining feature of LC as much as it is for ME.

Either they don't listen to the patients, or do and just don't care because the conclusions are already written.
 
rvallee said:
Someone mentioned that this represents about 1/4 of the research budget dedicated to LC. Sounds right but anyone has a link handy for the total sum? To be sure.
Click to expand...

On the 12th of November, NIHR announced a £20m research call, closing on the 9th of December:

https://www.nihr.ac.uk/news/new-20m...ysical-and-mental-effects-of-long-covid/26163

They also announced on the 10th of December that they were funding projects totalling £5.5m, including REGAIN:

https://www.nihr.ac.uk/news/nihr-fu...vestigate-long-term-impacts-of-covid-19/26390

REGAIN isn't the only rehabilitative programme that was funded; £781,964 went to UCL for "supported remote rehabilitation post Covid-19".

Edit to add: the UCL one seems to be described here as well:
https://www.ucl.ac.uk/news/2020/aug/new-rehabilitation-app-aid-recovery-covid-19-long-haulers
 
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