Clinical effectiveness of an online group physical & mental health rehab programme for post-covid-19 condition REGAIN study, 2024, McGregor+

SNT Gatchaman

SNT Gatchaman

Senior Member (Voting Rights)
Staff member
Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition REGAIN study: multicentre randomised controlled trial
Gordon McGregor; Harbinder Sandhu; Julie Bruce; Bartholomew Sheehan; David McWilliams; Joyce Yeung; Christina Jones; Beatriz Lara; Sharisse Alleyne; Jessica Smith; Ranjit Lall; Chen Ji; Mariam Ratna; Stuart Ennis; Peter Heine; Shilpa Patel; Charles Abraham; James Mason; Henry Nwankwo; Vivien Nichols; Kate Seers; Martin Underwood

OBJECTIVES
To evaluate whether a structured online supervised group physical and mental health rehabilitation programme can improve health related quality of life compared with usual care in adults with post-covid-19 condition (long covid).

DESIGN
Pragmatic, multicentre, parallel group, superiority randomised controlled trial.

SETTING
England and Wales, with home based interventions delivered remotely online from a single trial hub.

PARTICIPANTS
585 adults (26-86 years) discharged from NHS hospitals at least three months previously after covid-19 and with ongoing physical and/or mental health sequelae (post-covid-19 condition), randomised (1:1.03) to receive the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) intervention (n=298) or usual care (n=287).

INTERVENTION
Best practice usual care was a single online session of advice and support with a trained practitioner. The REGAIN intervention was delivered online over eight weeks and consisted of weekly home based, live, supervised, group exercise and psychological support sessions.

MAIN OUTCOME MEASURES
The primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months. Secondary outcomes, measured at three, six, and 12 months, included PROMIS subscores (depression, fatigue, sleep disturbance, pain interference, physical function, social roles/activities, and cognitive function), severity of post-traumatic stress disorder, general health, and adverse events.

RESULTS
Between January 2021 and July 2022, 39 697 people were invited to take part in the study and 725 were contacted and eligible. 585 participants were randomised. Mean age was 56 (standard deviation (SD) 12) years, 52% were female participants, mean health related quality of life PROMIS-PROPr score was 0.20 (SD 0.17), and mean time from hospital discharge was 323 (SD 144) days. Compared with usual care, the REGAIN intervention led to improvements in health related quality of life (adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02) at three months, driven predominantly by greater improvements in the PROMIS subscores for depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P<0.001), and pain interference (1.80 (0.50 to 3.11), P=0.01). Effects were sustained at 12 months (0.03 (0.01 to 0.06), P=0.02). Of 21 serious adverse events, only one was possibly related to the REGAIN intervention. In the intervention group, 141 (47%) participants fully adhered to the programme, 117 (39%) partially adhered, and 40 (13%) did not receive the intervention.

CONCLUSIONS
In adults with post-covid-19 condition, an online, home based, supervised, group physical and mental health rehabilitation programme was clinically effective at improving health related quality of life at three and 12 months compared with usual care.

TRIAL REGISTRATION
ISRCTN registry ISRCTN11466448.


Link | PDF (BMJ)
 
The REGAIN trial was a pragmatic, multicentre, parallel group, superiority randomised controlled trial with embedded process evaluation, recruiting throughout England and Wales.
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Hospitalised patients.

Participants were adults (26-86 years) who had been discharged from hospital three or more months previously after hospital admission with covid-19 and who had ongoing substantial (as defined by participants) covid-19 related physical and/or mental health sequelae. In the absence of agreed diagnostic criteria or clinical coding for post-covid-19 condition, participants were asked to self-report any substantial lasting effects that they attributed to their hospital admission with covid-19.
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Unblinded intervention arms.

Participants and practitioners delivering REGAIN could not be masked to group allocation.
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Subjective / self-reported outcomes (excepting mortality, not generally a self-report and usually pretty objective!).

Follow-up outcome assessments were completed by participants online, or, in a small number of cases, over the telephone by a member of the trial team, blind to treatment allocation.
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Outcomes were measured at three, six, and 12 months. The primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) 29+2 Profile v2.1 at three months post-randomisation.
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Our secondary outcomes were dyspnoea (PROMIS dyspnoea severity short form), cognitive function (PROMIS Neuro-QoL short-form v2.0-cognitive function), quality of life (EQ-5D-5L), 15 physical activity (international physical activity questionnaire short-form, IPAQ), 16 severity of post-traumatic stress disorder (impact of events scale-revised, IES-R), 17 anxiety and depression (hospital anxiety and depression scale, HADS), 18 general health (self-report of current overall health compared with baseline), and mortality.
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Adverse events and serious adverse events were recorded in both trial arms, in line with the principles of good clinical practice. 19 Additionally, participants in the intervention group were asked to report any events before each exercise session through a confidential, secure online poll. The trial team routinely reviewed responses and contacted participants for further information as required. As the presentation of postcovid-19 condition and chronic fatigue syndrome/ myalgic encephalomyelitis overlaps, we prospectively monitored for post-exertional symptom exacerbation in the intervention arm during each contact of participants with the intervention team.
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"Full adherence to the REGAIN intervention was defined as attendance at the initial one-to-one session along with completion of four or more of six support sessions and five or more of eight exercise sessions. Partial adherence was defined as attendance at the initial one-to-one session and completion of fewer than four of six support sessions and fewer than five of eight exercise sessions. To assess fidelity to the intervention, we reviewed a randomly selected 5% subsample of video recorded one-to-one sessions and group exercise and support sessions against predetermined checklist criteria. Results of this and the rest of our process evaluation will be reported elsewhere."

"Adherence to the REGAIN intervention was similar to supervised exercise rehabilitation programmes in other clinical conditions.282930 Nearly half (47%) of participants attended the initial one-to-one session in addition to at least four of six support sessions and five of eight exercise sessions (full adherence), which resulted in a measurable effect on the outcome. In the complier average causal effect model compared with the intention-to-treat model, there was a 40% greater difference between groups in favour of the REGAIN intervention at three months. Adherence to rehabilitation interventions is known to affect outcomes, with a dose-response relationship seen for both physical and psychological interventions.2931 The larger effect size observed in the complier average causal effect analysis may relate directly to the greater dose of physical and mental health therapies received, or, alternatively, simply to the greater exposure to other participants with similar experiences. Group interaction is a prominent feature in successful lifestyle interventions."

I saw no evidence of consideration that this, "Adherence to rehabilitation interventions is known to affect outcomes, with a dose-response relationship seen for both physical and psychological interventions.", could actually be showing that for those who do not benefit, or are adversely affected by, the intervention are less likely to adhere to it.
 
And the practical value of this on stamina, physical capacity, employment, welfare use, etc, is...?

The most significant thing about this study is that it avoided any serious measures of these, or any measures at all.

Why do the approval and funding bodies allow it?
 
Only 80% primary outcome data. Minimal significance they decided is 0.03, and they have 0.04. In an open label study with subjective outcomes where the aim is always to influence what people think. With 0.03 at 12 months, and 0.02 at 6. You could not have a smaller effect than this.

Somehow they keep talking about a novel intervention. Good grief I'm sick of this damn marketingspeech where they always pretend that everything they do is both new and tested.

They're stuck in a race to the bottom. This model of trying to squeeze out the smallest bit of significance and laying on it has completely warped the profession's incentive system. They think that the tiniest difference, even a fake one, basically means job done.
 
Gaffney

https://twitter.com/user/status/1755567974008627375


Notable development on the Long Covid front: consistent with previous studies, a randomized trial in ⁦@bmj_latest⁩ found that an exercise-based physical & mental health rehabilitation program improved outcomes for those with Long COVID.

This is hardly a surprising result, but it is newsworthy because some have been making the case that the very intervention found useful in this study amounts to malpractice — claims that have worked their way into clinical guidelines
 
rvallee said:
And this being a physical exercise rehabilitation program, the main benefits should be physical. There aren't any. So what role does exercise even play here?! This is madness.
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I think it’s more likely to be self-interest at the expense of all than madness. But otherwise I salute your astute observation, body and mind. Shame they didn’t look at it the same way huh?
 
Jaybee00 said:
Gaffney

https://twitter.com/user/status/1755567974008627375


Notable development on the Long Covid front: consistent with previous studies, a randomized trial in ⁦@bmj_latest⁩ found that an exercise-based physical & mental health rehabilitation program improved outcomes for those with Long COVID.

This is hardly a surprising result, but it is newsworthy because some have been making the case that the very intervention found useful in this study amounts to malpractice — claims that have worked their way into clinical guidelines
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It is taking a lot of self control not to comment on this thread of nonsense on twitter - mainly as I don't think I can say what I want to say whilst remaining professional.
 
New Scientist
Exercise programme helps people with long covid, but it's no panacea

Article is paywalled but ingress and first few sentences are:

An eight-week virtual exercise programme improved the quality of life of people with long covid, but the effect was relatively modest and it may not benefit everyone with the condition.

For the first time, an exercise-based rehabilitation programme has been found to improve the health of people with long covid.

It might seem like this would be universally welcomed. But it could reopen the long-standing dispute whether people with post-viral fatigue conditions should be encouraged to build up their exercise levels or whether this risks setting them back further.
 
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