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
Authors: McGregor Gordon , Sandhu Harbinder , Bruce Julie , Sheehan Bartholomew , McWilliams David , Yeung Joyce , Jones Christina , Lara Beatriz , Alleyne Sharisse , Smith Jessica , Lall Ranjit , Ji Chen , Ratna Mariam , Ennis Stuart , Heine Peter , Patel Shilpa , Abraham Charles , Mason James , Nwankwo Henry , Nichols Vivien , Seers Kate , Underwood Martin 
Published: February 2024

Abstract

Objective
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).

Interventions
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 registryISRCTN11466448.