Trial investigates efficacy of online supervised group mental and physical rehabilitation program for long COVID patients

In a recent study published in the BMJ, researchers evaluated the efficacy of an online supervised group mental and physical rehabilitation program in adults with long COVID.

Background

Over 17 million people in the European region of the World Health Organization (WHO) may have experienced coronavirus disease 2019 (COVID-19) symptoms longer than four weeks. Common symptoms of this multisystem condition, known as long COVID or post-COVID-19 condition, include muscle aches, fatigue, dyspnea, and cognitive dysfunction that can profoundly impact quality of life, societal participation, and economic productivity. The pathophysiology of long COVID has not been fully characterized.

As such, current medical management and treatments have limited efficacy. The biopsychosocial care model may improve outcomes for long COVID patients. Multicomponent mental and physical rehabilitation could improve fatigue, quality of life, and breathlessness. So far, few quasi-experimental studies evaluated exercise-based interventions for individuals with long COVID, with no definitive, high-quality evidence.

About the study

In the present study, researchers evaluated the clinical effectiveness of a group rehabilitation program for people with long COVID. The rehabilitation exercise and psychological support after COVID-19 infection (REGAIN) was a multi-center, parallel-group, pragmatic, randomized controlled trial. Participants were recruited in England and Wales. Adults (26-86 years) discharged at least three months after hospitalization with COVID-19 who had ongoing mental and physical sequelae were recruited.

Subjects were excluded if they had severe mental health problems, contraindications to exercise training, or were enrolled in other rehabilitation programs. A baseline questionnaire was administered before randomization to REGAIN or usual care. Usual care participants received the best practice usual care; this involved an online consultation with a trained practitioner, wherein generic advice was provided on recovery and physical activity.

The REGAIN intervention was an eight-week, supervised, home-based, group rehabilitation program, providing online consultation with a REGAIN practitioner. REGAIN participants joined weekly live online group exercise and psychological support sessions. Equipment-free, supervised, personalized exercise sessions were delivered in online groups to improve fatigue, cardiovascular fitness, balance, and strength and restore confidence in daily living activities.

Psychological support sessions were aimed at augmenting psychological capability and increasing COVID-19-related knowledge and its impact on everyday life. The primary outcome of the study was health-related quality of life, determined using the patient-reported outcomes measurement information system (PROMIS). Secondary outcomes included dyspnea, cognitive function, physical activity, anxiety, depression, and general health, among others. Outcomes were assessed at three, six, and 12 months.

Findings

Of over 39,000 people invited to participate between January 2021 and July 2022, 1,043 expressed interest. Following exclusions, 298 and 287 subjects were randomized to REGAIN and usual care, respectively. Most participants were female (52%), White (88%), and obese/overweight (88%). One-third of participants required intensive care during COVID-19 hospitalization.

The average time from discharge to randomization was 323 days. The baseline health-related quality of life was low; around 40% had low physical activity. More than a third of participants could not work due to long COVID. Primary outcome data were available for 80% of REGAIN and 86% of usual care participants. The health-related quality of life improved more for REGAIN participants than usual care recipients at three months.

There was a significant group difference in health-related quality of life, primarily driven by three PROMIS sub-scores – fatigue, depression, and pain interference. While the effect of the intervention was not evident at six months, it was sustained at 12 months. REGAIN participants had increased odds of being more physically active than usual care recipients. At three months, 7% more REGAIN subjects met the physical activity guideline (> 150 minutes of moderate-intensity activity per week).

Furthermore, more REGAIN participants reported feeling much better compared to three months than usual care subjects. Adverse events were reported in both groups. Most serious adverse events were related to hospitalization or extended stay at the hospital. Two adverse events were related to the REGAIN intervention. One serious adverse event was possibly related to the intervention. Post-exertional exacerbation of symptoms was not observed.

Conclusions

In sum, the REGAIN intervention was clinically effective in improving health-related quality of life for adults with post-COVID-19 condition compared to usual care at three months post-randomization. This effect was mainly due to improvements in pain interference, fatigue, and depression. Moreover, the effect was sustained at 12 months. In both groups, there were improvements in the overall quality of life and other well-being indices.