What will be investigated
Researchers at the University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) NHS Trust will be investigating whether a tailored online exercise and support programme would benefit those experiencing long-term symptoms of Covid-19 – what has been dubbed ‘long Covid’.
Little is currently known about the long-term effects of Covid-19. While most people will gradually get better on their own, others will have persistent mental and physical health problems. When the trial was first proposed there was no term for these long-term effects. This post-COVID syndrome has since been informally dubbed ‘long Covid’, but there is no specific definition for the term.
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.
The National Institute for Health Research announced there will be funding of £1.19 million for this trial to take place. This study will be part of its Recovery and Learning call, to help better manage current and future waves of the COVID-19 pandemic and investigate its long-term impacts on the health and care system beyond the acute phase.
About the trial
The trial will focus on people who have had a hospital admission for Covid-19 and who are still suffering with any physical or mental health problems more than three months after their discharge from hospital. They are specifically looking for those people who are still experiencing the following symptoms:
- Low fitness/energy
- Sleeping problems
- Worry or anxiety
- Low mood or frustration
- Shoulder or back pain
- Memory or concentration problems
- A persistent cough
This will be a randomised controlled trial aiming to recruit 535 people. Participants will be randomised to one of two groups: one group will take part in an eight-week programme of online group exercise and support sessions, the other will receive a single on-line session of exercise advice and support. Due to social distancing restrictions, the trial will be conducted entirely online.
For those undertaking the exercise and support programme, they will have a live video exercise session once a week with an instructor in groups of up to ten. These sessions will be tailored to suit the abilities and fitness levels of those taking part, using a range of different cardiovascular and muscle strength exercises without equipment. They will also take part in an online 45 minute group support session once a week with their exercise group and specialist.
In addition, participants will be encouraged to undertake two optional on-demand sessions per week, ranging from activities as gentle as breathing exercises and Pilates up to more moderate intensity sessions. Rather than aiming to challenge themselves, participants will be directed to activities that they are comfortable with.
How the trial will be measured
Participants will be surveyed when they begin the trial on aspects of their quality of life, anxiety, depression, breathlessness, cognitive function, physical activity, PTSD, as well as details of their personal and work lives. Follow up surveys at 3 months, 6 months and 12 months after beginning the programme will allow the researchers to determine whether there is any difference between the 8 week programme or single session of advice and support, in how people feel. There will also be an economic analysis of the programme to determine whether the treatments are cost-effective.
Dr Gordon McGregor, a Clinical Exercise Physiologist, is Chief Investigator for this trial at Warwick Clinical Trials Unit and UHCW NHS Trust.
Dr McGregor said:
"The main aim of the 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.
The sessions are very much geared towards encouraging people to engage in all kinds of activities. Our exercise specialists are very skilled and experienced and will be able to deliver sessions for a wide range of abilities. It’s very likely that we will have participants with very different capabilities, so we will be carefully tailoring the exercise and the specialist will coach them accordingly.”
While there is limited research into the long-term effects of Covid-19, there is some previous evidence from similar diseases such as SARS that patients can benefit from structured exercise rehabilitation. Other conditions where patients experience breathlessness can also benefit from exercise rehabilitation.
Little previous research has examined an exercise programme delivered entirely online, where participants are also remotely supervised. While the format is similar to popular exercise programmes that many gyms, leisure centre and fitness trainers have been live-streaming since the start of the pandemic, the 'REGAIN' trial programme will be specifically tailored to the requirements of those with the symptoms of long Covid with direct supervision by exercise specialists. General advice on exercising when recovering from Covid-19 here.
Dr McGregor added:
“There’s some evidence to suggest exercise rehabilitation may help this group of patients, but we need to properly test this as it’s still uncharted territory. With so many unknowns about Covid-19, it’s important that we robustly investigate potential treatments so we can know with confidence whether they have a benefit for patients, or not.
Long Covid’ has had a huge impact on society in the UK and that’s becoming more apparent. We don’t really know how many people are suffering with this but it is likely to be in the thousands and there is no formal, structured support in place at the moment. We hope that a programme of exercise and support will help people improve their quality of life, but it may not. We need to test this first to see if it is beneficial.”
Lord Bethell, Minister for Innovation, said:
“COVID-19 is an awful disease and we are determined to beat it. That’s why I am so excited that NIHR is investing a further £5.5m to unlock the mysteries of this dreadful contagion.”