We have now re-opened following a pause to recruitment during the COVID-19 pandemic.
Title: Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) Trial
Chief Investigator: Dr Gordon McGregor
Sponsor: University Hospitals Coventry & Warwickshire NHS Trust
Funder: NIHR Health Technology Assessment Programme
Registration Number: ISRCTN 10608766
What is pulmonary hypertension?
Pulmonary hypertension is a long-term condition where blood vessels supplying the lungs can become thick and stiff. This can restrict blood flow. Blood pressure is increased in these vessels meaning the heart must work harder to pump blood to the lungs. Breathlessness, fatigue and dizziness are the most common symptoms. People with pulmonary hypertension are often worried about carrying out normal daily activities and this can impact on people’s quality of life.
How is the condition treated?
There are five types of pulmonary hypertension, each with different causes and medical treatments. This can include drugs to thin the blood, that may help improve symptoms. A common treatment for other heart and lung conditions is exercise rehabilitation – it has shown to improve fitness, breathlessness, anxiety, depression and quality of life. But it is not known if exercise rehabilitation can help people living with pulmonary hypertension.
What research has been done already?
Some research has found that exercise rehabilitation may be helpful for people with certain types of pulmonary hypertension. But these studies looked at giving exercise to people, under supervision, whilst they were in hospital. No research has looked at whether we can prescribe exercise outside of the hospital setting, for people living with pulmonary hypertension in the community.
What are we trying to find out?
We want to find out if exercise rehabilitation can be done at home with online (remote) supervision from trained exercise specialists. We have developed a new exercise programme, with motivational support, to encourage people to exercise for eight weeks. We now want to find out if this programme is better than usual NHS care for people with pulmonary hypertension.
Who can take part?
We want to recruit 352 people with pulmonary hypertension from anywhere in the UK. We will screen people to find out if they can take part e.g. have access to the internet. We will allocate people randomly (using a computer) into two treatment groups: 1) group 1 will be invited to take part in the remote supervised exercise programme for eight weeks and 2) group 2 will receive general advice on physical activity, which is usual NHS care.
What treatments are we testing?
People in group 1 will be invited to take part in remote, supervised, online group exercise sessions, once a week. A home exercise bike will also be loaned out for people to use twice a week, at their own pace. Weekly motivational support sessions will help to encourage people to stick to their exercise plan. This programme will last for eight weeks.
People in group 2, the usual care group, will receive one online appointment with an exercise specialist, to talk about their lifestyle and keeping active. People in group 2 will not take part in the exercise programme.
What will it mean if I take part?
We will ask everyone to do a 10-minute walking test and fill out questionnaires at three different time points – when you join, at four months and after one year. We want to find out about your symptoms and quality of life. Your answers will help us work out if the new programme represents good value for the NHS.
How will we know if the treatment helps?
From talking to people with pulmonary hypertension, we know that the most important benefit of any treatment is helping to reduce breathlessness and fatigue. People have told us that this would help them with confidence to do daily activities, to 'do more', to walk further and have a better quality of life. We want to improve the fitness and quality of life of those living with pulmonary hypertension.
How do I take part?
If your nearest hospital is taking part, and you seem to be eligible, you may receive an invitation pack in the post. Currently SPHERe is open at:
- University Hospitals Coventry and Warwickshire (UHCW)
- Walsall Healthcare
- Sheffield Teaching Hospitals.
If you are not usually treated at one of the hospitals above but are willing to travel to the one of them for your assessments, please contact us directly on email@example.com or 02476 150 300.
We aim to recruit a minimum of 352 participants.
Exercise capacity measured with Incremental Shuttle Walk Test (ISWT) at four months.
If you have any questions about the SPHERe trial, please contact the trial team who will be happy to answer them.
Telephone: 02476 150 300
The SPHERe Team:
Dr Gordon McGregor
Senior Project Manager