SPHERe Patient Information Leaflet v6 (10 May 2022)

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 could take part?

We want to recruit 200 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 did taking part mean?

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?

The study has now closed to new participants. The centres involved in SPHERe were:

• Royal United Hospital, Bath
• Queen Elizabeth Hospital, Birmingham
• University Hospitals Coventry and Warwickshire (UHCW), Coventry
• Broomfield Hospital, Essex
• Hammersmith Hospital, London
• Walsall Healthcare, Walsall
• Golden Jubilee Hospital, Clydebank, Scotland

There were also three Patient Identification Centres (PIC) for the SPHERe trial:

• Sheffield Teaching Hospitals
• University Hospitals of Leicester
• Royal Papworth Hospital, Cambridge

We aim to recruit a minimum of 200 participants.

Exercise capacity measured with Incremental Shuttle Walk Test (ISWT) at four months.