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SPHERe

Hospital ward

*****Trial updates******

Due to the current situation with COVID-19, this study has been suspended until further notice.

Key information

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

Summary:

What is pulmonary hypertension and how is it treated?
Pulmonary hypertension is a disabling long-term condition that can greatly reduce quality of life. Blood vessels supplying the lungs become thick and stiff, restricting blood flow. Blood pressure is increased in these vessels meaning the heart must work harder to pump blood to the lungs. Over time, the heart may begin to fail. Breathlessness, fatigue and dizziness are the most common symptoms. People with pulmonary hypertension are often anxious about carrying out normal daily activities. There are five types of pulmonary hypertension with different causes. Medical treatment is different for each type, and may help to improve symptoms. Little is known about whether exercise rehabilitation may help people living with pulmonary hypertension.

Supervised exercise rehabilitation is a common treatment for many heart and lung conditions. It can improve fitness, breathlessness, anxiety, depression, and quality of life. Some research has shown that exercise rehabilitation may be helpful for people with certain types of pulmonary hypertension: pulmonary arterial hypertension, and pulmonary hypertension due to blood clots in the lungs. Most of these exercise programmes included three weeks of intensive exercise as a hospital in-patient. This is not feasible in the NHS, where exercise rehabilitation is an out-patient service, typically lasting an hour, twice a week for eight weeks. We do not know if out-patient exercise rehabilitation can help improve the lives of people with pulmonary hypertension.

What are we trying to find out?
We want to know if out-patient exercise rehabilitation, combined with psychological and motivational support, can improve fitness and quality of life for people living with pulmonary hypertension. We are particularly interested in people whose pulmonary hypertension is secondary to heart or lung disease, because exercise rehabilitation has not been researched in these groups. We will recruit 350 people with pulmonary hypertension in the East and West Midlands who agree to be randomly allocated to supervised exercise with psychological and motivational support, or to continue with usual care (general physical activity advice).


What treatments are we testing?
The intervention group will be invited to complete eight weeks of twice-weekly supervised out-patient exercise rehabilitation. We have developed an exercise programme suitable for people with all types of pulmonary hypertension that can be delivered within existing NHS exercise rehabilitation services. We have tested, evaluated, and refined this over a six-month period. The study will be run in specialist rehabilitation centres by staff experienced in treating people with heart and lung problems. Psychological and motivational support will help reduce anxiety and improve exercise adherence. People in the usual care group will receive general physical activity advice, but not supervised exercise.


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 reduced breathlessness and fatigue. People have told us that this would reduce anxiety about daily activities, helping them to 'do more', walk further and have a better quality of life. We will use a walking test and quality of life questionnaires over one year to measure if our intervention helps people with pulmonary hypertension, and represents good value for the NHS.

Sample size:

We aim to recruit a minimum of 352 participants

Duration:

The trial will start on 1st Jun 2019 and end on 31 Aug 2022

Primary outcome:

Incremental shuttle walk test at four months

SPHERe logo


Enquiries:

If you have any questions about the SPHERe trial, please contact the trial team who will be happy to answer them.

Telephone: 02476 151 343
Email: SPHERE@warwick.ac.uk


The SPHERe Team:

Chief Investigator

Dr Gordon McGregor

Research Fellow

Stuart Ennis

Senior Project Manager

Jessica Smith

Trial Manager

Sharisse Alleyne

Trial Coordinator

Juwairia Sajid