Condition category
Circulatory System
Date applied
13/03/2019
Date assigned
18/03/2019
Last edited
30/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
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 outpatient service, typically lasting an hour, twice a week for eight weeks. It is not known whether outpatient exercise rehabilitation can help improve the lives of people with pulmonary hypertension. The aim of this study is to find out whether outpatient exercise rehabilitation, combined with psychological and motivational support, can improve fitness and quality of life for people living with pulmonary hypertension, particularly people whose pulmonary hypertension is secondary to heart or lung disease, because exercise rehabilitation has not been researched in these groups. The study will be run in specialist rehabilitation centres by staff experienced in treating people with heart and lung problems.

Who can participate?
Patients with pulmonary hypertension who live near one of at least 10 rehabilitation centres mainly in the East and West Midlands

What does the study involve?
Participants are randomly allocated to supervised exercise with psychological and motivational support, or to continue with usual care (general physical activity advice).The intervention group are invited to complete eight weeks of twice-weekly supervised out-patient exercise rehabilitation. The exercise programme is suitable for people with all types of pulmonary hypertension and can be delivered within existing NHS exercise rehabilitation services. Psychological and motivational support helps reduce anxiety and improve exercise adherence. People in the usual care group receive general physical activity advice, but not supervised exercise. From talking to people with pulmonary hypertension, it is known that the most important benefit of any treatment is reduced breathlessness and fatigue, which would reduce anxiety about daily activities, helping them to 'do more', walk further and have a better quality of life. A walking test and quality of life questionnaires are used over one year to measure if the intervention helps people with pulmonary hypertension, and represents good value for the NHS.

What are the possible benefits and risks of participating?
This study may not offer people any direct benefit, but the results will help people with pulmonary hypertension in the future. If any of the assessments find anything unusual with participants’ health, they will receive prompt and appropriate medical care and attention. Exercise carries a very small risk of complications for people with pulmonary hypertension. If is likely that certain people will have a problem during exercise, their medical team will not ask them to take part. For people who do take part, supervision will be provided by specialist staff. Exercise is likely to cause some tiredness, breathlessness and sore muscles, but this should get a bit easier over time. The researchers do not anticipate any serious risk to participants.

Where is the study run from?
University Hospitals Coventry & Warwickshire NHS Trust (UK)

When is the study starting and how long is it expected to run for?
June 2019 to August 2022

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Gordon McGregor
gordon.mcgregor@uhcw.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gordon McGregor

ORCID ID

http://orcid.org/0000-0001-8963-9107

Contact details

University Hospital
Clifford Bridge Road
Coventry
CV22DX
United Kingdom
+44 (0)2476234570
gordon.mcgregor@uhcw.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

HTA 17/129/02

Study information

Scientific title

Supervised Pulmonary Hypertension Exercise REhabilitation (SPHERe): a multi-centre randomised controlled trial

Acronym

SPHERe

Study hypothesis

The SPHERE intervention will improve clinical and patient-reported outcomes when compared to best practice usual care.

Ethics approval

Approved 13/07/2019, West Midlands - Coventry & Warwickshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44(0)2071048101; nrescommittee.westmidlands-coventryandwarwick@nhs.net), ref: 19/WM/0155

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a particpant information sheet

Condition

Pulmonary hypertension

Intervention

Participants are randomly allocated to either supervised exercise with psychological and motivational support, or to continue with usual care (general physical activity advice).

The intervention group will be invited to complete 8 weeks of twice-weekly supervised outpatient exercise rehabilitation. The researchers have developed an exercise programme suitable for people with all types of pulmonary hypertension that can be delivered within existing NHS exercise rehabilitation services. They 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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Exercise capacity measured with incremental shuttle walk test (ISWT) at 4 months

Secondary outcome measures

1. Exercise capacity measured with incremental shuttle walk test at 12 months
2. Exercise capacity measured with six-minute walk test at 4 and 12 months
3. Disease-specific health-related quality of life (HR-QoL) measured with Cambridge Pulmonary Hypertension Outcome Review at 4 and 12 months
4. Emotional well-being measured with the Hospital Anxiety and Depression Scale at 4 and 12 months
5. Self-efficacy measured with the Generalised self-efficacy scale at 4 and 12 months
6. Fatigue measured with the Fatigue Severity Scale at 4 and 12 months
7. Functional status measured using WHO functional class at 4 and 12 months
8. Medication use measured by self- report case report form at 4 and 12 months
9. Time to clinical worsening measured by medical notes and discussion with clinician at 4 and 12 months
10. Hospital admissions measured with NHS data at 4 and 12 months
11. Adverse events measured with NHS data at 4 and 12 months
12. All-cause mortality measured with NHS data at 4 and 12 months
13. Heath utility measured with EQ-5D-5L at 4 and 12 months
14. Health and care resource use measured by participant self-report and NHS records at 4 and 12 months

Overall trial start date

01/06/2019

Overall trial end date

31/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adults with confirmed PH (groups 1 to 5) as detailed in ESC/ERS guidelines
2. Clinically stable
3. World Health Organisation (WHO) functional class II, III or IV
4. Fluent in spoken English to allow engagement with intervention and physical outcome measures
5. Live within reasonable travelling distance (as defined by the participant) of a SPHERE exercise rehabilitation centre
6. Ability to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

352

Participant exclusion criteria

1. Absolute contra-indications to exercise as per international clinical guidelines
2. PH related complications, or comorbidities severe enough to prevent attendance at a SPHERE centre, or participation in exercise rehabilitation.
3. Any mental health issue that will prevent engagement with study procedures.
4. Unable to make suitable travel arrangements.
5. Previous randomisation in the present trial
6. Pregnancy

Recruitment start date

01/09/2019

Recruitment end date

30/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Coventry & Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry & Warwickshire NHS Trust

Sponsor details

University Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 966195
R&DSponsorship@uhcw.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.uhcw.nhs.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The publication of a trial protocol, trial results and trial data will be in line with the NIHR standard terms: The protocol and other information will be available online here: https://www.journalslibrary.nihr.ac.uk/programmes/hta/1712902/#/

Results of the trial will be prepared by the research team and lay partners, and submitted to funders as a final report. Findings will be submitted to peer-reviewed journals and disseminated to the medical and exercise rehabilitation communities. Papers will be published in open-access journals describing the development of the SPHERe intervention, the trial protocol, and results and data, in accordance with recommended guidance for transparent reporting, the Consolidated Standards of Reporting Trials (CONSORT) guidelines (www.consort-statement.org) and the NIHR standard terms. Abstracts will be submitted to national and international conferences e.g. British Thoracic Society, British Cardiology Society, European Respiratory Society, American College of Cardiology.

The SPHERe intervention will be fully manualised and available for public access once the trial has been completed. If appropriate, a practitioner training programme will be developed to support the implementation of SPHERe.

If the SPHERe intervention is successful, work will be undertaken with national governing bodies (BACPR, BTS), charities (PHA-UK, BHF, BLF) and service audit providers (National Audit of Cardiac Rehabilitation [NACR], National Asthma and COPD Audit Programme [NACAP], NHS Digital PH audit), to promote the inclusion of people with PH in cardio-pulmonary rehabilitation programmes.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request after publication of the main study results. Requests for data sharing will be managed in accordance with University of Warwick policy on data sharing.

Intention to publish date

31/08/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/07/2019: The ethics approval was added. 18/03/2019: Trial's existence confirmed by the NIHR HTA.