Supervised Pulmonary Hypertension Exercise REhabilitation (SPHERe) trial

Not Applicable

• Conditions: Pulmonary hypertension; Circulatory System; Primary pulmonary hypertension

• Registration Number: ISRCTN10608766
• Lead Sponsor: niversity Hospitals Coventry & Warwickshire NHS Trust

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32429969/ protocol (added 26/05/2020) 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39033102/ Protocol update (added 22/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Last Update Posted: 5 August 2024
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Current inclusion criteria as of 29/03/2021:
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 (outcome assessments only)
6. Ability to provide informed consent
7. Access to appropriate IT infrastructure (computer, laptop, tablet, smart phone, email and internet connection)
8. Ability to make suitable travel arrangements to attend clinic (outcome assessments only)

Previous 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

Exclusion Criteria

Current exclusion criteria as of 29/03/2021:
1. Absolute contraindications 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. Previous randomisation in the present trial
5. Pregnancy at the time of recruitment

Previous exclusion criteria:
1. Absolute contraindications 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exercise capacity measured with incremental shuttle walk test (ISWT) at 4 months.