Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised...

Area of Science:

• Cardiology
• Pulmonology
• Rehabilitation Medicine

Background:

• Supervised cardio-pulmonary rehabilitation shows promise for specific pulmonary hypertension (PH) groups (1 and 4) as inpatients.
• Effectiveness in common PH groups (2, 3, 5), UK outpatient settings, and long-term outcomes remains unevaluated.
• This study addresses the need for evidence in diverse PH populations and community-based settings.

Purpose of the Study:

• To assess the clinical and cost-effectiveness of a supervised exercise rehabilitation program for individuals with pulmonary hypertension (PH).
• To compare the intervention against best practice usual care in a UK National Health Service (NHS) outpatient setting.
• To provide evidence for the routine implementation of supervised exercise rehabilitation for all PH groups.

Main Methods:

• A multi-centre, pragmatic, two-arm randomised controlled trial (RCT) involving 352 adults with PH (WHO functional class II-IV).
• Participants randomized to the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention (8-week supervised exercise, psychosocial support) or usual care.
• Primary outcome: Incremental Shuttle Walk Test at 4 months; secondary outcomes include HRQoL, clinical worsening, and healthcare use. Embedded process evaluation with interviews.

Main Results:

• Primary outcome data (Incremental Shuttle Walk Test at 4 months) is pending.
• Secondary outcome data (HRQoL, time to clinical worsening, healthcare use) is pending.
• Process evaluation data will explore participant and practitioner experiences.

Conclusions:

• The SPHERe study is the first multi-centre RCT in the UK NHS to evaluate supervised exercise rehabilitation for all PH groups.
• Results will inform clinical practice and commissioning decisions regarding the routine provision of exercise rehabilitation for PH patients.
• The study aims to establish the effectiveness and cost-effectiveness of the SPHERe intervention.