Development of a Complex Exercise Rehabilitation Intervention for People with Pulmonary Hypertension: The Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) Trial

Abstract

Background: People with pulmonary hypertension (PH) are not routinely referred for exercise rehabilitation despite the potential for reducing breathlessness and improving quality of life. We describe the development of a supervised exercise-based rehabilitation programme for this group. The intervention will be tested in a randomised controlled trial (Supervised Pulmonary Hypertension Exercise Rehabilitation trial: SPHERe).Methods: Work was completed in three phases; 1) systematic review, 2) stakeholder engagement with consensus from expert opinion, and 3) intervention piloting and acceptability testing. Our systematic reviews identified exercise interventions for pulmonary hypertension. The draft intervention was ratified through discussions with representatives from medicine, exercise physiology, psychology, and patients. We subsequently assessed the SPHERe intervention in a pre-pilot. Results: Systematic reviews report that exercise might be safe and effective in this population. We found that other exercise interventions were within existing international cardiopulmonary rehabilitation guidelines. Stakeholder opinion and consensus shaped components of the SPHERe intervention, including addition of individual behavioural education sessions to promote adherence to exercise. Our pre-pilot investigation identified a number of condition-specific issues relating to safety and fear avoidance. We addressed these by adding two familiarisation sessions. The development of comprehensive intervention training manuals for participants and practitioners will ensure standardised delivery.Discussion: The SPHERe intervention incorporates three main components: supervised gym exercise, behavioural strategies to encourage adherence, and a home exercise plan for people with pulmonary hypertension. We will evaluate the clinical and cost-effectiveness of the SPHERe intervention in a multicentre randomised controlled trial for people with pulmonary hypertension (ISCRTN no.:10608766)