People with pulmonary hypertension are being offered an eight-week programme of supervised exercise and psychological support to see if it can help them breathe more easily and feel less anxious. This matters because pulmonary hypertension—stiff, narrowed blood vessels in the lungs—leaves many patients breathless, fatigued, and afraid to move. Current drug treatments help symptoms, but no one knows whether structured exercise rehabilitation is safe or effective for the most common types of the disease (those caused by left heart disease, lung disease, or other disorders). Previous trials only tested exercise in hospital for two rarer forms. If the SPHERe trial shows benefit, the NHS could offer out-patient exercise rehabilitation as a standard treatment for all five types of pulmonary hypertension. That would give patients a practical, non-drug option to improve their daily stamina, mood, and quality of life—without needing to travel to a specialist hospital. The trial also tracks costs, hospital admissions, and long-term outcomes over five years, so funders will know whether the programme is worth scaling up.
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Why is this important? 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. Background: Pulmonary hypertension (PH) is a debilitating condition, causing dyspnoea, fatigue, dizziness, and chest pain. Many affected people are anxious about, and avoid, physical activity. Depression is common, and quality of life can be poor. Supervised exercise rehabilitation may be safe and beneficial for people with PH groups 1 (pulmonary vascular disease) and 4 (chronic thromboembolic disease), particularly as an in-patient. It has not been tested in the most common groups; group 2 (left heart disease) and group 3 (lung disease), or group 5 (miscellaneous disorders); and has not been evaluated in an NHS out-patient setting, or with long-term follow-up. Design/setting: Stage 1: pre-pilot with 6-10 participants at 3 centers, to confirm feasibility. Stage 2: 6-month internal pilot (n=60) to confirm recruitment and retention at multiple centres. Stage 3: multi-centre, two-arm RCT with parallel process evaluation and 1.15:1 treatment allocation, randomised by minimisation based on PH group, WHO functional class, and centre (11 NHS out-patient centres in the East and West Midlands). Population: Adults with confirmed PH diagnosis (groups 1-5) as per ESC/ERS guidelines, WHO functional class II-IV, and clinically stable. Exclusion: unable/unsafe to exercise or travel to a treatment centre, PH related hospital admission in last 4 weeks. Health technology: The 8-week Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention, developed through systematic literature review, expert opinion, stakeholder consensus, and component piloting. SPHERe includes: 1) individual assessment and familiarisation sessions; 2) supervised out-patient exercise programme; 3) psychosocial/motivational support and education; 4) guided home exercise plan. Control: Best practice usual care with a one-to-one practitioner appointment, and general advice on safe and effective physical activity. Primary outcome: Incremental Shuttle Walk Test at 4 months. Measured by researchers blinded to treatment allocation at baseline, 4 months (post-intervention) and 12 months. Secondary outcomes: exercise capacity, quality of life, health utility, anxiety/depression, self-efficacy, fatigue, WHO functional class, medication use, time to clinical worsening, health and social care use, all-cause hospital admissions and mortality, adverse events. Sample size: Allowing for 20% loss to follow-up, 352 participants are required to achieve 90% power at 5% significance level; based on a SMD of 0.5 (45m in 6MWT), an ICC of 0.03, and an intervention group cluster size of 12 at follow-up. Analysis. Primary: overall treatment effect for all PH diagnostic groups. Secondary: pooled effects for groups 2 and 3. We will use intention-to-treat analyses and hierarchical linear regression models to estimate treatment effects (95% confidence intervals), adjusted for patient-level covariates and centre effect. Prospective cost-effectiveness will be assessed as incremental cost per QALY estimates and credible intervals, cost-effectiveness acceptability curve and value-of-information analyses. Team: Lay partners, clinical academic exercise physiology, physiotherapy, health psychology, secondary care medicine (cardiology and respiratory), general practice, statistics, health economics, clinical trialists. Timeline (month): Set-up, pre-pilot and internal pilot (0-9); recruitment (4-23); primary outcome follow-up (8-27); 12-month follow-up (16-35) analysis/dissemination (35-39); 5-year follow-up (27-83).
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