NCT06804122 Exercise-based Rehabilitation in Patients With Pulmonary Arterial Hypertension
| NCT ID | NCT06804122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere Heart Hospital |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-01-27 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pulmonary arterial hypertension (PAH) is a rare and severe disease characterized by elevation of pulmonary artery pressure (PAP) and increased pulmonary vascular resistance (PVR) due to the narrowing of small pulmonary arteries. The European Society of Cardiology (ESC) and the European Respiratory Society (ERS) recommend supervised exercise-based rehabilitation as part of the treatment of PAH patients alongside optimal medical therapy (Level of evidence A, Class of recommendation I). Studies on exercise-based rehabilitation for PAH patients are limited, and most interventions have been conducted at least partially in hospital settings. Unlike more common cardiovascular diseases, there are no detailed international exercise guidelines tailored specifically for PAH patients. This study aims to verify that a group-based outpatient rehabilitation protocol suitable for the Finnish healthcare system improves exercise capacity, quality of life, and physical activity of PAH patients and is safe for appropriately selected patients. Additionally, the study aims to determine whether PAH patients adhere to regular exercise training and whether physical activity increases in the long term. The goal is to assess whether an outpatient rehabilitation protocol, designed for the Finnish healthcare system, can achieve similar results to those observed in previous international studies. The primary outcome measure is the change in the six-minute walking distance (6MWD) compared to the patient's baseline. Long-term 6MWD data are often available for patients. The 6MWD is the most commonly used primary outcome in randomized and controlled PAH drug trials, and improvements in this test have been the basis for drug approvals. An improvement of 33 meters in the 6MWD is considered clinically significant, and the goal is to achieve this change with group-based outpatient rehabilitation. Secondary outcomes include changes in quality of life (SF-36), WHO functional class, NT-proBNP levels, echocardiographic parameters, ESC/ERS risk-stratification score (four-strata model), muscle strength, respiratory measures, balance, daily step count, and insomnia severity.
Eligibility Criteria
Inclusion Criteria: * Adults over 18 years old residing in Tampere or nearby municipalities. * WHO functional classification II-III. * Commitment to the exercise program. * Stable disease condition with no PAH medication changes in the two months prior. * No recent syncope or arrhythmias causing symptoms within the past two months. Exclusion Criteria: * Severe pulmonary disease or left ventricular failure (HFrEF). * Pregnancy. * Severe congenital heart defect (Eisenmenger syndrome). * Severe liver disease. * Acute inflammatory condition. * Severe anemia (hemoglobin ≤ 75% of the lower reference limit). * Systolic blood pressure below 85 mmHg. * Recent syncope. * Other significant conditions affecting physical capacity, such as severe neurological diseases or musculoskeletal issues. * Untreated severe arrhythmias. * Changes in PAH medication during the rehabilitation program.
Contact & Investigator
Jussi A Hernesniemi, MD PhD
STUDY CHAIR
Tampere Heart Hospital
Frequently Asked Questions
Who can join the NCT06804122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06804122 currently recruiting?
Yes, NCT06804122 is actively recruiting participants. Contact the research team at pauliina.leskela@sydansairaala.fi for enrollment information.
Where is the NCT06804122 trial being conducted?
This trial is being conducted at Tampere, Finland.
Who is sponsoring the NCT06804122 clinical trial?
NCT06804122 is sponsored by Tampere Heart Hospital. The principal investigator is Jussi A Hernesniemi, MD PhD at Tampere Heart Hospital. The trial plans to enroll 20 participants.