Exercise-based Rehabilitation in Patients With Pulmonary Arterial Hypertension

NCT06804122 | Recruiting

• 1 other identifier: R24101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

Pulmonary Arterial Hypertension; Exercise-based rehabilitation; Intervention

Outcome Measures

Primary Outcomes (1)

• Change in six-minute walking test result

  Each participant performs a six-minute walking test at baseline (before exercise-based intervention) and after the intervention that lasts 12 weeks.

  12 weeks

Study Arms (1)

Exercise-based outpatient rehabiliation

EXPERIMENTAL

All patients are allocated to this treatement arm where they are provided with structured guidance for implementation of exercise rehabiliation in an out-patient setting.

Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION BEHAVIORAL

Patients are counseled how to do endurance training and strenght training at home by a trained physiotherapist.

Exercise-based outpatient rehabiliation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere Heart Hospital: lead
• Tampere University Hospital: collaborator
• Tampere University: collaborator

Study Sites (1)

Tampere Heart Hospital

Tampere, Pirkanmaa, 33300, Finland

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Exercise; Dosage Forms

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Jussi A Hernesniemi, MD PhD

  Tampere Heart Hospital

  STUDY CHAIR

Central Study Contacts

Pauliina Leskelä, MD

CONTACT

+3583311611; pauliina.leskela@sydansairaala.fi

Jussi A Hernesniemi, MD PhD

CONTACT

+3583311611; jussi.hernesniemi@sydansairaala.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exercise-based out-patients intervention is implemented to all particitpants who will undergo rehabiliation for pulmonary arterial hypertension

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: January 27, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)