Effects of Exercise-based Rehabilitation on Exercise Capacity, Quality of Life and Physical Activity in Patients With Pulmonary Artery Disease

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Finland
Tampere Heart Hospital
RECRUITING
Tampere
Contact Information
Primary
Pauliina Leskelä, MD
pauliina.leskela@sydansairaala.fi
+3583311611
Backup
Jussi A Hernesniemi, MD PhD
jussi.hernesniemi@sydansairaala.fi
+3583311611
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Exercise-based outpatient rehabiliation
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.
Related Therapeutic Areas
Sponsors
Leads: Tampere Heart Hospital
Collaborators: Tampere University Hospital, Tampere University

This content was sourced from clinicaltrials.gov