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Effects of Pulmonary Rehabilitation on Quality of Life and Health in Pulmonary Arterial Hypertension Patients (EPRQoL-PAH)

Capital Medical University logo

Capital Medical University

Status

Not yet enrolling

Conditions

CTEPH
PAH

Treatments

Behavioral: Standard Pulmonary Rehabilitation
Behavioral: Comprehensive Pulmonary Rehabilitation Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06973382
2025-KE-62-1

Details and patient eligibility

About

Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC/ERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Confirmed PH Diagnosis:

Right heart catheterization-confirmed pulmonary hypertension

Meets 2022 ESC/ERS Guidelines diagnostic criteria for:

  • Group 1 (PAH) or
  • Group 4 (CTEPH/other pulmonary artery obstructions)

Stabilized Treatment Status:

Group 1 (PAH): Received ≥3 months of targeted drug therapy

Group 4 (CTEPH): Completed ≥6 sessions of BPA* or reached therapeutic endpoint

Functional Capacity:

WHO Functional Class I-III

Age: ≥18 years

Consent: Willing to provide written informed consent -

Exclusion Criteria:Physical Limitations:

Unable to perform pulmonary rehabilitation exercises due to disability or congenital malformations

Cardiopulmonary Testing Contraindications:

Medically unfit to complete CPET (cardiopulmonary exercise testing) after evaluation

Poor Compliance:

History of non-adherence making protocol completion unlikely

Life Expectancy:

Prognosis ≤1 year

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Comprehensive Pulmonary Rehabilitation Program
Experimental group
Treatment:
Behavioral: Comprehensive Pulmonary Rehabilitation Program
Standard Pulmonary Rehabilitation
Active Comparator group
Treatment:
Behavioral: Standard Pulmonary Rehabilitation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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