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Not yet recruiting NCT06973382

Effects of Pulmonary Rehabilitation on Quality of Life and Health in Pulmonary Arterial Hypertension Patients

No phase Interventional PAH CTEPH

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Pulmonary Rehabilitation Program, Standard Pulmonary Rehabilitation.
Who it may be relevant to
Registry conditions: PAH, CTEPH. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intervention Study of a Comprehensive Pulmonary Rehabilitation Program on Quality of Life and Prognosis in Patients With Pulmonary Arterial Hypertension

Overview

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.

Interventions

  • Behavioral Comprehensive Pulmonary Rehabilitation Program
    Combined Aerobic + Resistance Training Program Mode: Cycle ergometry (stationary bicycle) Frequency: 3-5 sessions per week Program Duration: 12 weeks Session Structure: * 5-minute warm-up * Continuous or interval training (15-30 minutes) * 5-minute cool-downesistance Exercise Component Mode: Dumbbell exercises + cycle ergometry Frequency: 3 sessions per week Program Duration: 12 weeks Session Structure: * 5-minute warm-up * Training session (10-20 minutes) * 5-minute cool-down
  • Behavioral Standard Pulmonary Rehabilitation
    xercise Components: Aerobic Exercise Mode: Walking or jogging Resistance Exercise Mode: Elastic bands or dumbbells Training Parameters: Session Duration: ≥35 minutes (combined aerobic + resistance) Frequency: 3-5 sessions per week Program Duration: 12 weeks

Primary outcome measures

  • 6MWD [Time frame: 12week]

Eligibility 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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06973382 · 2025-KE-62-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗