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

NCT06973382 | Not Yet Recruiting DMC

• 1 other identifier: 2025-KE-62-1
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PAH; CTEPH

Outcome Measures

Primary Outcomes (1)

• 6MWD

  12week

Study Arms (2)

Comprehensive Pulmonary Rehabilitation Program

EXPERIMENTAL

Behavioral: Comprehensive Pulmonary Rehabilitation Program

Standard Pulmonary Rehabilitation

ACTIVE COMPARATOR

Behavioral: Standard Pulmonary Rehabilitation

Interventions

Comprehensive Pulmonary Rehabilitation Program BEHAVIORAL

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

Comprehensive Pulmonary Rehabilitation Program

Standard Pulmonary Rehabilitation BEHAVIORAL

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

Standard Pulmonary Rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Beijing Municipal Health Commission: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 15, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share