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

NCT ID: NCT06973382

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2027-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Comprehensive Pulmonary Rehabilitation Program

Group Type: EXPERIMENTAL

Comprehensive Pulmonary Rehabilitation Program

Intervention Type: 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

Standard Pulmonary Rehabilitation

Group Type: ACTIVE_COMPARATOR

Standard Pulmonary Rehabilitation

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Health Commission

OTHER_GOV

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-KE-62-1

Identifier Type: -

Identifier Source: org_study_id