Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients

Not Applicable

Recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT07149935
• Lead Sponsor: RenJi Hospital

Brief Summary

This multicenter, open label, double-arm study aims at investigating the the continuous effect of long-Term rehabilitation training on clinical improvement(ITTCI) and cardiopulmonary function in pulmonary arterial hypertension patients

Detailed Description

Pulmonary Arterial Hypertension (PAH) is a disease caused by various reasons leading to pulmonary vascular remodelling and then results in a progressive increase in pulmonary vascular resistance and right heart failure. PAH progresses rapidly,with a poor prognosis. Targeted drugs has brought about an improvement in the quality of life of patients with PAH. However, in most cases, patients' clinical symptoms will be gradually worsen with exercise capacity gradually declining. The prognosis of PAH remains bleak. Although exercise was previously considered as a relative contraindication for PAH patients , a growing body of research has found that exercise rehabilitation is safe and effective for them. Patients show greater improvement in their symptoms and quality of life. Effective and appropriate exercise rehabilitation in low- and middle-income countries can maximise the therapeutic benefits of targeted medication, improve patient survival rate, and enhance exercise tolerance and cardiorespiratory fitness. In this study, we will investigate the continuous effects of exercise rehabilitation on the clinical improvement (time to clinical improvement, TTCI) and cardiorespiratory fitness over a 1-year period of long-term rehabilitation, including aerobic training (aerobic power cycling and treadmill walking) and inspiratory muscle training (respiratory trainer and lip-contracting abdominal breathing).

Study Timeline

• Study First Submitted: 2024-06-05
• Study Start: 2024-09-01
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-24
• Last Update Submitted: 2025-08-24
• Study First Posted: 2025-09-02
• Last Update Posted: 2025-09-02
• Primary Completion: 2026-06
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Patients who suffered from pre-capillary PAH (mPAP ≥ 20 mmHg, PVR > 2 Woods unit, PAWP ≤ 15 mmHg) confirmed by right heart catheterisation.
2. Patients who are in the status of WHO-FC I-III.
3. Patients between 18 and 75 years old
4. Female subjects are not pregnant.
5. Patients are treated with PAH-targeted drugs and are in a stable state and there is no progress of disease).
6. Patients have not received exercise rehabilitation training within six months.

Exclusion Criteria

Patients with the following diseases or symptoms:

1. Pulmonary vascular occlusive disease
2. Respiratory diseases
3. Ischaemic heart disease, complex congenital heart disease (e.g., tetralogy of Fallot, etc.), cardiomyopathy, valvular disease
4. Active liver disease
5. Severe kidney disease
6. Motor disorders (e.g. lower limb fracture, ataxia, etc.)
7. Malignant tumour diseases
8. Physical disability
9. Hb ≤ 80g / L
10. Systolic blood pressure ≤85mmHg
11. History of syncope within 3 months
12. History of supraventricular or ventricular arrhythmia at rest within 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
6 minutes walk distance（ 6MWD）	every 3 months, until 6 months	The walk distance of patients in 6 minutes
Improved Time To Clinical Improvement(ITTWI)	every 3 months, until 6months	The time that required from the time of rehabilitation training to the first occurrence of at least one stratum improvement of the weber classification

Secondary Outcome Measures

Name	Time	Method
Echocardiographic index---right ventricle	every 3 months, until 6 months	TAPSE, right ventricular diameter, tricuspid annular systolic motion s'
Echocardiographic index---left ventricle	every 3 months, until 6months	TAPSE/PASP
CPET index	every 3 months, until 6months	AT, VE/VCO2 slope, PetCO2, oxygen pulse (VO2/HR), peak oxygen uptake (peak VO2),VE/VO2,PetO2
SF-36 score	every 3 months, until 6months	SF-36 is a scale for evaluating the life quality of PAH patients
Echocardiographic index-others	every 3 months, until 6months	RVFAC（right ventricle fraction of area changes）, diameter of pulmonary artery

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai Municipality, China