Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients

NCT ID: NCT07149935

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-12-31

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).

Conditions

Pulmonary Hypertension

Study Design

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

Study Groups

rehabilitation training

open label

Group Type: EXPERIMENTAL

Rehabilitation Training

Intervention Type: OTHER

The rehabilitation training has two parts: the exercise training at home（5 times per week, as well as the Inspiratory muscle training(once per day) including Respiratory trainer exercise and abdominal breathing training.

control

open label

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rehabilitation Training

The rehabilitation training has two parts: the exercise training at home（5 times per week, as well as the Inspiratory muscle training(once per day) including Respiratory trainer exercise and abdominal breathing training.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jieyan Shen, PhD

Role: STUDY_CHAIR

Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jieyan Shen, PhD

Role: CONTACT

shenjieyan@renji.com

13701864819 ext. +86

Facility Contacts

Jun Tong, postgra

Role: primary

tj0129@sjtu.edu.cn

19121913396

Other Identifiers

Rehabilitation of PAH

Identifier Type: -

Identifier Source: org_study_id