Long-term rehabilitation training for people with pulmonary arterial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, two-arm interventional study that delivers a year of long-term rehabilitation including aerobic exercise (cycling and treadmill) and inspiratory muscle training. Participants are adults with pre-capillary pulmonary arterial hypertension who are WHO functional class I–III and are on stable targeted PAH therapy. The study measures time to clinical improvement (TTCI) and changes in cardiopulmonary function over 12 months. Outcome comparisons will be made between the two arms to determine the continuous effects of rehabilitation on symptoms, exercise tolerance, and cardiorespiratory fitness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jieyan Shen, PhD
• Email: shenjieyan@renji.com
• Phone: 13701864819

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.