Long-term rehabilitation training for people with pulmonary arterial hypertension

Continuous Effect Of Long-Term Rehabilitation Training On Clinical Improvement(TTCI) And Cardiopulmonary Function In Pulmonary Arterial Hypertension Patients- A Multicenter-randomisation Study

This program will test whether a year of aerobic and breathing rehabilitation helps adults with pulmonary arterial hypertension improve symptoms and heart-lung fitness while on stable medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07149935 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with confirmed pre-capillary PAH (mPAP ≥20 mmHg, PVR >2 WU, PAWP ≤15 mmHg), WHO-FC I–III, on stable PAH-targeted drugs and without recent exercise rehabilitation are ideal candidates.

Not a fit: People with WHO functional class IV disease, significant respiratory or ischemic heart disease, active severe organ dysfunction, recent syncope, major motor disability, or other listed exclusions are unlikely to benefit from this rehabilitation program.

Why it matters

Potential benefit: If successful, the program could improve exercise tolerance, symptoms, and overall cardiorespiratory fitness for people with PAH.

How similar studies have performed: Previous studies have shown that supervised exercise rehabilitation can be safe and can improve symptoms and quality of life in PAH, though long-term continuous effects remain less well characterized.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jieyan Shen, PhD

Conditions Pulmonary Hypertension; Rehabilitation, Pumonary arterial hypertension