RecruitingRecruiting
Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients
NCT07149935 · RenJi Hospital
In plain English
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Official title
Continuous Effect Of Long-Term Rehabilitation Training On Clinical Improvement(TTCI) And Cardiopulmonary Function In Pulmonary Arterial Hypertension Patients- A Multicenter-randomisation Study
About this study
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).
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.
Study design
Enrollment target: 104 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-01
Estimated completion: 2026-12
Last updated: 2025-09-02
Interventions
Other: Rehabilitation Training
Primary outcomes
- • 6 minutes walk distance（ 6MWD） (every 3 months, until 6 months)
- • Improved Time To Clinical Improvement(ITTWI) (every 3 months, until 6months)
Sponsor
RenJi Hospital · other
With: Shanghai Pulmonary Hospital, Shanghai, China, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contacts & investigators
ContactJieyan Shen, PhD · contact · shenjieyan@renji.com · 13701864819
InvestigatorJieyan Shen, PhD · study_chair, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
All locations (1)
Renji HospitalRecruiting
Shanghai, Shanghai Municipality, China