Continuous Effect Of Rehabilitation Training On Pulmonary Arterial Hypertension Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rehabilitation Training.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Other 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.
Primary outcome measures
- 6 minutes walk distance（ 6MWD） [Time frame: every 3 months, until 6 months]
- Improved Time To Clinical Improvement(ITTWI) [Time frame: every 3 months, until 6months]
Secondary outcome measures (6)
- Echocardiographic index---right ventricle [Time frame: every 3 months, until 6 months]
- Echocardiographic index---left ventricle [Time frame: every 3 months, until 6 months]
- Echocardiographic index---left ventricle [Time frame: every 3 months, until 6months]
- CPET index [Time frame: every 3 months, until 6months]
- SF-36 score [Time frame: every 3 months, until 6months]
- Echocardiographic index-others [Time frame: every 3 months, until 6months]
Eligibility criteria
Inclusion criteria
- Patients who suffered from pre-capillary PAH (mPAP ≥ 20 mmHg, PVR > 2 Woods unit, PAWP ≤ 15 mmHg) confirmed by right heart catheterisation.
- Patients who are in the status of WHO-FC I-III.
- Patients between 18 and 75 years old
- Female subjects are not pregnant.
- Patients are treated with PAH-targeted drugs and are in a stable state and there is no progress of disease).
- Patients have not received exercise rehabilitation training within six months.
Exclusion criteria
Patients with the following diseases or symptoms:
- Pulmonary vascular occlusive disease
- Respiratory diseases
- Ischaemic heart disease, complex congenital heart disease (e.g., tetralogy of Fallot, etc.), cardiomyopathy, valvular disease
- Active liver disease
- Severe kidney disease
- Motor disorders (e.g. lower limb fracture, ataxia, etc.)
- Malignant tumour diseases
- Physical disability
- Hb ≤ 80g / L
- Systolic blood pressure ≤85mmHg
- History of syncope within 3 months
- History of supraventricular or ventricular arrhythmia at rest within 3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT07149935 · Rehabilitation of PAH