Continuous Effect Of Long-Term Rehabilitation Training On Clinical Improvement(TTCI) And Cardiopulmonary Function In Pulmonary Arterial Hypertension Patients- A Multicenter-randomisation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 6 minutes walk distance( 6MWD)
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Because the specificity of rehabilization, it is not suitable for us to mask
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
rehabilitation training
open label
干预措施: Rehabilitation Training (Other)
control
open label
结局指标
主要结局
6 minutes walk distance( 6MWD)
时间窗: every 3 months, until 6 months
The walk distance of patients in 6 minutes
Improved Time To Clinical Improvement(ITTWI)
时间窗: every 3 months, until 6months
The time that required from the time of rehabilitation training to the first occurrence of at least one stratum improvement of the weber classification
次要结局
- SF-36 score(every 3 months, until 6months)
- Echocardiographic index---right ventricle(every 3 months, until 6 months)
- Echocardiographic index---left ventricle(every 3 months, until 6months)
- CPET index(every 3 months, until 6months)
- Echocardiographic index-others(every 3 months, until 6months)
- Echocardiographic index---left ventricle(every 3 months, until 6 months)
