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临床试验/NCT07149935
NCT07149935招募中不适用

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

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

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

Experimental

open label

干预措施: Rehabilitation Training (Other)

control

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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