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临床试验/NCT06973382
NCT06973382尚未招募不适用

Intervention Study of a Comprehensive Pulmonary Rehabilitation Program on Quality of Life and Prognosis in Patients With Pulmonary Arterial Hypertension

Beijing Chao Yang Hospital0 个研究点目标入组 84 人开始时间: 2025年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
主要终点
6MWD

研究概览

简要总结

Pulmonary hypertension (PH) is a major global health concern, affecting approximately 1% of the world's population. With global aging and increased life expectancy, its incidence continues to rise. PH is a progressive and disabling disease, with studies showing its progression correlates with worsening symptoms and increased mortality. Even with targeted medications, the prognosis remains poor across PH subtypes, with PAH patients showing only a 49% 7-year survival rate. The 2022 ESC/ERS guidelines emphasize that PH management requires a comprehensive, multidisciplinary approach. Beyond pharmacological and surgical treatments, rehabilitation has demonstrated benefits in improving exercise capacity, quality of life, functional class, and peak oxygen consumption. However, research on specific and effective comprehensive pulmonary rehabilitation programs remains lacking.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed PH Diagnosis:
  • Right heart catheterization-confirmed pulmonary hypertension
  • Meets 2022 ESC/ERS Guidelines diagnostic criteria for:
  • Group 1 (PAH) or
  • Group 4 (CTEPH/other pulmonary artery obstructions)
  • Stabilized Treatment Status:
  • Group 1 (PAH): Received ≥3 months of targeted drug therapy
  • Group 4 (CTEPH): Completed ≥6 sessions of BPA* or reached therapeutic endpoint
  • Functional Capacity:
  • WHO Functional Class I-III
  • Age: ≥18 years
  • Consent: Willing to provide written informed consent -

排除标准

  • Physical Limitations:
  • Unable to perform pulmonary rehabilitation exercises due to disability or congenital malformations
  • Cardiopulmonary Testing Contraindications:
  • Medically unfit to complete CPET (cardiopulmonary exercise testing) after evaluation
  • Poor Compliance:
  • History of non-adherence making protocol completion unlikely
  • Life Expectancy:
  • Prognosis ≤1 year

结局指标

主要结局

6MWD

时间窗: 12week

次要结局

未报告次要终点

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Sponsor

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