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