Implementing the Wuqinxi on Patients With Pulmonary Arterial Hypertension to Enhance Exercise Tolerance ，Reduce Negative Emotions and Quality of Life: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Biomarker
研究概览
简要总结
Aims and objective: The primary objective of this study was to assess the effects of a traditional Chinese Qigong practice known as Wuqinxi on activity tolerance，negative emotions and quality of life in pulmonary arterial hypertension patients.
Methods: In the current prospective, randomized-controlled clinical trial, 60 patients with pulmonary arterial hypertension were randomly assigned to one of two groups: intervention or control. Participants in the intervention group received targeted pharmacological therapy and five sessions of qigong exercise per week. In contrast, individuals in the control group underwent targeted drug therapy and routine care. Observe the change in exercise tolerance as measured by the 6-minute walking distance (6MWD). Serological indicators (n-terminal brain natriuretic peptide precursor, NT-pro BNP) ,negative emotions(PHQ-9/GAD-7)and the MOS Item Short Form Health Survey (SF-36) or emPHasis-10 were used to assess patients condition and quality of life.
详细描述
In the previous study, we examined the effects of comprehensive respiratory function exercise on exercise tolerance in patients with PAH. The results indicated that limb exercise combined with breath regulating guidance affects patients' physical health.Given these TCM principles, the current study investigated the clinical utility of Wuqinxi for improving patients' exercise tolerance and quality of life by comparing the intervention and control groups' NT-pro BNP scores, 6MWD data, negative emotionsand quality of life indices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •(1) patients with PAH related to IPAH(idiopathic pulmonary arterial), CTD(connective tissue disease), DPAH(drug-induced pulmonary hypertension), CHD(congenital heart disease) and associated with secondary disease, aged 18-75 years; (2)patients with PAH as defined by the American College of Cardiology Foundation/American Heart Association (right heart catheterization: mPAP≥20mmHg and PAWP≤15mmHg); (3) patients with WHO pulmonary arterial hypertension functional class II-III; (4) patients on drug-based treatment for ≥1 month and in the recovery period; (5) could read, write, and comprehend Chinese; (6) volunteered for this trial and provided written informed consent.
排除标准
- •(1) patients unable or unwilling to complete the 6MWD; (2) The physician confirms that the disease requires bed rest or with severely impaired cardiopulmonary function, tumors, and limb dysfunction; (3) patients who were unable to complete the questionnaire independently; (4) a history of mental problems and cognitive impairment; or have had psychotherapy or taken any psychiatric medication in the past or present.(5) patients who were hospitalized with severe disease.
结局指标
主要结局
Biomarker
时间窗: admission and discharge at the end of 3 months
NT-pro BNP was detected using a colloidal gold immunochromatography analyzer, model LEPU Quant 800, made in Beijing, China.
6-minute walking distance
时间窗: admission and discharge at the end of 3 months
The 6MWD test for selected patients with stable illness was conducted in the corridor of the cardiology ward
Quality of Life Assessment
时间窗: admission and discharge at the end of 3 months
emPHasis-10 or pulmonary hypertension health quality of life score, SF-36
次要结局
- Negative emotions(admission and discharge at the end of 3 months)