Assessment of Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of steps per day
研究概览
简要总结
Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH)
详细描述
Each patient was educated about the benefits of PhA in PAH on the initial visit. Patients wore pedometers (Omron HJ-321-E) for 2 weeks. After PhA assessment, the patients were contacted by a physician. Patients who walked <5,000 steps per day were recommended to increase PhA, and patients who walked ≥5,000 steps per day were recommended to maintain PhA. Patients wore pedometers for 3 months until their next visit. The primary endpoint was the number of steps after 12 weeks of the study; the secondary endpoint was the 6-minute walk test distance (6MWD), quality of life (SF-36), acceptance of the disease, and anxiety and depression level (HADS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age equal to or greater than 18 years
- •PAH diagnosis according to current guidelines, confirmed by right heart catheterization
- •optimal pharmacological treatment
- •stable clinical condition at least 3 months before inclusion in the study
- •Informed consent to participate in your own
排除标准
- •Age under 18 years
- •a type of hypertension other than PAH
- •a neurological or orthopedic disease that prevents walking and performing the 6-minute walk test
- •mental illness that prevents cooperation and assessment of quality of life survey
- •lack of consent to participate in the study
结局指标
主要结局
Number of steps per day
时间窗: At baseline, after initial period 2 weeks
Number of steps per day monitored by pedometer Omron HJ-321-E
次要结局
- Change in 6-minute walk distance(At baseline, 3 months)
- Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD(At baseline, 3 months)
- Compliance with counting steps(at 3 months)
- Change in the hospital anxiety and depression scale (HADS)(At baseline, 3 months)
- Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP)(At baseline, 3 months)
- Change in quality of life (SF-36)(At baseline, 3 months)
- Change in the acceptance of illness (AIS)(At baseline, 3 months)