Pilot Randomized Trial of Ambulatory Exercise in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Efficacy of a home-based exercise training as measured by change in six-minute walk distance
研究概览
简要总结
The researchers are investigating if changing an individual's behaviors may have an impact on outcomes for patients with pulmonary arterial hypertension (PAH). This research will test the efficacy of a home-based exercise program to improve exercise tolerance and physical activity.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
An independent statistician will develop the randomization schedule and an unblinded study team member will document and maintain the treatment assignment log. The investigators will be adjusting the exercise regimens of those randomized to the exercise program and are unable to be blinded. All patients will receive weekly telephone calls to review activity logs. Outcomes included in the primary and secondary analysis will be blinded as possible. The staff performing the 6-minute walk test (6MWT) and interpreting echocardiograms will be blinded to the group assignment.
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
- •Diagnosis of group 1 Pulmonary Atrial Hypertension (PAH) diagnosed during right heart catheterization (RHC) according to WHO criteria 28
- •WHO functional class II to III
- •Stable clinical condition, with no change in medical therapy for pulmonary arterial hypertension (PAH) for at least 3 months before enrollment
- •Planned follow-up at University of Michigan Hospital Centers over at least 1 year
- •If enrolled in clinical trial, must be in open-label extension stage on stable medications for at least 3 months.
- •Competent to give informed consent
- •Have computer and internet access
排除标准
- •Life expectancy under 1 year
- •Co-morbidities which limit physical activity to a severe degree (i.e., permanently wheelchair bound, musculoskeletal disorders, recent myocardial infarction, unstable arrhythmia)
- •Current substance abuse, and/or a severe psychiatric disorder (including severe depression, psychosis, or dementia) which limits the patient's ability to follow the study protocol
- •Recently completed (<6 months), current enrollment or planned enrollment in pulmonary rehab.
- •≥30 minutes of exercise, ≥ 1 day per week for the previous 3 months
- •Six-minute walk distance <150 meters or >550 meters
- •Moderate or severe obstructive lung disease forced expiratory volume/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration).
- •Moderate or severe restrictive lung disease (total lung capacity < 60% predicted value).
- •Arterial oxygen saturation (SpO2) <88% during 6-minute walk test on baseline home oxygen prescription if applicable or SpO2 <80% if uncorrected shunt.
- •History of exercise-induced syncope or arrhythmias.
- •Pregnancy or lactation
- •Non-English speaking
结局指标
主要结局
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
时间窗: Baseline, 12 weeks
Distance measured in meters
次要结局
- Efficacy of a home-based exercise training as measured by change in treadmill exercise time(Baseline, 12 weeks)
- Efficacy of a home-based exercise training as measured by change in survey score Patient Health Questionnaire (PHQ)-8(Baseline, 6 months)
- Efficacy of a home-based exercise training as measured by change in survey score International Physical Activity Questionnaire Short Form (IPAQ-SF)(Baseline, 6 months)
- Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class(Baseline, 6 months)
- Efficacy of a home-based exercise training as measured by change in six-minute walk distance(Baseline, 6 months)
- Efficacy of a home-based exercise training as measured by change in survey score from the EuroQol five dimension, five level (EQ-5D-5L) questionnaire.(Baseline, 6 months)
- Efficacy of a home-based exercise training as measured by change in survey score The Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT)(Baseline, 6 months)
- Change in physical activity as measured by daily activity captured using the pedometer step count(Baseline, 6 months)
研究者
Thomas Matthew Cascino
Clinical Lecturer in Internal Medicine
University of Michigan