NCT05968859进行中（未招募）不适用
Peripheral Limitations in Pulmonary Hypertension and Effects of Muscle Training - The PH Training Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise
研究概览
简要总结
The investigators are doing this research study to compare whole body aerobic training with isolated leg training (with weights) and its impact on effectiveness in symptoms and quality of life in patients with Pulmonary Arterial Hypertension (PAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •Pulmonary Arterial Hypertension (PAH) Subjects:
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •NYHA Class II-IV
- •LVEF ≥ 40 % within the preceding year.
- •No hospitalizations due to heart failure in the preceding 30 days.
- •No recent initiation of pulmonary vasodilator in the last 60 days
- •Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP <25 mm Hg).
- •Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms
- •Healthy Controls:
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •No known diagnosis of heart failure
排除标准
- •Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
- •Planned coronary, carotid, or peripheral artery revascularization.
- •Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
- •Wheelchair bound or orthopedic inability to exercise
- •Chronic hypoxemia with inability to exercise without oxygen supplementation (PAH Subjects) or need for oxygen supplementation (Healthy Controls)
- •Skeletal muscle myopathy
- •History of rhabdomyolysis
- •Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening.
- •Receipt of any investigational medicinal product within 30 days before screening
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- •Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
- •Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.
研究组 & 干预措施
Healthy Controls
No Intervention
Healthy controls will be enrolled to complete the baseline study assessments for generation of normal reference values for comparison. Healthy controls will not undergo randomized exercise training interventions or repeat assessments.
Aerobic Training
Active Comparator
Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo aerobic training for 12 weeks, and then repeat study assessments.
干预措施: Aerobic Training (Behavioral)
Leg Training
Experimental
Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo leg training for 12 weeks, and then repeat study assessments.
干预措施: Leg Training (Behavioral)
结局指标
主要结局
Change in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise
时间窗: Baseline, approximately 12 weeks
Dm is measured in ml/mm Hg/min during supine cycle exercise
次要结局
- Change in maximal mitochondrial respiration(Baseline, approximately 12 weeks)
- Change in peak O2 consumption (peak VO2) during supine cycle exercise(Baseline, approximately 12 weeks)
- Change in Quality of Life as measured by the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) questionnaire(Baseline, approximately 8 weeks, approximately 12 weeks)
- Change in Quality of Life as measured by the emPHasis-10 questionnaire(Baseline, approximately 8 weeks, approximately 12 weeks)
- Change in skeletal muscle O2 diffusive conductance (Dm) during single knee-extensor exercise(Baseline, approximately 12 weeks)
- Change in Quality of Life as measured by the 36-Item Short-Form Survey (SF-36)(Baseline, approximately 8 weeks, approximately 12 weeks)
研究者
研究点 (2)
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