Peripheral Limitations in Pulmonary Hypertension and Effects of Muscle Training - The PH Training Trial

Mayo Clinic2 个研究点分布在 1 个国家目标入组 45 人2024年1月2日

适应症Pulmonary Arterial Hypertension Healthy

干预措施Aerobic Training Leg Training

概览

阶段: 不适用
干预措施: Aerobic Training
疾病 / 适应症: Pulmonary Arterial Hypertension
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
状态: 进行中（未招募）
最后更新: 12天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2024年1月2日

结束日期

2026年9月1日

最后更新

12天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Mayo Clinic

责任方

Principal Investigator

主要研究者

Yogesh Reddy

Principal Investigator

Mayo Clinic

入排标准

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.

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.

研究组 & 干预措施

Aerobic Training

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

Leg Training

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

Healthy Controls

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.

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)