Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: EXPECT-PH
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention
研究概览
简要总结
This study is being completed to determine the feasibility and acceptability of completing a home-based, structured, low-to-moderate intensity exercise training program in chronic thromboembolic pulmonary hypertension (CTEPH) patients following surgical or percutaneous intervention. Eligible participants will be enrolled and have a 12 week home based exercise training program.
The study team hypothesizes that:
The following percentage of participants successfully complete the ramp-up phase of the exercise program:
- Greater or equal to 70% at end of week 7
- Greater or equal to 80% at end of week 10
- Greater or equal to 90% at end of week 12
- Greater or equal to 80% of participants will both complete ≥1 week of maintenance phase exercise and complete 12 weeks of the exercise intervention.
- Patients will have no adverse events, defined as syncope, worsening World Health Organization (WHO) functional class, pulmonary hypertension (PH) related hospitalization, or death, caused by the exercise intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients post-Pulmonary Thromboendarterectomy (PTE) or Balloon Pulmonary Angioplasty (BPA)
- •Planned follow-up at Michigan Medicine for at least one year
- •Has access to an Android or iPhone with study supported operating software, is willing to install MyDataHelps application, and is willing to wear a smart watch while awake
排除标准
- •Life expectancy under 1 year
- •Orthopedic, neurological, or psychiatric condition limiting ability to actively engage in exercise training session
- •Currently receiving palliative care and/or in hospice care
- •Persistent severe Right Ventricular (RV) dysfunction on echocardiography post BPA or PTE
- •Recently completed, current enrollment, or planned enrollment in pulmonary rehabilitation
- •Moderate or severe obstructive lung disease or restrictive lung disease
- •Arterial oxygen saturation (SpO2) <88% during 6 minute walk test(6MWT) on baseline home oxygen prescription
- •Wrist too large to wear a smart watch comfortably.
- •Participant noted to wear smart watch for less than 8 hours per day prior to intervention.
- •Determined to be unsafe for participation in exercise therapy as assessed by the clinical team.
- •Those with mobility issues that are unable to complete 6MWT.
- •Participant has sex minute walk distance (6MWD) greater or equal to 90% predicted at visit
- •Pregnancy or lactation
- •Non-English speaking
结局指标
主要结局
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention
时间窗: Week 12
Based on intervention weeks 1-12. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention
时间窗: Week 7
Based on intervention weeks 1-7. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention
时间窗: Week 10
Based on intervention weeks 1-10. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
次要结局
- Number of adverse events(12 weeks)
研究者
Brahmajee K Nallamothu
Professor of Internal Medicine
University of Michigan