Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chron… (NCT05693779) | Clinical Trial Compass
WithdrawnNot Applicable
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
Stopped: Administrative Changes.
0Started 2023-05
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 1.
* Pregnancy or lactation
* Non-English speaking
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention
Timeframe: Week 7
2
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention
Timeframe: Week 10
3
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention