Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Behavioral: Home exercise training
- Registration Number
- NCT05693779
- Lead Sponsor
- University of Michigan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Home exercise training Home exercise training Individualized exercise prescription will be provided based on the gathered cardiopulmonary exercise test data.
- Primary Outcome Measures
Name Time Method Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention 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 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 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.
- Secondary Outcome Measures
Name Time Method Number of adverse events 12 weeks These will be defined as hospitalization due to CTEPH-specific decompensation, worsening World Health Organization (WHO) functional class, syncope, and death.