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 range18 Years – 75 Years

SexALL

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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

What they're measuring

Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention

Timeframe: Week 7

Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention

Timeframe: Week 10

Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention

Timeframe: Week 12

Trial details

NCT IDNCT05693779

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02

View on ClinicalTrials.gov More Chronic Thromboembolic Pulmonary Hypertension trials