Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05693779

Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 25
Sponsor: University of Michigan

Location: United States

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 7Greater or equal to 80% at end of week 10Greater or equal to 90% at end of week 12Greater 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.

Eligibility Criteria

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 yearHas 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 awakeExclusion Criteria:Life expectancy under 1 yearOrthopedic, neurological, or psychiatric condition limiting ability to actively engage in exercise training sessionCurrently receiving palliative care and/or in hospice carePersistent severe Right Ventricular (RV) dysfunction on echocardiography post BPA or PTERecently completed, current enrollment, or planned enrollment in pulmonary rehabilitationModerate or severe obstructive lung disease or restrictive lung diseaseArterial oxygen saturation (SpO2) <88% during 6 minute walk test(6MWT) on baseline home oxygen prescriptionWrist 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 lactationNon-English speaking

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05693779). StuddyBuddy aggregates publicly available trial information.