Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension (EXPECT-PH)

University of Michigan

Status

Withdrawn

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Treatments

Behavioral: Home exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT05693779

HUM00214495

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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