Clinical trial NCT05693779: Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
Official title: Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: EXPECT-PH
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Exercise
Balloon pulmonary angioplasty
Pulmonary thromboendarterectomy
Smart watch
Treadmill exercise test
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 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

Primary outcomes:
measure: Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention
timeFrame: Week 7
measure: Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention
timeFrame: Week 10
measure: Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention
timeFrame: Week 12
Secondary outcomes:
measure: Number of adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Vikas Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Bramajee Nallamothu, MD
role: PRINCIPAL_INVESTIGATOR
References: