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

NCT ID: NCT05693779

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-02-29

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home exercise training

Individualized exercise prescription will be provided based on the gathered cardiopulmonary exercise test data.

Group Type: EXPERIMENTAL

Home exercise training

Intervention Type: BEHAVIORAL

Participants will complete an Exercise Treadmill Test at baseline. The 12 weeks exercise program that will be assigned to each patient will be based on these results. The exercise will be three 20-minute exercise sessions per week for 6 weeks. This will increase to four 60-minute exercise sessions per week at increased intensity progressively over the course of the exercise program. The exercise program will involve walking/jogging, elliptical training, or biking 3-4 times per week for up to an hour each session. If participants don't have access to a bike or elliptical, they will be asked to exercise by walking/jogging.

Participants will also a phone call or video chat that takes about 15 minutes per week to discuss the exercise program and take 2 short surveys weekly on the MyDataHelps application and filling out a logbook recording exercise sessions. In addition, participants activity will be measured by using a smartwatch during the study.

Interventions

Home exercise training

Participants will complete an Exercise Treadmill Test at baseline. The 12 weeks exercise program that will be assigned to each patient will be based on these results. The exercise will be three 20-minute exercise sessions per week for 6 weeks. This will increase to four 60-minute exercise sessions per week at increased intensity progressively over the course of the exercise program. The exercise program will involve walking/jogging, elliptical training, or biking 3-4 times per week for up to an hour each session. If participants don't have access to a bike or elliptical, they will be asked to exercise by walking/jogging.

Participants will also a phone call or video chat that takes about 15 minutes per week to discuss the exercise program and take 2 short surveys weekly on the MyDataHelps application and filling out a logbook recording exercise sessions. In addition, participants activity will be measured by using a smartwatch during the study.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Brahmajee K Nallamothu

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vikas Aggarwal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Bramajee Nallamothu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Other Identifiers

HUM00214495

Identifier Type: -

Identifier Source: org_study_id