Back to resultsExercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension (EXPECT-PH)
Primary Purpose
Chronic Thromboembolic Pulmonary Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring Exercise, Balloon pulmonary angioplasty, Pulmonary thromboendarterectomy, Smart watch, Treadmill exercise test
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home exercise training
Arm Description
Individualized exercise prescription will be provided based on the gathered cardiopulmonary exercise test data.
Outcomes
Primary Outcome Measures
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention
Based on intervention weeks 1-7. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention
Based on intervention weeks 1-10. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention
Based on intervention weeks 1-12. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Secondary Outcome Measures
Number of adverse events
These will be defined as hospitalization due to CTEPH-specific decompensation, worsening World Health Organization (WHO) functional class, syncope, and death.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05693779
Brief Title
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
Acronym
EXPECT-PH
Official Title
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: EXPECT-PH
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative Changes.
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension
Keywords
Exercise, Balloon pulmonary angioplasty, Pulmonary thromboendarterectomy, Smart watch, Treadmill exercise test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home exercise training
Arm Type
Experimental
Arm Description
Individualized exercise prescription will be provided based on the gathered cardiopulmonary exercise test data.
Intervention Type
Behavioral
Intervention Name(s)
Home exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 7 of the intervention
Description
Based on intervention weeks 1-7. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Time Frame
Week 7
Title
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 10 of the intervention
Description
Based on intervention weeks 1-10. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Time Frame
Week 10
Title
Percentage of participants who complete the ramp-up phase of the exercise program at end of week 12 of the intervention
Description
Based on intervention weeks 1-12. Compliance data will be documented by participants in virtual exercise logs and reviewed weekly with the study team.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
These will be defined as hospitalization due to CTEPH-specific decompensation, worsening World Health Organization (WHO) functional class, syncope, and death.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikas Aggarwal, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bramajee Nallamothu, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension
We'll reach out to this number within 24 hrs