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Administrative Changes.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home exercise training | Experimental | Individualized exercise prescription will be provided based on the gathered cardiopulmonary exercise test data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home exercise training | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 7 |
| 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. | Week 10 |
| 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vikas Aggarwal, MD | University of Michigan | Principal Investigator |
| Bramajee Nallamothu, MD | University of Michigan | Principal Investigator |
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|
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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