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

NCT05693779 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-06-07

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Vikas Aggarwal, MD · University of Michigan

  • Bramajee Nallamothu, MD · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-02-29
Completion
2024-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693779 on ClinicalTrials.gov