Respiratory Strength Training in Heart Transplant Recipients

Last updated: May 26, 2025
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn

Treatment

Active respiratory muscle strength training

Sham respiratory muscle strength training

Clinical Study ID

NCT06190171
232071
24CDA1257668
  • Ages 18-90
  • All Genders

Study Summary

This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation.

Participants will:

  • undergo tests of breathing, cough, and swallow function

  • complete questionnaires about the treatment, their swallow function

  • complete breathing exercises daily

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (18-90 years old)

  2. Not pregnant

  3. Undergoing evaluation or actively waitlisted for heart transplantation at VUMC witha waitlist status of 1-6

  4. Have a computer, tablet or electronic device with a stable internet connection fortelehealth sessions (outpatient)

  5. Be willing to undergo testing procedures and complete the exercise training program.

Exclusion

Exclusion Criteria:

  1. Individual <18 years old, >90 years old

  2. Pregnant

  3. No access to a computer, tablet or electronic device with a stable internetconnection for telehealth sessions

  4. Unwilling or unable to undergo testing procedures and complete the exercise trainingprogram.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Active respiratory muscle strength training
Phase:
Study Start date:
May 17, 2024
Estimated Completion Date:
March 31, 2027

Study Description

This study will involve three in-person research evaluations to our lab or in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, and completion of questionnaires. Following the initial research evaluation, individuals will complete daily exercises of active or sham respiratory muscle strength training for several weeks with one telehealth or in-person session per week. The exercises will take 10-15 minutes to complete, and individuals will fill out training logs daily. Prior to transplantation and after completion of the breathing exercises, individuals will undergo a second research evaluation. Then, following surgery, individuals will undergo a third research evaluation and outcomes will be tracked via the electronic health records system.

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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