Respiratory Strength Training in Heart Transplant Recipients

Purpose

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

Conditions

  • Dysphagia
  • Heart Transplant Recipients

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Adult (18-90 years old) 2. Not pregnant 3. Undergoing evaluation or actively waitlisted for heart transplantation at VUMC with a waitlist status of 1-6 4. Have a computer, tablet or electronic device with a stable internet connection for telehealth sessions (outpatient) 5. Be willing to undergo testing procedures and complete the exercise training program.

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 internet connection for telehealth sessions 4. Unwilling or unable to undergo testing procedures and complete the exercise training program.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
randomized, sham controlled clinical trial
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Participants will be assigned to active or sham respiratory strength training using block randomization and will be blinded to their assigned treatment. Researchers performing evaluations and data analysis will also be blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active respiratory muscle strength training
Enrolled heart transplant patients will undergo active preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant.
  • Behavioral: Active respiratory muscle strength training
    Devices will be set to 60% of participants' maximum expiratory pressure and maximum inspiratory pressure. Participants will complete training 7 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory muscle strength training (a total of 50 repetitions).
Sham Comparator
Sham respiratory muscle strength training
Enrolled heart transplant patients will undergo sham preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. For individuals completing sham respiratory strength training, the spring will be removed from the devices as has been done in prior sham-controlled trials.
  • Behavioral: Sham respiratory muscle strength training
    Springs will be removed from devices to ensure training is done without resistance. Participants will complete training 7 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory sham muscle strength training (a total of 50 repetitions).

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Cara Donohue
615-852-5085
cara.donohue@vumc.org

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Cara Donohue, Ph.D.
615-852-5085
cara.donohue@vumc.org

Detailed Description

This study will involve three in-person research evaluations (two to our lab, one 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.