Recruiting

Respiratory Strength Training

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06190171

Conditions

Dysphagia

Heart Transplant Recipients

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active respiratory muscle strength training

Sham respiratory muscle strength training

Study Details

Brief 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

Conditions

Dysphagia

Heart Transplant Recipients

Study ID

NCT06190171

Start date

May 17, 2024

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 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).

Primary outcome measure

  • Change in maximum expiratory pressure between pre and post respiratory strength training [ Time Frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline) ]
  • Change in maximum inspiratory pressure between pre and post respiratory strength training [ Time Frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline) ]

Central Contacts and Locations

Central contacts

Cara Donohue, Ph.D.

615-852-5085cara.donohue@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Cara Donohue

615-852-5085cara.donohue@vumc.org

Jill Cable

615-852-5085irad.lab@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • dysphagia
  • deglutition
  • deglutition disorders
  • swallowing
  • breathing
  • cough
  • swallowing disorders
  • heart transplant recipients
  • respiratory muscle strength training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-07.