Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06190171

Respiratory Strength Training in Heart Transplant Recipients

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Individual <18 years old, >90 years old
  • Pregnant
  • No access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions
  • Unwilling or unable to undergo testing procedures and complete the exercise training program.

Treatment and study plan

Active respiratory muscle strength training

Behavioral

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

Behavioral

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 outcomes

  1. 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)

    A measure of respiratory strength while breathing out

  2. 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)

    A measure of respiratory strength while breathing in

Secondary outcomes

  1. Change in cough peak expiratory flow between pre and post respiratory strength training

    Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)

    A measure of cough strength

  2. Patient-reported treatment burden

    Time frame: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)

    Patients will complete the exercise therapy burden questionnaire (ETBQ). Scores on the ETBQ range from 0-100 with higher scores indicating greater burden.

  3. Patient reported swallow function

    Time frame: pre-surgery (baseline), post-surgery

    Patients will complete the swallowing and eating related fatigue (SERF) questionnaire. Scores on the SERF range from 0-48 with higher scores indicating greater impairment.

  4. Change in penetration-aspiration scale scores between before and after surgery

    Time frame: pre-surgery (baseline), post-surgery

    The penetration aspiration scale is a validated 8-point ordinal rating scale that measures the depth of airway invasion and the patient's response during swallowing. Scores range from 1 to 8 with a score of 1 indicating a safe swallow (best score) and 8 indicating silent aspiration (worst score).

  5. Change in clinical frailty scale score

    Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)

    The Clinical Frailty Scale (CFS) is a measure of physical function. Scores on the CFS range from 1-9 with higher scores indicating greater impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Cara Donohue, Ph.D.

CONTACT

[email protected]

615-852-5085

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.