Respiratory Strength Training in Heart Transplant Recipients

Not Applicable

Recruiting

• Conditions: Dysphagia; Heart Transplant Recipients
• Interventions: Behavioral: Sham respiratory muscle strength training; Behavioral: Active respiratory muscle strength training

• Registration Number: NCT06190171
• Lead Sponsor: Vanderbilt University Medical Center

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-05
• Study Start: 2024-05-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-04-01
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham respiratory muscle strength training	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.
Active respiratory muscle strength training	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.

Primary Outcome Measures

Name	Time	Method
Change in maximum expiratory pressure between pre and post respiratory strength training	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)	A measure of respiratory strength while breathing out
Change in maximum inspiratory pressure between pre and post respiratory strength training	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)	A measure of respiratory strength while breathing in

Secondary Outcome Measures

Name	Time	Method
Change in cough peak expiratory flow between pre and post respiratory strength training	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)	A measure of cough strength
Patient-reported treatment burden	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.
Patient reported swallow function	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.
Change in clinical frailty scale score	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.
Change in penetration-aspiration scale scores between before and after surgery	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).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States