Respiratory Strength Training in Heart Transplant Recipients

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Dysphagia; Heart Transplant Recipients

Treatments: Behavioral: Sham respiratory muscle strength training; Behavioral: Active respiratory muscle strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT06190171

232071

24CDA1257668 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Active respiratory muscle strength training

Experimental group

Description:

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.

Treatment:

Behavioral: Active respiratory muscle strength training

Sham respiratory muscle strength training

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham respiratory muscle strength training