Respiratory Strength Training in Heart Transplant Recipients

NCT ID: NCT06190171

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2027-03-31

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.

Conditions

Dysphagia; Heart Transplant Recipients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active respiratory muscle strength training

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Sham respiratory muscle strength training

Intervention Type: 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).

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cara Donohue, Ph.D. CCC-SLP

Assistant Professor, Director of Medical Speech-Language Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cara Donohue, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cara Donohue, Ph.D.

Role: CONTACT

cara.donohue@vumc.org

615-852-5085

Facility Contacts

Cara Donohue

Role: primary

cara.donohue@vumc.org

615-852-5085

Jill Cable

Role: backup

irad.lab@vumc.org

615-852-5085

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

24CDA1257668

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

232071

Identifier Type: -

Identifier Source: org_study_id