Respiratory Strength Training in Heart Transplant Recipients

NCT06190171 | Recruiting

• 2 other identifiers: 23207124CDA1257668
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in maximum expiratory pressure between pre and post respiratory strength training

  A measure of respiratory strength while breathing out

  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

  A measure of respiratory strength while breathing in

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

Secondary Outcomes (5)

• 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)

• Patient-reported treatment burden

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

• Patient reported swallow function

  pre-surgery (baseline), post-surgery

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

  pre-surgery (baseline), post-surgery

• Change in clinical frailty scale score

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

Study Arms (2)

Active respiratory muscle strength training

EXPERIMENTAL

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.

Behavioral: Active respiratory muscle strength training

Sham respiratory muscle strength training

SHAM COMPARATOR

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.

Behavioral: Sham respiratory muscle strength training

Interventions

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).

Active respiratory muscle strength training

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).

Sham respiratory muscle strength training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders; Respiratory Aspiration; Cough

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Cara Donohue, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara Donohue, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be assigned to active or sham respiratory strength training using block randomization and will be blinded to their assigned treatment. Researchers performing evaluations and data analysis will also be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Medical Speech-Language Pathology

Model Details: randomized, sham controlled clinical trial

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 5, 2024
• Study Start: May 17, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)