Respiratory Strength Training in Heart Transplant Recipients

Impact of Preoperative Respiratory Strength Training on Postoperative Health for 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

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia; Heart Transplant Recipients
• Intervention / Treatment: Behavioral: Active respiratory muscle strength training; Behavioral: Sham respiratory muscle strength training

Detailed Description

This study will involve three in-person research evaluations (two to our lab, one 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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cara Donohue, Ph.D.; Phone Number: 615-852-5085; Email: cara.donohue@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 3-6
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. Individuals undergoing evaluation or active waitlisting for multiorgan transplant or with a waitlist status of 1 or 2
4. No access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions
5. Unwilling or unable to undergo testing procedures and complete the exercise training program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).
Sham Comparator: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cough peak expiratory flow between pre and post respiratory strength training	A measure of cough strength	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Patient-reported treatment burden	Patients will complete the exercise therapy burden questionnaire (ETBQ). Scores on the ETBQ range from 0-100 with higher scores indicating greater burden.	post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Patient reported swallow function	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.	post-intervention/pre-surgery (an average of 2-6 weeks after baseline), post-surgery
Change in penetration-aspiration scale scores between before and after 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).	post-intervention/pre-surgery (an average of 2-6 weeks after baseline), post-surgery
Change in clinical frailty scale score	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.	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: breathing; cough; dysphagia; swallowing; deglutition; deglutition disorders; heart transplant recipients; swallowing disorders; respiratory muscle strength training
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 232071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No