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Clinical Trials/NCT06190171
NCT06190171
Recruiting
Not Applicable

Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients

Vanderbilt University Medical Center1 site in 1 country90 target enrollmentMay 17, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphagia
Sponsor
Vanderbilt University Medical Center
Enrollment
90
Locations
1
Primary Endpoint
Change in maximum expiratory pressure between pre and post respiratory strength training
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 17, 2024
End Date
March 31, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cara Donohue, Ph.D. CCC-SLP

Assistant Professor, Director of Medical Speech-Language Pathology

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Individual \<18 years old, \>90 years old
  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 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

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

A measure of respiratory strength while breathing in

Secondary Outcomes

  • 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 clinical frailty scale score(baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline))
  • Change in penetration-aspiration scale scores between before and after surgery(pre-surgery (baseline), post-surgery)

Study Sites (1)

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