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Behavioral Intervention

Respiratory Strength Training for Heart Transplant Recipients

N/A
Recruiting
Led By Cara Donohue, Ph.D.
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (18-90 years old)
Be older than 18 years old
Must not have
Individual <18 years old, >90 years old
Individuals undergoing evaluation or active waitlisting for multiorgan transplant or with a waitlist status of 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention/pre-surgery (an average of 2-6 weeks after baseline), post-surgery
Awards & highlights

Summary

This trial is looking at whether doing breathing exercises before heart transplant surgery can help patients recover better. Previous studies have shown that breathing exercises can improve breathing, coughing, and swallowing in patients with other conditions

Who is the study for?
This trial is for adults aged 18-90 who are being evaluated or on the waitlist for a heart transplant at VUMC with a status of 3-6. Participants must be willing to do tests and breathing exercises, not be pregnant, and have internet access for telehealth sessions.
What is being tested?
The study compares two types of respiratory muscle strength training: an active one that might improve breathing and swallowing functions after heart surgery, versus a sham (placebo) exercise program. It aims to see if pre-surgery exercises can help recovery.
What are the potential side effects?
Since this trial involves non-invasive breathing exercises, side effects may be minimal but could include discomfort or fatigue from the exercises. The impact on individuals will vary based on their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am between 18 and 90 years old.
Select...
I am being evaluated for or am on the waitlist for a multiorgan transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in maximum expiratory pressure between pre and post respiratory strength training
Change in maximum inspiratory pressure between pre and post respiratory strength training
Secondary outcome measures
Change in clinical frailty scale score
Change in cough peak expiratory flow between pre and post respiratory strength training
Change in penetration-aspiration scale scores between before and after surgery
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active respiratory muscle strength trainingExperimental Treatment1 Intervention
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 II: Sham respiratory muscle strength trainingPlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,844 Total Patients Enrolled
Cara Donohue, Ph.D.Principal InvestigatorVanderbilt University Medical Center
~60 spots leftby Apr 2026
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