An interventional study of Active respiratory muscle strength training and Sham respiratory muscle strength training in Dysphagia and Heart Transplant Recipients, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Prevention
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:
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
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Exclusion Criteria:
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.
Device: Active 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.
Device: Sham 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).
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).
Change in maximum expiratory pressure between pre and post respiratory strength training
A measure of respiratory strength while breathing out
Time frame: 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
Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Change in cough peak expiratory flow between pre and post respiratory strength training
A measure of cough strength
Time frame: 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.
Time frame: 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.
Time frame: pre-surgery (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).
Time frame: pre-surgery (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.
Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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