Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Location contact
Cara Donohue
CONTACT
Jill Cable
CONTACT
NCT Number: NCT06190171
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
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Cara Donohue
CONTACT
Jill Cable
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
A measure of respiratory strength while breathing out
Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
A measure of respiratory strength while breathing in
Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
A measure of cough strength
Time frame: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
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: pre-surgery (baseline), post-surgery
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
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: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
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.
Contact information is provided by the study sponsor or research team.
Vanderbilt University Medical Center
Other
Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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