Respiratory Strength Training in Heart Transplant Recipients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorVanderbilt University Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Individual <18 years old, >90 years old
Pregnant
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active respiratory muscle strength training
DeviceDevices 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 respiratory muscle strength training
DeviceSprings 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).
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Active respiratory muscle strength trainingExperimental treatment 1 intervention
Group B: Sham respiratory muscle strength trainingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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-surgery4
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-surgerySponsors and contacts
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Source ClinicalTrials.gov