Respiratory Strength Training in Heart Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active respiratory muscle strength training, Sham respiratory muscle strength training.
- Who it may be relevant to
- Registry conditions: Dysphagia, Heart Transplant Recipients. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients
Overview
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.
Interventions
- Behavioral Active 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). - Behavioral Sham respiratory muscle strength training
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).
Primary outcome measures
- 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)]
- 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)]
Secondary outcome measures (5)
- Change in cough peak expiratory flow between pre and post respiratory strength training [Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]
- Patient-reported treatment burden [Time frame: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]
- Patient reported swallow function [Time frame: pre-surgery (baseline), post-surgery]
- Change in penetration-aspiration scale scores between before and after surgery [Time frame: pre-surgery (baseline), post-surgery]
- Change in clinical frailty scale score [Time frame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT06190171 · 232071 · 24CDA1257668