Clinical trial NCT06190171: Respiratory Strength Training in Heart Transplant Recipients
Official title: Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Heart Transplant Recipients
Keywords: dysphagia
deglutition
deglutition disorders
swallowing
breathing
cough
swallowing disorders
heart transplant recipients
respiratory muscle strength training
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, sham controlled clinical trial
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult (18-90 years old)
2. Not pregnant
3. Undergoing evaluation or actively waitlisted for heart transplantation at VUMC with a waitlist status of 1-6
4. Have a computer, tablet or electronic device with a stable internet connection for telehealth sessions (outpatient)
5. Be willing to undergo testing procedures and complete the exercise training program.

Exclusion Criteria:

1. Individual \<18 years old, \>90 years old
2. Pregnant
3. No access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions
4. Unwilling or unable to undergo testing procedures and complete the exercise training program.

Primary outcomes:
measure: Change in maximum expiratory pressure between pre and post respiratory strength training
timeFrame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
measure: Change in maximum inspiratory pressure between pre and post respiratory strength training
timeFrame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Secondary outcomes:
measure: Change in cough peak expiratory flow between pre and post respiratory strength training
timeFrame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
measure: Patient-reported treatment burden
timeFrame: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
measure: Patient reported swallow function
timeFrame: pre-surgery (baseline), post-surgery
measure: Change in penetration-aspiration scale scores between before and after surgery
timeFrame: pre-surgery (baseline), post-surgery
measure: Change in clinical frailty scale score
timeFrame: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Cara Donohue, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: