Respiratory Strength Training in Heart Transplant Recipients

Dysphagia Clinical Trial

Official title:

Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190171
• Other study ID #: 232071
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: Cara Donohue, Ph.D.
• Phone: 615-852-5085
• Email: cara.donohue[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This study will involve three in-person research evaluations (two to our lab, one 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Heart Transplant Recipients

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximum expiratory pressure between pre and post respiratory strength training	A measure of respiratory strength while breathing out	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Primary	Change in maximum inspiratory pressure between pre and post respiratory strength training	A measure of respiratory strength while breathing in	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Secondary	Change in cough peak expiratory flow between pre and post respiratory strength training	A measure of cough strength	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Secondary	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.	post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Secondary	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.	post-intervention/pre-surgery (an average of 2-6 weeks after baseline), post-surgery
Secondary	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).	post-intervention/pre-surgery (an average of 2-6 weeks after baseline), post-surgery
Secondary	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.	baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)