DysphagiaNCT06190171
Respiratory Strength Training in Heart Transplant Recipients
A study testing Active respiratory muscle strength training in people with Dysphagia and Heart Transplant Recipients, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dysphagia, Heart Transplant Recipients
- What is being tested?
- Active respiratory muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Cara Donohue, 615-852-5085, cara.donohue@vumc.org
Jill Cable, 615-852-5085, irad.lab@vumc.org
About this study
Official title: Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients
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
Read the 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.
- Conditions
- Dysphagia, Heart Transplant Recipients
- Being tested
- Active respiratory muscle strength training, Sham respiratory muscle strength training
- Keywords
- dysphagia, deglutition, deglutition disorders, swallowing, breathing, cough, swallowing disorders, heart transplant recipients, respiratory muscle strength training
- Medical subject headings
- Deglutition Disorders, Respiratory Aspiration, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active respiratory muscle strength trainingDevice
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 trainingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Active respiratory muscle strength training | Experimental | Enrolled heart transplant patients will undergo active preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. Receives: Device: Active respiratory muscle strength training |
| Sham respiratory muscle strength training | Sham comparator | Enrolled heart transplant patients will undergo sham preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. For individuals completing sham respiratory strength training, the spring will be removed from the devices as has been done in prior sham-controlled trials. Receives: Device: Sham respiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum expiratory pressure between pre and post respiratory strength training
A measure of respiratory strength while breathing out
Measured: 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
A measure of respiratory strength while breathing in
Measured: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Secondary outcomes (5)
Change in cough peak expiratory flow between pre and post respiratory strength training
A measure of cough strength
Measured: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
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.
Measured: post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
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.
Measured: pre-surgery (baseline), post-surgery
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).
Measured: pre-surgery (baseline), post-surgery
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.
Measured: baseline, post-intervention/pre-surgery (an average of 2-6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start17 May 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, sham controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Donohue, Ph.D. CCC-SLP, Vanderbilt University Medical Center
- Investigators
- Cara Donohue, Ph.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190171
- Sponsor's protocol ID
- 232071
- Other IDs
- 24CDA1257668
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Respiratory Strength Training on Postoperative Health for Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT06190171
- Acronym / sponsor ID
- 232071
- Conditions
- Dysphagia, Heart Transplant Recipients
- Keywords
- dysphagia, deglutition, deglutition disorders, swallowing, breathing, cough, swallowing disorders, heart transplant recipients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, sham controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Active respiratory muscle strength training | Experimental | Device: Active respiratory muscle strength trainingEnrolled heart transplant patients will undergo active preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. |
| Sham respiratory muscle strength training | Sham comparator | Device: Sham respiratory muscle strength trainingEnrolled heart transplant patients will undergo sham preoperative respiratory strength training using two respiratory strength training devices from enrollment until they receive a heart transplant. For individuals completing sham respiratory strength training, the spring will be removed from the devices as has been done in prior sham-controlled trials. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active respiratory muscle strength trainingDevices 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). | Device | Active respiratory muscle strength training |
| Sham respiratory muscle strength trainingSprings 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). | Device | Sham respiratory muscle strength training |
Primary outcome
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)
A measure of respiratory strength while breathing out
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)
A measure of respiratory strength while breathing in
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cara Donohue, Ph.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active respiratory muscle strength training in people with Dysphagia and Heart Transplant Recipients, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cara Donohue, Ph.D. (615-852-5085, cara.donohue@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.