Post-Lung Transplantation BronchiectasisNCT04783155
Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant
A study testing POWERBreathe Plus® and Cardiopulmonary rehabilitation post lung transplant in people with Post-Lung Transplantation Bronchiectasis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Lung Transplantation Bronchiectasis
- What is being tested?
- POWERBreathe Plus® and Cardiopulmonary rehabilitation post lung transplant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.
Who cannot join
- Patients who do not survive the intra-operative period during the transplant surgery.
- Patients undergoing retransplantation.
- Patients undergoing multiorgan transplantation.
- Patients who are not willing to or who are unable to give written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bryan Taylor contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Temetria Miller, 904-953-2000, miller.temetria@mayo.edu
About this study
Official title: Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial
The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.
- Conditions
- Post-Lung Transplantation Bronchiectasis
- Being tested
- POWERBreathe Plus®, Cardiopulmonary rehabilitation post lung transplant
- Keywords
- Inspiratory muscle training, post lung transplant, exercise capacity, breathing
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWERBreathe Plus®Device
Commercially available pressure-threshold device
Cardiopulmonary rehabilitation post lung transplantOther
Pulmonary function, lung diffusing capacity for carbon monoxide, inspiratory muscle strength, and diaphragm dimensions will be assessed in each patient. Each patient will also undergo a cardiopulmonary exercise test (CPET), 6 minute walk test, and an inspiratory muscle endurance test
| Study group | Role | What they receive |
|---|---|---|
| 12-weeks pulmonary rehabilitation training plus inspiratory muscle training | Experimental | To assess maximum inspiratory pressure, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. Receives: Device: POWERBreathe Plus®; Other: Cardiopulmonary rehabilitation post lung transplant |
| 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle | Placebo comparator | To assess maximum inspiratory pressure with placebo, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. The resistance will be set to about 5% throughout the study. Receives: Device: POWERBreathe Plus®; Other: Cardiopulmonary rehabilitation post lung transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
The maximal strength generating capacity of the inspiratory muscles.
Measured: 12 weeks
Secondary outcomes (1)
Maximal oxygen uptake (V̇O2max) measured in mL/kg/min
Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start10 May 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Lung Transplantation BronchiectasisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan Taylor, Mayo Clinic
- Investigators
- Bryan Taylor, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783155
- Sponsor's protocol ID
- 20-012778
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2021
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04783155
- Acronym / sponsor ID
- 20-012778
- Conditions
- Post-Lung Transplantation Bronchiectasis
- Keywords
- Inspiratory muscle training, post lung transplant, exercise capacity, breathing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Mar 2021 (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.
The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-weeks pulmonary rehabilitation training plus inspiratory muscle training | Experimental | Device: POWERBreathe Plus®, Other: Cardiopulmonary rehabilitation post lung transplantTo assess maximum inspiratory pressure, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. |
| 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle | Placebo comparator | Device: POWERBreathe Plus®, Other: Cardiopulmonary rehabilitation post lung transplantTo assess maximum inspiratory pressure with placebo, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. The resistance will be set to about 5% throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.
Key exclusion criteria (4 listed)
- Patients who do not survive the intra-operative period during the transplant surgery.
- Patients undergoing retransplantation.
- Patients undergoing multiorgan transplantation.
- Patients who are not willing to or who are unable to give written informed consent.
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 |
|---|---|---|
| POWERBreathe Plus®Commercially available pressure-threshold device | Device | 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle, 12-weeks pulmonary rehabilitation training plus inspiratory muscle training |
| Cardiopulmonary rehabilitation post lung transplantPulmonary function, lung diffusing capacity for carbon monoxide, inspiratory muscle strength, and diaphragm dimensions will be assessed in each patient. Each patient will also undergo a cardiopulmonary exercise test (CPET), 6 minute walk test, and an inspiratory muscle endurance test | Other | 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle, 12-weeks pulmonary rehabilitation training plus inspiratory muscle training |
Primary outcome
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
Time frame: 12 weeks
The maximal strength generating capacity of the inspiratory muscles.
1 secondary outcome
Maximal oxygen uptake (V̇O2max) measured in mL/kg/min
Time frame: 12 weeks
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 6 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Bryan Taylor contact
Bryan Taylor, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POWERBreathe Plus® and Cardiopulmonary rehabilitation post lung transplant in people with Post-Lung Transplantation Bronchiectasis, run by Mayo Clinic 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 1 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 6 Jan 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 Bryan Taylor (taylor.bryan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory mouth pressure (MIP) measured in cmH2O (time frame: 12 weeks). 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 6 Jan 2026.