Recruiting

Inspiratory Muscle Training

Sponsor:

Mayo Clinic

Code:

NCT04783155

Conditions

Post-Lung Transplantation Bronchiectasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

POWERBreathe Plus®

Cardiopulmonary rehabilitation post lung transplant

Study Details

Brief 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.

Conditions

Post-Lung Transplantation Bronchiectasis

Study ID

NCT04783155

Start date

May 10, 2021

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

\- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 12-weeks pulmonary rehabilitation training plus inspiratory muscle training

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.

placebo comparator: 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle

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.

Interventions

POWERBreathe Plus®

Commercially available pressure-threshold device

Cardiopulmonary rehabilitation post lung transplant

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

Primary outcome measure

  • Maximal inspiratory mouth pressure (MIP) measured in cmH2O [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Bryan Taylor

taylor.bryan@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Temetria Miller

904-953-2000miller.temetria@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Keywords

  • Inspiratory muscle training
  • post lung transplant
  • exercise capacity
  • breathing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-06.