Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant

Mayo Clinic

Status: Enrolling

Conditions: Post-Lung Transplantation Bronchiectasis

Treatments: Other: Cardiopulmonary rehabilitation post lung transplant; Device: POWERBreathe Plus®

Study type: Interventional

Funder types: Other

Identifiers

NCT04783155

20-012778

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

12-weeks pulmonary rehabilitation training plus inspiratory muscle training

Experimental group

Description:

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.

Treatment:

Device: POWERBreathe Plus®

Other: Cardiopulmonary rehabilitation post lung transplant

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

Placebo Comparator group

Description:

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.

Treatment:

Device: POWERBreathe Plus®

Other: Cardiopulmonary rehabilitation post lung transplant