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Inspiratory Muscle Training for Lung Transplant

N/A

Recruiting

Led By Bryan Taylor, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Patients who are not willing to or who are unable to give written informed consent.

Patients who do not survive the intra-operative period during the transplant surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial is testing whether training the muscles used for breathing can help improve quality of life and exercise ability in people who have had a lung transplant.

Who is the study for?

This trial is for patients at Mayo Clinic Florida who have had a single or double lung transplant. It's not for those who didn't survive the surgery, are getting retransplanted, having multiple organs transplanted, or can't consent.

What is being tested?

The study tests if POWERBreathe Plus®, a device to strengthen breathing muscles, along with post-transplant cardiopulmonary rehab improves exercise ability, quality of life and clinical outcomes after lung transplant.

What are the potential side effects?

While specific side effects aren't listed here, inspiratory muscle training may cause temporary muscle soreness or fatigue. Cardiopulmonary rehabilitation generally has minimal risks but could include physical strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a lung transplant at Mayo Clinic Florida.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to give written consent.

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I survived the surgery required for my transplant.

Select...

I am scheduled for or have had a second organ transplant.

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I am undergoing a transplant involving multiple organs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximal inspiratory mouth pressure (MIP) measured in cmH2O

Secondary study objectives

Maximal oxygen uptake (V̇O2max) measured in mL/kg/min

Other study objectives

Peak work rate (Wpeak) (watts)

Six-minute walk test distance (6MWTd) measured in meters (m)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 12-weeks pulmonary rehabilitation training plus inspiratory muscle trainingExperimental Treatment2 Interventions

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.

Group II: 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory musclePlacebo Group2 Interventions

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.

0 / 5Eligibility criteria met