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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I had a lung transplant at Mayo Clinic Florida.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximal inspiratory mouth pressure (MIP) measured in cmH2O

Secondary outcome measures

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

Other outcome measures

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,233 Previous Clinical Trials

3,772,031 Total Patients Enrolled

3 Trials studying Bronchiectasis

175 Patients Enrolled for Bronchiectasis

Bryan Taylor, PhDPrincipal Investigator - Mayo Clinic

Mayo Clinic

2 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Bronchiectasis

50 Patients Enrolled for Bronchiectasis

Media Library

Bronchiectasis Research Study Groups: 12-weeks pulmonary rehabilitation training plus inspiratory muscle training, 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle

Cardiopulmonary rehabilitation post lung transplant 2023 Treatment Timeline for Medical Study. Trial Name: NCT04783155 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment to this experiment still open?

"The information found on clinicaltrials.gov confirms that this trial is actively recruiting patients. This experiment was first posted to the site on May 10th, 2021 and its most recent update occured on December 5th of 2022."

Answered by AI

How many participants have registered for the experiment thus far?

"Affirmative, according to clinicaltrials.gov this medical experiment is still open for enrolment. It was first posted on May 10th 2021 and has recently been updated in December 5th 2022. The researchers are aiming to recruit 30 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Bryan Taylor 2021. "Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04783155.

All > Bronchiectasis