Back to resultsEffect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant
Primary Purpose
Post-Lung Transplantation Bronchiectasis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POWERBreathe Plus®
Cardiopulmonary rehabilitation post lung transplant
Sponsored by
About this trial
This is an interventional supportive care trial for Post-Lung Transplantation Bronchiectasis focused on measuring Inspiratory muscle training, post lung transplant, exercise capacity, breathing
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
12-weeks pulmonary rehabilitation training plus inspiratory muscle training
12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle
Arm 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.
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.
Outcomes
Primary Outcome Measures
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
The maximal strength generating capacity of the inspiratory muscles.
Secondary Outcome Measures
Maximal oxygen uptake (V̇O2max) measured in mL/kg/min
Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04783155
Brief Title
Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant
Official Title
Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Lung Transplantation Bronchiectasis
Keywords
Inspiratory muscle training, post lung transplant, exercise capacity, breathing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This is a double-blinded, randomized study
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
12-weeks pulmonary rehabilitation training plus inspiratory muscle training
Arm Type
Experimental
Arm 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.
Arm Title
12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
POWERBreathe Plus®
Intervention Description
Commercially available pressure-threshold device
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary rehabilitation post lung transplant
Intervention Description
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 Information:
Title
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
Description
The maximal strength generating capacity of the inspiratory muscles.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Maximal oxygen uptake (V̇O2max) measured in mL/kg/min
Description
Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Six-minute walk test distance (6MWTd) measured in meters (m)
Description
Distance walked during a 6 minute test
Time Frame
12 weeks
Title
Peak work rate (Wpeak) (watts)
Description
The maximal work achieved in watts during a symptom limited exercise test.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Taylor, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Temetria Miller
Phone
904-953-2000
Email
miller.temetria@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant
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