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

Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Lung Transplantation Bronchiectasis
• Intervention / Treatment: Device: POWERBreathe Plus®; Other: Cardiopulmonary rehabilitation post lung transplant

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic in Florida
      • Contact: Temetria Miller; Phone Number: 904-953-2000; Email: miller.temetria@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: POWERBreathe Plus®; Commercially available pressure-threshold device; Other: 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
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.	Device: POWERBreathe Plus®; Commercially available pressure-threshold device; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal inspiratory mouth pressure (MIP) measured in cmH2O	The maximal strength generating capacity of the inspiratory muscles.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal oxygen uptake (V̇O2max) measured in mL/kg/min	Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test distance (6MWTd) measured in meters (m)	Distance walked during a 6 minute test	12 weeks
Peak work rate (Wpeak) (watts)	The maximal work achieved in watts during a symptom limited exercise test.	12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bryan Taylor, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: breathing; exercise capacity; Inspiratory muscle training; post lung transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Bronchial Diseases; Bronchiectasis; Respiratory Aspiration
• Other Study ID Numbers: 20-012778

Drug and device information, study documents

• 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