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

NCT04783155 | Recruiting FDA Device

• 1 other identifier: 20-012778
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Lung Transplantation Bronchiectasis

Keywords

Inspiratory muscle training; post lung transplant; exercise capacity; breathing

Outcome Measures

Primary Outcomes (1)

• Maximal inspiratory mouth pressure (MIP) measured in cmH2O

  The maximal strength generating capacity of the inspiratory muscles.

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Other Outcomes (2)

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

  12 weeks

• Peak work rate (Wpeak) (watts)

  12 weeks

Study Arms (2)

12-weeks pulmonary rehabilitation training plus inspiratory muscle training

EXPERIMENTAL

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®; Other: Cardiopulmonary rehabilitation post lung transplant

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

PLACEBO COMPARATOR

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®; Other: Cardiopulmonary rehabilitation post lung transplant

Interventions

Cardiopulmonary rehabilitation post lung transplant OTHER

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

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

POWERBreathe Plus® DEVICE

Commercially available pressure-threshold device

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bryan Taylor, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bryan Taylor

CONTACT

taylor.bryan@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blinded, randomized study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 5, 2021
• Study Start: May 10, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)