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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04783155

Enrollment

Registered

2021-03-05

Start date

2021-05-10

Completion date

2027-12-31

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Lung Transplantation Bronchiectasis

Keywords

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

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.

Interventions

DEVICEPOWERBreathe Plus®

Commercially available pressure-threshold device

OTHERCardiopulmonary 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Masking description

This is a double-blinded, randomized study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

United States

Contacts

Primary ContactBryan Taylor

taylor.bryan@mayo.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026