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NCT Number: NCT04783155

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

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.

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Key information

Conditions

Post-Lung Transplantation Bronchiectasis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

POWERBreathe Plus®

Device

Commercially available pressure-threshold device

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

Primary outcomes

  1. Maximal inspiratory mouth pressure (MIP) measured in cmH2O

    Time frame: 12 weeks

    The maximal strength generating capacity of the inspiratory muscles.

Secondary outcomes

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

    Time frame: 12 weeks

    Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test.

Other outcomes

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

    Time frame: 12 weeks

    Distance walked during a 6 minute test

  2. Peak work rate (Wpeak) (watts)

    Time frame: 12 weeks

    The maximal work achieved in watts during a symptom limited exercise test.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2021
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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