Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: POWERBreathe Plus®, Cardiopulmonary rehabilitation post lung transplant.
- Who it may be relevant to
- Registry conditions: Post-Lung Transplantation Bronchiectasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial
Overview
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
- 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
Primary outcome measures
- Maximal inspiratory mouth pressure (MIP) measured in cmH2O [Time frame: 12 weeks]
Secondary outcome measures (1)
- Maximal oxygen uptake (V̇O2max) measured in mL/kg/min [Time frame: 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT04783155 · 20-012778