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

Post-Lung Transplantation Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783155
• Other study ID #: 20-012778
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Post-Lung Transplantation Bronchiectasis
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Six-minute walk test distance (6MWTd) measured in meters (m)	Distance walked during a 6 minute test	12 weeks
Other	Peak work rate (Wpeak) (watts)	The maximal work achieved in watts during a symptom limited exercise test.	12 weeks
Primary	Maximal inspiratory mouth pressure (MIP) measured in cmH2O	The maximal strength generating capacity of the inspiratory muscles.	12 weeks
Secondary	Maximal oxygen uptake (V?O2max) measured in mL/kg/min	Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test.	12 weeks

External Links

•   Mayo Clinic Clinical Trials