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Inspiratory Muscle Training Post-Liver Transplant

NCT03130608 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-06-21

No results posted yet for this study

Summary

Individuals with chronic liver disease develop significant muscle wasting that remains post-liver transplant. The transplant surgery additionally challenges respiratory mechanics. Respiratory muscle strength has been measured to be impaired in individuals post liver transplant. This study proposes an 8 week intervention designed to increase respiratory muscle strength and pulmonary function that we hypothesize will correlate to improved functional performance and quality of life post-liver transplant.

Pre-test post-test design, that will randomize subjects into an experimental group that will receive the inspiratory muscle strengthening exercise in addition to usual post-liver transplant care and a control group that will only receive the usual post-transplant care.

Up to 50 subjects will be recruited from the Post-Liver Transplant Outpatient Clinic at the Miami Transplant Institute.

The subjects will have repeated measurements of respiratory muscle strength, pulmonary function, functional mobility performance, and quality of life at baseline, 4 weeks, and 8 weeks.

Conditions

  • Liver Disease Chronic
  • Muscle Weakness
  • Respiratory Insufficiency

Interventions

OTHER

Inspiratory Muscle Training

Subjects will breath through a hand held valve that has adjustable resistance to strengthen the muscles used for breathing. Subjects will perform the exercise approximately 20-30 minutes, twice a day for 8 weeks.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • David W Mandel, PT, PhD · University of Miami Miller School of Medicine Department of Physical Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03130608 on ClinicalTrials.gov