Inspiratory Muscle Training Post-Liver Transplant

NCT ID: NCT03130608

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2021-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inspiratory Muscle Training

The experimental group will perform Inspiratory Muscle Training (IMT) using a THRESHOLD device, a simple hand held one way valve.

In addition, the experimental group will gradually increase their activity as part of their usual care post-transplant.

Group Type: EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type: OTHER

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.

Usual Care

Receive the usual post-liver transplant care of gradually increase their activity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects must have undergone liver transplantation for chronic liver disease of any origin other than cancer.

Exclusion Criteria

1. Severe cardiopulmonary disease such as recent Myocardial infarction, Congestive Heart Failure, Pulmonary edema, Chronic Obstructive Pulmonary Disease, and Asthma,

2. Severe osteoarthritis

3. Blindness

4. Wheelchair bound individuals

5. Individuals with neurological / neuromuscular disorders including but not limited to: cerebral vascular accident, Parkinsonism, Alzheimer's disease, dystonia, multiple sclerosis, and polio.

6. Severe Cognitive impairment where individuals cannot follow commands and are unable to sign informed consent -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

David W. Mandel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David W Mandel, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami Miller School of Medicine Department of Physical Therapy

Locations

Miami Transplant Institute

Miami, Florida, United States

Countries

United States

Other Identifiers

20170229

Identifier Type: -

Identifier Source: org_study_id