Inspiratory Muscle Training Post-Liver Transplant

Comparison of Inspiratory Muscle Training and Usual Care in Individuals Post-Liver Transplant

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Respiratory Insufficiency; Liver Disease Chronic
• Intervention / Treatment: Other: Inspiratory Muscle Training

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Miami Transplant Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Usual Care; Receive the usual post-liver transplant care of gradually increase their activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Maximal Inspiratory Pressure (MIP) at 4 weeks and 8 weeks.	MIP is a measure of inspiratory muscle strength . Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing. Each measurement will be performed 3 times with the maximal score recorded.	Baseline, 4 weeks, and 8 weeks.
Change from baseline Forced Expiratory Volume (FEV1) at 4 weeks and 8 weeks	FEV1 is how much air can be exhaled during a forced exhalation at one second. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing. Each measurement will be performed 3 times with the maximal score recorded.	Baseline, 4th week, and 8th week
Change from baseline 6 Minute Walk Distance at 4 weeks and 8 weeks.	In a 100ft. straight hallway the subject will walk back and forth, from one end to the other, as many times as they can in 6 minutes. The subject will have the option to rest at any time during the six minutes. The clock will keep running whether the subject is walking or resting. The subject will be provided standardized cues to prevent unequal encouragement. The distance walked over the 6 minutes will be recorded. Throughout the walking test, the investigator will be walking nearby to guard patient from loss of balance or fall.	Baseline, 4 weeks, and 8 weeks
Change from baseline 30 Second Chair Stand Repetitions at 4 weeks and 8 weeks.	From a straight back chair the subject will come to a complete stand and then return to sitting with arms across chest. The number of times the subject can stand in 30 seconds will be recorded. The investigator will be standing nearby guarding the subject to protect from any loss of balance or fall.	Baseline, 4 weeks, and 8 weeks
Change from baseline Chronic Liver Disease Questionnaire (CLDQ) Score at 4 weeks and 8 weeks.	This is a paper and pencil questionnaire consisting of 29 items in 6 domains: 1) Abdominal Symptoms 2) Activity: eating habits and movement of heavy objects 3) Emotional Function 4) Fatigue: perception of decreased energy and sleepiness 5) Systemic symptoms 6) Worry: concerns regarding disease progression and family. Summary scores for each domain range from 1(most impaired) to 7 (least impaired). All items refer to the previous 2 weeks. Higher scores indicate less impairment.	Baseline, 4 weeks, and 8 weeks
Change from baseline Karnovsky Performance Status Score at 4 weeks and 8 weeks.	This is a paper pencil questionnaire measuring functional impairment. The questionnaire is divided into three groups for classifying patient's ability to work, to carry on normal activity, and to care for themselves. The groups are further divided into eleven categories covering all level so functioning from normal (100) to dead (0). The lower the Karnovsky score, the worse the functional ability and survival for most serious illness. The liver transplant team records this measure prior to transplant. We will obtained pre-transplant scores from medical record for use in correlational analysis. This measure will also performed at baseline and post-testing.	Baseline, 4 weeks, and 8 weeks
Change from baseline Sustained Maximal Inspiratory Pressure (SMIP) at 4 weeks and 8 weeks.	SMIP will be measured from residual volume to total lung capacity representing single breath work/endurance. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.	Baseline, 4 weeks, and 8 weeks
Change from baseline Inspiratory Duration (ID) at 4 weeks and 8 weeks	ID is the inspiratory flow during maximal inspiration effort with an isokinetic like resistance from the mouthpiece. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.	Baseline, 4 weeks, and 8 weeks
Change from baseline Maximal Expiratory Pressure (MEP) at 4 weeks and 8 weeks.	MEP is a measure of expiratory muscle strength measured from total lung capacity. Inspiratory testing will be performed using a Micro Mouth Pressure Manometer. 92887) Measurements will be performed in the testing position with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing.	Baseline, 4 weeks, and 8 weeks
Change from baseline Forced Vital Capacity (FVC) at 4 weeks and 8 weeks.	FVC is the total amount of air exhaled during a pulmonary function test. Expiratory testing will be performed using the Jones Satellite Spirometer (Jones Medical Instrument Company, Oakbrook, Illinois 65021) Measurements will be performed in the manner described using American Thoracic Society guidelines with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing. Each measurement will be performed 3 times with the maximal score recorded.	Baseline, 4 weeks, 8 weeks.
Change from baseline Forced Expiratory Flow (FEF25-75%) at 4weeks and 8 weeks.	FEF25-75% is the flow rate at 25% to 75% of Forced Vital Capacity. Expiratory testing will be performed using the Jones Satellite Spirometer (Jones Medical Instrument Company, Oakbrook, Illinois 65021) Measurements will be performed in the manner described using American Thoracic Society guidelines with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing. Each measurement will be performed 3 times with the maximal score recorded.	Baseline, 4 weeks, 8 weeks.
Change from baseline Peak Expiratory Flow Rate (PEFR) at 4weeks and 8 weeks.	PEFR is a measure of how fast a person can exhale. Expiratory testing will be performed using the Jones Satellite Spirometer (Jones Medical Instrument Company, Oakbrook, Illinois 65021) Measurements will be performed in the manner described using American Thoracic Society guidelines with subjects in the seated position and the trunk at a 90 degree angle to the hips. Subjects will wear a nose clip during testing. Each measurement will be performed 3 times with the maximal score recorded.	Baseline, 4 weeks, 8 weeks.

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: David W Mandel, PT, PhD, University of Miami Miller School of Medicine Department of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: transplant; liver disease; muscle wasting; breathing exercise
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Liver Diseases; Muscle Weakness; Respiratory Insufficiency
• Other Study ID Numbers: 20170229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No