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Inspiratory Muscle Training Post-Liver Transplant

Primary Purpose

Liver Disease Chronic, Muscle Weakness, Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Disease Chronic focused on measuring liver disease, transplant, muscle wasting, breathing exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Miami Transplant Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inspiratory Muscle Training

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2017
Last Updated
June 18, 2021
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03130608
Brief Title
Inspiratory Muscle Training Post-Liver Transplant
Official Title
Comparison of Inspiratory Muscle Training and Usual Care in Individuals Post-Liver Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease Chronic, Muscle Weakness, Respiratory Insufficiency
Keywords
liver disease, transplant, muscle wasting, breathing exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Receive the usual post-liver transplant care of gradually increase their activity.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Maximal Inspiratory Pressure (MIP) at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks.
Title
Change from baseline Forced Expiratory Volume (FEV1) at 4 weeks and 8 weeks
Description
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.
Time Frame
Baseline, 4th week, and 8th week
Title
Change from baseline 6 Minute Walk Distance at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change from baseline 30 Second Chair Stand Repetitions at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change from baseline Chronic Liver Disease Questionnaire (CLDQ) Score at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change from baseline Karnovsky Performance Status Score at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change from baseline Sustained Maximal Inspiratory Pressure (SMIP) at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change from baseline Inspiratory Duration (ID) at 4 weeks and 8 weeks
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change from baseline Maximal Expiratory Pressure (MEP) at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, and 8 weeks
Title
Change from baseline Forced Vital Capacity (FVC) at 4 weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks.
Title
Change from baseline Forced Expiratory Flow (FEF25-75%) at 4weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks.
Title
Change from baseline Peak Expiratory Flow Rate (PEFR) at 4weeks and 8 weeks.
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Subjects must have undergone liver transplantation for chronic liver disease of any origin other than cancer. Exclusion Criteria: Severe cardiopulmonary disease such as recent Myocardial infarction, Congestive Heart Failure, Pulmonary edema, Chronic Obstructive Pulmonary Disease, and Asthma, Severe osteoarthritis Blindness Wheelchair bound individuals Individuals with neurological / neuromuscular disorders including but not limited to: cerebral vascular accident, Parkinsonism, Alzheimer's disease, dystonia, multiple sclerosis, and polio. Severe Cognitive impairment where individuals cannot follow commands and are unable to sign informed consent -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Mandel, PT, PhD
Organizational Affiliation
University of Miami Miller School of Medicine Department of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Transplant Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Inspiratory Muscle Training Post-Liver Transplant

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