Liver Disease ChronicNCT03130608
Inspiratory Muscle Training Post-Liver Transplant
A study testing Inspiratory Muscle Training in people with Liver Disease Chronic and Muscle Weakness, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease Chronic, Muscle Weakness, Respiratory Insufficiency
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Subjects must have undergone liver transplantation for chronic liver disease of any origin other than cancer.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Inspiratory Muscle Training
- Keywords
- liver disease, transplant, muscle wasting, breathing exercise
- Medical subject headings
- Muscle Weakness, Respiratory Insufficiency, Liver Diseases, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | 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. Receives: Other: Inspiratory Muscle Training |
| Usual Care | No intervention | Receive the usual post-liver transplant care of gradually increase their activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start30 Jun 2017
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David W. Mandel, University of Miami
- Investigators
- David W Mandel, PT, PhD, Principal investigator, University of Miami Miller School of Medicine Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130608
- Sponsor's protocol ID
- 20170229
- Status last verified
- Jun 2021
- First submitted
- 16 Mar 2017
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inspiratory Muscle Training and Usual Care in Individuals Post-Liver Transplant
- ClinicalTrials.gov ID
- NCT03130608
- Acronym / sponsor ID
- 20170229
- Keywords
- liver disease, transplant, muscle wasting, breathing exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Other: Inspiratory Muscle TrainingThe 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. |
| Usual Care | No intervention | –Receive the usual post-liver transplant care of gradually increase their activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Subjects must have undergone liver transplantation for chronic liver disease of any origin other than cancer.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingSubjects 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. | Other | Inspiratory Muscle Training |
Primary outcome
Change from baseline Maximal Inspiratory Pressure (MIP) at 4 weeks and 8 weeks.
Time frame: Baseline, 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
Time frame: Baseline, 4th week, and 8th week
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.
Time frame: Baseline, 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.
Time frame: Baseline, 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.
Time frame: Baseline, 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.
Time frame: Baseline, 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.
Time frame: Baseline, 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
Time frame: Baseline, 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.
Time frame: Baseline, 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.
Time frame: Baseline, 4 weeks, 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.
Time frame: Baseline, 4 weeks, 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.
Time frame: Baseline, 4 weeks, 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David W Mandel, PT, PhD principal investigator
University of Miami Miller School of Medicine Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Liver Disease Chronic and Muscle Weakness, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Maximal Inspiratory Pressure (MIP) at 4 weeks and 8 weeks. (time frame: Baseline, 4 weeks, and 8 weeks.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.