Clinical trial NCT03130608: Inspiratory Muscle Training Post-Liver Transplant
Official title: Comparison of Inspiratory Muscle Training and Usual Care in Individuals Post-Liver Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Disease Chronic
Muscle Weakness
Respiratory Insufficiency
Keywords: liver disease
transplant
muscle wasting
breathing exercise
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 -

Primary outcomes:
measure: Change from baseline Maximal Inspiratory Pressure (MIP) at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, and 8 weeks.
measure: Change from baseline Forced Expiratory Volume (FEV1) at 4 weeks and 8 weeks
timeFrame: Baseline, 4th week, and 8th week
measure: Change from baseline 6 Minute Walk Distance at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change from baseline 30 Second Chair Stand Repetitions at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change from baseline Chronic Liver Disease Questionnaire (CLDQ) Score at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change from baseline Karnovsky Performance Status Score at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change from baseline Sustained Maximal Inspiratory Pressure (SMIP) at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change from baseline Inspiratory Duration (ID) at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change from baseline Maximal Expiratory Pressure (MEP) at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change from baseline Forced Vital Capacity (FVC) at 4 weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, 8 weeks.
measure: Change from baseline Forced Expiratory Flow (FEF25-75%) at 4weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, 8 weeks.
measure: Change from baseline Peak Expiratory Flow Rate (PEFR) at 4weeks and 8 weeks.
timeFrame: Baseline, 4 weeks, 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Transplant Institute
state: Florida
Study officials:
affiliation: University of Miami Miller School of Medicine Department of Physical Therapy
name: David W Mandel, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: