Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant

Study Overview
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Brief Summary
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Resistance strengthening exercise will increase strength and functional activity greater than ambulation in subjects post-liver transplantation.

Detailed Description
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Individuals post liver transplantation are significantly muscle wasted due to chronic liver disease. Current Usual care only involves progressive ambulation. Resistance exercise targeted at the lower extremities are anticipated to increase muscle strength in the muscles that extend the hip, extend the knee, and plantar flex the ankle more than seen with the usual care ambulation. The anticipated increases in strength should improve functional performance of activities such as standing from a chair, walking, and climbing stairs. The improvement in strength and functional performance should improve an individuals quality of life.

Official Title
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Comparison of Targeted Lower Extremity Strengthening and Usual Care Progressive Ambulation in Subjects Post Liver Transplant: A Randomized Controlled Trial

Conditions
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Liver Transplantation, Resistance Training, Activities of Daily Living

Intervention / Treatment
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* Other: Resistance Strengthening Exercise Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergone Liver Transplantation a minimum of 6 weeks and a maximum of 12 weeks prior to enrollment Ambulatory without physical assistance, but permitted to use a cane or walker Exclusion Criteria: Diagnosis of Hepatocellular Carcinoma Significant Cardiopulmonary disease Neurological / Neuromuscular Disorder including cerebral vascular accident (CVA), Parkinson's Disease, Alzheimer's Disease, Dementia unrelated to Hepatic Encephalopathy, dystonia, multiple sclerosis, and polio. Blindness Inability to comprehend the English or Spanish Language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance Strengthening<br>Body weight antigravity positioning and elastic resistance bands are used to provide resistance for strengthening in supine, sitting, and standing in subjects post liver transplant. | Other: Resistance Strengthening Exercise Program<br>* Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks<br>|
| No Intervention: Usual Care Control<br>Subjects perform the usual care of progressive ambulation and increased activity post liver transplant | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test |  | Baseline | 
| Heel Rise Test |  | Baseline | 
| 30-Second Chair-Stand Test |  | Baseline | 
| Bridge Test |  | Baseline | 
| Six Minute Walk Test |  | 12 weeks | 
| Heel Rise Test |  | 12 weeks | 
| 30-Second Chair-Stand Test |  | 12 weeks | 
| Bridge Test |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form (SF-36) Questionnaire |  | Baseline | 
| Short Form (SF-36) Questionnaire |  | 12 weeks | 
| Chronic Liver Disease Questionnaire (CLDQ) |  | Baseline | 
| Chronic Liver Disease Questionnaire (CLDQ) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle Wasting, Strengthening, Liver Disease, Transplant