Clinical trial NCT01216722: Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant
Official title: Comparison of Targeted Lower Extremity Strengthening and Usual Care Progressive Ambulation in Subjects Post Liver Transplant: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Resistance Training
Activities of Daily Living
Keywords: Muscle Wasting
Strengthening
Liver Disease
Transplant
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Six Minute Walk Test
timeFrame: Baseline
measure: Heel Rise Test
timeFrame: Baseline
measure: 30-Second Chair-Stand Test
timeFrame: Baseline
measure: Bridge Test
timeFrame: Baseline
measure: Six Minute Walk Test
timeFrame: 12 weeks
measure: Heel Rise Test
timeFrame: 12 weeks
measure: 30-Second Chair-Stand Test
timeFrame: 12 weeks
measure: Bridge Test
timeFrame: 12 weeks
Secondary outcomes:
measure: Short Form (SF-36) Questionnaire
timeFrame: Baseline
measure: Short Form (SF-36) Questionnaire
timeFrame: 12 weeks
measure: Chronic Liver Disease Questionnaire (CLDQ)
timeFrame: Baseline
measure: Chronic Liver Disease Questionnaire (CLDQ)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami Department of Physical Therapy
state: Florida
Study officials:
affiliation: University of Miami
name: Kathryn Roach, PhD, PT
role: STUDY_CHAIR
affiliation: University of Miami Dept. of Physical Therapy
name: David W Mandel, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: