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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01216722 |
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Date of registration:
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06/10/2010 |
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Primary sponsor: |
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Public title:
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Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant
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Scientific 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 |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01216722 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kathryn Roach, PhD, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami |
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Name:
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David W Mandel, PhD, PT |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Miami Dept. of Physical Therapy |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Activities of Daily Living
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Liver Transplantation
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Resistance Training
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Intervention(s)
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Other: Resistance Strengthening Exercise Program
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Primary Outcome(s)
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30-Second Chair-Stand Test
[Time Frame: 12 weeks]
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30-Second Chair-Stand Test
[Time Frame: Baseline]
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Bridge Test
[Time Frame: 12 weeks]
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Bridge Test
[Time Frame: Baseline]
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Heel Rise Test
[Time Frame: 12 weeks]
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Heel Rise Test
[Time Frame: Baseline]
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Six Minute Walk Test
[Time Frame: 12 weeks]
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Six Minute Walk Test
[Time Frame: Baseline]
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Secondary Outcome(s)
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Chronic Liver Disease Questionnaire (CLDQ)
[Time Frame: 12 weeks]
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Chronic Liver Disease Questionnaire (CLDQ)
[Time Frame: Baseline]
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Short Form (SF-36) Questionnaire
[Time Frame: 12 weeks]
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Short Form (SF-36) Questionnaire
[Time Frame: Baseline]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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