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Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant

This study has been completed.
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01216722
First received: October 6, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


Condition Intervention
Liver Transplantation
Resistance Training
Activities of Daily Living
 Other: Resistance Strengthening Exercise Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Targeted Lower Extremity Strengthening and Usual Care Progressive Ambulation in Subjects Post Liver Transplant: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Six Minute Walk Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Heel Rise Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 30-Second Chair-Stand Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Bridge Test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Six Minute Walk Test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Heel Rise Test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 30-Second Chair-Stand Test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Bridge Test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short Form (SF-36) Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Short Form (SF-36) Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Chronic Liver Disease Questionnaire (CLDQ) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Chronic Liver Disease Questionnaire (CLDQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2007
Study Completion Date: July 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistance Strengthening
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
Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks
No Intervention: Usual Care Control
Subjects perform the usual care of progressive ambulation and increased activity post liver transplant

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216722

Locations
United States, Florida
University of Miami Department of Physical Therapy
Coral Gables, Florida, United States, 44146
Sponsors and Collaborators
University of Miami
Investigators
Study Chair: Kathryn Roach, PhD, PT University of Miami
Principal Investigator: David W Mandel, PhD, PT University of Miami Dept. of Physical Therapy
  More Information

No publications provided

Responsible Party: David Mandel, Investigator, University of Miami Dept. of Physical Therapy
ClinicalTrials.gov Identifier: NCT01216722     History of Changes
Other Study ID Numbers: 20070787
Study First Received: October 6, 2010
Last Updated: October 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Muscle Wasting
Strengthening
Liver Disease
Transplant

ClinicalTrials.gov processed this record on May 23, 2013