Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant

October 6, 2010 updated by: University of Miami

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 44146
        • University of Miami Department of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

October 7, 2010

Last Update Submitted That Met QC Criteria

October 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20070787

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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