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Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant

NCT ID: NCT01216722

Last Updated: 2010-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-07-31

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.

Conditions

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Liver Transplantation Resistance Training Activities of Daily Living

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Resistance Strengthening Exercise Program

Intervention Type OTHER

Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks

Usual Care Control

Subjects perform the usual care of progressive ambulation and increased activity post liver transplant

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Resistance Strengthening Exercise Program

Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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University of Miami Dept. of Physical Therapy

Principal Investigators

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Kathryn Roach, PhD, PT

Role: STUDY_CHAIR

University of Miami

David W Mandel, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University of Miami Dept. of Physical Therapy

Locations

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University of Miami Department of Physical Therapy

Coral Gables, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20070787

Identifier Type: -

Identifier Source: org_study_id