Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216722
• Other study ID #: 20070787
• Status: Completed
• Phase: N/A
• First received: October 6, 2010
• Last updated: October 6, 2010
• Start date: October 2007
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Activities of Daily Living
• Liver Transplantation
• Resistance Training

Intervention

Other:
• Resistance Strengthening Exercise Program
Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks

Locations

Country	Name	City	State
United States	University of Miami Department of Physical Therapy	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six Minute Walk Test		Baseline	No
Primary	Heel Rise Test		Baseline	No
Primary	30-Second Chair-Stand Test		Baseline	No
Primary	Bridge Test		Baseline	No
Primary	Six Minute Walk Test		12 weeks	No
Primary	Heel Rise Test		12 weeks	No
Primary	30-Second Chair-Stand Test		12 weeks	No
Primary	Bridge Test		12 weeks	No
Secondary	Short Form (SF-36) Questionnaire		Baseline	No
Secondary	Short Form (SF-36) Questionnaire		12 weeks	No
Secondary	Chronic Liver Disease Questionnaire (CLDQ)		Baseline	No
Secondary	Chronic Liver Disease Questionnaire (CLDQ)		12 weeks	No