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OpenTrials
Completed

NCT Number: NCT01216722

Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Department of Physical Therapy

Coral Gables, Florida, 44146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance Strengthening Exercise Program

Other

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

Primary outcomes

  1. Six Minute Walk Test

    Time frame: Baseline

  2. Heel Rise Test

    Time frame: Baseline

  3. 30-Second Chair-Stand Test

    Time frame: Baseline

  4. Bridge Test

    Time frame: Baseline

  5. Six Minute Walk Test

    Time frame: 12 weeks

  6. Heel Rise Test

    Time frame: 12 weeks

  7. 30-Second Chair-Stand Test

    Time frame: 12 weeks

  8. Bridge Test

    Time frame: 12 weeks

Secondary outcomes

  1. Short Form (SF-36) Questionnaire

    Time frame: Baseline

  2. Short Form (SF-36) Questionnaire

    Time frame: 12 weeks

  3. Chronic Liver Disease Questionnaire (CLDQ)

    Time frame: Baseline

  4. Chronic Liver Disease Questionnaire (CLDQ)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Oct 7, 2010
Registry last updated
Oct 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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