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Exercise Intervention in Liver Transplant Patients

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Liver Cirrhoses
End Stage Liver Disease
Sarcopenia

Treatments

Behavioral: Exercise Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02367092
14-14783

Details and patient eligibility

About

The purpose of this study is to learn more about the effects of exercise on functional status and outcomes on patients with end-stage liver disease on the liver transplant waiting list and who have undergone liver transplantation.

Full description

This study aims to evaluate the effects of a home-based exercise intervention on outcomes in liver transplant candidates and recipients. This home-based intervention consists of a 30-minute exercise session available on digital video disc or on the internet. This intervention was originally developed to improve functional status in community-dwelling older adults and therefore, has been designed to maximize the safety for even the most frail individuals. Subjects enrolled in this study will be randomized to one of two arms: (a) the exercise intervention arm in which the subjects will be asked perform this exercise session three to four times per week or (b) the standard-of-care arm in which the patient will be encouraged to exercise by their transplant clinician at every clinic visit. Subjects in the exercise intervention arm will undergo this intervention for 6 months. All subjects will be followed for up to two years from the time of enrollment to ascertain outcomes.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult (>=18 years of age)
  • Listed for liver transplantation or post-liver transplantation
  • English speaking

Exclusion criteria

  • Contraindications to weight-bearing exercise
  • Non-English speaking
  • Requires an assistive device for ambulation
  • Active hepatic encephalopathy at the time of baseline assessment for enrollment in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

83 participants in 2 patient groups

Exercise Program
Experimental group
Description:
The exercise intervention consists of a 30 minute exercise session led by an instructor through a DVD or a video available on the internet.
Treatment:
Behavioral: Exercise Program
Standard of care
No Intervention group
Description:
Standard of care which consists of encouragement to exercise by the subject's transplant clinician.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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