Increasing Activity in Liver Transplant Patients

April 28, 2016 updated by: Jennifer L. Serotta, A.R.N.P., Mayo Clinic

Increasing Physical Activity in Post Liver Transplant Patients

Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Adult patients 18-65 years of age who receive a liver transplant at Mayo Clinic Jacksonville.
  • Adult patients who are 5-21 days post liver transplant.
  • Must be followed by Mayo Clinic Jacksonville at 4 months postoperatively.
  • Approved by a hepatologist and/or transplant surgeon to participate.

Exclusion criteria:

  • Patients with active infections
  • Patients with encephalopathy or cognitive dysfunction
  • Patients who receive a combined liver-kidney transplant
  • Patients with severe debility
  • Patients who require assistance to ambulate.

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver Transplant Patients
Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.
Behavioral: Physical activity
Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, 6 weeks
The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).
Baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life at Baseline, 6 Weeks, and 4 Months
Time Frame: Baseline, 6 weeks, 4 months
Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.
Baseline, 6 weeks, 4 months
Number of Patients Who Document Their Physical Activity
Time Frame: Baseline to 6 weeks, repeated measure at 4 months
8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.
Baseline to 6 weeks, repeated measure at 4 months

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Jennifer Serotta, ARNP, Mayo Clinic

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

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-004699

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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