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Increasing Activity in Liver Transplant Patients

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ClinicalTrials.gov Identifier: NCT02058498
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Jennifer L. Serotta, A.R.N.P., Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Liver Transplant Behavioral: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Increasing Physical Activity in Post Liver Transplant Patients
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058498


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jennifer Serotta, ARNP Mayo Clinic

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Responsible Party: Jennifer L. Serotta, A.R.N.P., ARNP, FNP-BC, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02058498     History of Changes
Other Study ID Numbers: 13-004699
First Posted: February 10, 2014    Key Record Dates
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016
Last Verified: April 2016

Keywords provided by Jennifer L. Serotta, A.R.N.P., Mayo Clinic:
Liver transplant
Physical Activity
Quality of Life