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OpenTrials
Completed

NCT Number: NCT02058498

Increasing Activity in 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?

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Key information

Conditions

Liver Transplant Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Physical activity

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Increasing Physical Activity in Post Liver Transplant Patients

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 10, 2014
Registry last updated
Jun 6, 2016

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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