CClinicalTrials.gg
CompletedNCT02058498Updated Jun 6, 2016Results posted

Increasing Activity in Liver Transplant Patients

An interventional study of Physical activity in Liver Transplant, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-06-06.

Sponsored by Mayo Clinic · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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?

02

Conditions studied

  • Liver Transplant

Keywords

  • Liver transplant
  • Physical Activity
  • Quality of Life
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralPhysical 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.

06

What researchers measure

Primary outcomes

  1. Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)

    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).

    Time frame: Baseline, 6 weeks

Secondary outcomes

  1. Quality of Life at Baseline, 6 Weeks, and 4 Months

    Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.

    Time frame: Baseline, 6 weeks, 4 months

  2. Number of Patients Who Document Their Physical Activity

    8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.

    Time frame: Baseline to 6 weeks, repeated measure at 4 months

07

Results

Posted Jun 6, 2016

Participant flow

Participants were enrolled at Mayo Clinic in Jacksonville, Florida. Data were collected from April 2014 to September 2014.

Participant flow — Overall Study
MilestoneLiver Transplant Patients
Started12
6 weeks8
Completed8
Not completed4
Withdrew: Withdrawal by subject4

Outcome measures

PrimaryPhysical Activity Measured by the International Physical Activity Questionnaire (IPAQ)

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).

Time frame:
Baseline, 6 weeks
Reported as:
Median · MET
Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)
METLiver Transplant Patients
Baseline407 (99 to 14,826)
6 weeks1711 (462 to 2479)
SecondaryQuality of Life at Baseline, 6 Weeks, and 4 Months

Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.

Time frame:
Baseline, 6 weeks, 4 months
Reported as:
Mean · units on a scale
Quality of Life at Baseline, 6 Weeks, and 4 Months
units on a scaleLiver Transplant Patients
Baseline5.5 ± 2.5
6 Weeks8.25 ± 1.6
4 months8.3 ± 1.6
Statistical analysis
  • Liver Transplant Patients · Wilcoxon (Mann-Whitney) · p = 0.27
SecondaryNumber of Patients Who Document Their Physical Activity

8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.

Time frame:
Baseline to 6 weeks, repeated measure at 4 months
Reported as:
Number · participants
Number of Patients Who Document Their Physical Activity
participantsLiver Transplant Patients
6 weeks8
4 months6

Adverse events

Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liver Transplant Patients—0/12 (0%)0/12 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Liver Transplant Patients
<=18 years0
Between 18 and 65 years12
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Liver Transplant Patients
Female2
Male10
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Liver Transplant Patients
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White10
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Liver Transplant Patients
United States12
08

Study locations

1 site
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02058498
Lead sponsor
Mayo Clinic
Responsible party
Jennifer L. Serotta, A.R.N.P. (ARNP, FNP-BC, Mayo Clinic) — Principal investigator
First posted
Feb 10, 2014
Start date
Feb 2014
Primary completion
Dec 2014
Completion
Dec 2014
Results posted
Jun 6, 2016
Last update
Jun 6, 2016

Study contacts

Jennifer Serotta, ARNP
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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