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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Liver Transplant
Intervention Behavioral: Physical activity
Enrollment 12
Recruitment Details Participants were enrolled at Mayo Clinic in Jacksonville, Florida. Data were collected from April 2014 to September 2014.
Pre-assignment Details  
Arm/Group Title Liver Transplant Patients
Hide Arm/Group Description

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.

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.

Period Title: Overall Study
Started 12
6 Weeks 8
Completed 8
Not Completed 4
Reason Not Completed
Withdrawal by Subject             4
Arm/Group Title Liver Transplant Patients
Hide Arm/Group Description

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.

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.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
2
  16.7%
Male
10
  83.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   8.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liver Transplant Patients
Hide Arm/Group Description:

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.

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.

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: MET
Baseline
407
(99 to 14,826)
6 weeks
1711
(462 to 2479)
2.Secondary Outcome
Title Quality of Life at Baseline, 6 Weeks, and 4 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liver Transplant Patients
Hide Arm/Group Description:

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.

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.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 5.5  (2.5)
6 Weeks 8.25  (1.6)
4 months 8.3  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liver Transplant Patients
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Who Document Their Physical Activity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liver Transplant Patients
Hide Arm/Group Description:

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.

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.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
6 weeks 8
4 months 6
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liver Transplant Patients
Hide Arm/Group Description

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.

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.

All-Cause Mortality
Liver Transplant Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liver Transplant Patients
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liver Transplant Patients
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jennifer Serotta, DNP, ARNP
Organization: Mayo Clinic Jacksonville
Phone: 904-956-3200
Responsible Party: Jennifer L. Serotta, A.R.N.P., Mayo Clinic
ClinicalTrials.gov Identifier: NCT02058498     History of Changes
Other Study ID Numbers: 13-004699
First Submitted: February 4, 2014
First Posted: February 10, 2014
Results First Submitted: May 3, 2015
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016