Trial Outcomes & Findings for Increasing Activity in Liver Transplant Patients (NCT NCT02058498)

NCT ID: NCT02058498

Last Updated: 2016-06-06

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Baseline, 6 weeks

Results posted on

2016-06-06

Participant Flow

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

Participant milestones

Participant milestones
Measure	Liver Transplant Patients 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 Study STARTED	12
Overall Study 6 Weeks	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Liver Transplant Patients 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 Study Withdrawal by Subject	4

Baseline Characteristics

Increasing Activity in Liver Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liver Transplant Patients n=12 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Outcome measures

Outcome measures
Measure	Liver Transplant Patients n=8 Participants 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.
Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ) Baseline	407 MET Interval 99.0 to
Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ) 6 weeks	1711 MET Interval 462.0 to 2479.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liver Transplant Patients n=8 Participants 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.
Quality of Life at Baseline, 6 Weeks, and 4 Months Baseline	5.5 units on a scale Standard Deviation 2.5
Quality of Life at Baseline, 6 Weeks, and 4 Months 6 Weeks	8.25 units on a scale Standard Deviation 1.6
Quality of Life at Baseline, 6 Weeks, and 4 Months 4 months	8.3 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liver Transplant Patients n=8 Participants 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.
Number of Patients Who Document Their Physical Activity 6 weeks	8 participants
Number of Patients Who Document Their Physical Activity 4 months	6 participants

Adverse Events

Liver Transplant Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Serotta, DNP, ARNP

Mayo Clinic Jacksonville

Phone: 904-956-3200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place