Liver Transplant
Conditions
Keywords
Liver transplant, Physical Activity, Quality of Life
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?
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life at Baseline, 6 Weeks, and 4 Months | 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. |
| Number of Patients Who Document Their Physical Activity | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at Mayo Clinic in Jacksonville, Florida. Data were collected from April 2014 to September 2014.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Liver Transplant Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Liver Transplant Patients | Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ) | Baseline | 407 MET |
| Liver Transplant Patients | Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ) | 6 weeks | 1711 MET |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Liver Transplant Patients | Number of Patients Who Document Their Physical Activity | 6 weeks | 8 participants |
| Liver Transplant Patients | Number of Patients Who Document Their Physical Activity | 4 months | 6 participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liver Transplant Patients | Quality of Life at Baseline, 6 Weeks, and 4 Months | 4 months | 8.3 units on a scale | Standard Deviation 1.6 |
| Liver Transplant Patients | Quality of Life at Baseline, 6 Weeks, and 4 Months | Baseline | 5.5 units on a scale | Standard Deviation 2.5 |
| Liver Transplant Patients | Quality of Life at Baseline, 6 Weeks, and 4 Months | 6 Weeks | 8.25 units on a scale | Standard Deviation 1.6 |
p-value: 0.27Wilcoxon (Mann-Whitney)