The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Glomerular filtration rate
Study Overview
Brief Summary
The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on cardiovascular risk factors, physical activity level, physical activity behavior, and gait parameters in kidney transplant recipients.
Detailed Description
The Transtheoretical Model evaluates readiness for behavior change. The Transtheoretical Model has been frequently used to determine how individuals adopt and maintain physical activity. In kidney transplant recipients (KTRs), increased physical activity level is associated with better graft function, and decreased physical activity is associated with increased cardiovascular and all-cause mortality. Therefore, it is important to evaluate the level of physical activity and to gain physical activity habits in KTRs. The aim of this study is to investigate the effects of physical activity program according to motivational interviewing based on the Transtheoretical Model on on cardiovascular risk factors, physical activity level, physical activity behavior, and gait parameters in KTRs.
28 KTRs who meet the inclusion criteria will be assigned to the physical activity program or control group by non-randomization method. In the physical activity group, a 12-weeks physical activity program will be applied by giving pedometer. 12 telephone sessions will be held once a week according to motivational interview techniques based on the Transtheoretical Model. Assessments will perform just before starting to study, at the end of 12 weeks (just after the physical activity program), and the end of 24 weeks. In the control group, information about physical activity will be given without applying the physical activity program. Control group's assessments will be performed when they are included in the study, at the end of 12 weeks and 24 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •to be at least 18 years old
- •to have had a kidney transplantation at least 6 months ago
Exclusion Criteria
- •Pregnancy
- •Multiple organ transplantation
- •Severe cognitive impairment (Mini Mental Test score less than 24)
- •Uncorrected visual impairment
- •Certain neurological pathology (parkinson, stroke, epilepsy)
- •Orthopedic surgery or injury to the lower extremity that will affect individuals' participation in daily life
- •Inability to walk independently
Arms & Interventions
Physical Activity Program Group
In the physical activity group, In the physical activity group, a 12-weeks physical activity program will be applied by giving pedometer. 12 telephone sessions will be held once a week according to motivational interview techniques based on the Transtheoretical Model. Assessments will perform just before starting to study, at the end of 12 weeks (just after the physical activity program), and the end of 24 weeks.
Intervention: Physical activity program (Other)
Control group
In the control group, information about physical activity will be given without applying the physical activity program. Control group's assessments will be performed when they are included in the study, at the end of 12 weeks and 24 weeks.
Outcomes
Primary Outcomes
Glomerular filtration rate
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
ml/dk/1.73m2
Blood Glucose
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mg/dL
HeartScore system
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Assess cardiovascular risk.
Blood pressure
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mmHg
Heart rate
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
beats per minute
Hemoglobin
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
g/dL
Body Mass Index
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Body Mass Index is weight in kilograms divided by height in meters squared. Formula: weight (kg) / \[height (m)\]2
Lipid profile
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
total cholesterol level, LDL and HDL cholesterol, triglyceride (mg/dL)
Waist circumference
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
centimeter
C-reactive protein
Time Frame: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mg/L
Secondary Outcomes
- Physical activity monitor (SenseWear Armband)(Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks)
- Exercise Stages of Change Questionnaire(Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks)
- G-Walk sensor system(Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks)
Investigators
Hatice Nihan BOZKURT
Research Assistant
Dokuz Eylul University