The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
- Conditions
- Kidney Transplant Recipients
- Interventions
- Other: Physical activity program
- Registration Number
- NCT05425498
- Lead Sponsor
- Dokuz Eylul University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- to be at least 18 years old
- to have had a kidney transplantation at least 6 months ago
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical Activity Program Group Physical activity program 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.
- Primary Outcome Measures
Name Time Method HeartScore system Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks Assess cardiovascular risk.
Blood pressure Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks mmHg
Heart rate Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks beats per minute
Hemoglobin Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks g/dL
Body Mass Index 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 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 Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks centimeter
C-reactive protein Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks mg/L
Glomerular filtration rate 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 Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks mg/dL
- Secondary Outcome Measures
Name Time Method Physical activity monitor (SenseWear Armband) Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks Assess physical activity. Number of steps, total energy expenditure (calories), day and night average sleep time (minutes), day and night average lying time (minutes), average metabolic equivalent (MET), energy expenditure consumed during moderate-intensity (3 MET) physical activity (calories), physical activity time (minutes, 3 METs) results are obtained.
Exercise Stages of Change Questionnaire Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks Determines stages of physical activity behavior change. These stages of behaviour change consist of precontemplation, contemplation, preparation, action and maintenance.
G-Walk sensor system Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks Assess gait parameters. Gait parameters include gait speed (meters per second) and cadence (steps per minute).
Trial Locations
- Locations (1)
Dokuz Eylül University
🇹🇷İzmir, Turkey