The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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, physical activity barriers and gait parameters in kidney transplant recipients.

Detailed Description
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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, physical activity barriers and gait parameters in KTRs. 30 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.

Official Title
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The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients

Conditions
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Kidney Transplant Recipients

Intervention / Treatment
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* Other: Physical activity program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Program Group<br>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. | Other: Physical activity program<br>* 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.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HeartScore system | Assess cardiovascular risk. | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Blood pressure | mmHg | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Heart rate | beats per minute | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Hemoglobin | g/dL | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Body Mass Index | Body Mass Index is weight in kilograms divided by height in meters squared. Formula: weight (kg) / [height (m)]2 | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Lipid profile | total cholesterol level, LDL and HDL cholesterol, triglyceride (mg/dL) | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Waist circumference | centimeter | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| C-reactive protein | mg/L | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Glomerular filtration rate | ml/dk/1.73m2 | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Proteinuria | mg/dL | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Blood Glucose | mg/dL | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity monitor (SenseWear Armband) | 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. | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| International Physical Activity Questionnaire - Long form | Assess physical activity level. Category 1 Low: <600 MET-min/week. Category 2 Moderate: 600-3000 MET-min/week, Category 3 High: >3000 MET- min/week. | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Exercise Stages of Change Questionnaire | Determines stages of physical activity behavior change. These stages of behaviour change consist of precontemplation, contemplation, preparation, action and maintenance. | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| Exercise Benefits/Obstacles Scale | Assess Physical activity barriers. The total score ranges from 43 to 172. The higher the total scale score, the more the individual understands the benefits of exercise. | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks | 
| G-Walk sensor system | Assess gait parameters. Gait parameters include gait speed (meters per second), cadence (steps per minute), stride length (meters), stride time (seconds), stance time (percent of gait cycle), swing time (percent of gait cycle), double support (percent of gait cycle), single support (percent of gait cycle) and pelvic angles during walking (degrees) | Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks |