The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- HeartScore system
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to be at least 18 years old
- •to have had a kidney transplantation at least 6 months ago
排除标准
- •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
结局指标
主要结局
HeartScore system
时间窗: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
Assess cardiovascular risk.
Blood pressure
时间窗: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mmHg
Heart rate
时间窗: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
beats per minute
Hemoglobin
时间窗: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
g/dL
Body Mass Index
时间窗: 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
时间窗: 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
时间窗: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
centimeter
C-reactive protein
时间窗: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mg/L
Glomerular filtration rate
时间窗: 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
时间窗: Change from Baseline at 12 weeks, change from Baseline at 24 weeks, change from 12 weeks at 24 weeks
mg/dL
次要结局
- 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)
研究者
Hatice Nihan BOZKURT
Research Assistant
Dokuz Eylul University