Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
The Effect of Walking Exercise Training Based on the Theoretical Model on Adherence to Disease Management and Metabolic Control in Type 2 Diabetes Patients: A Clinical Randomized Controlled Study
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Gulengul Mermer, Ph.D
- 电话号码：+902323115536
- 邮箱：gulengulmermer@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients who diagnosed with type 2 diabetes at least 6 months. Received insulin and/or oral antidiabetic treatment, literate, and having no communication problems, between the ages of 18 and 65, whose arterial blood pressure is in range of systolic ≤ 160mmHg and diastolic ≤ 100mmHg, who had HbA1c between 7-9 % will be included in the study. The patients who agree to participate in the study (voluntarily) and who have no objection to exercising with cardiology consultation will be included in the study.
Exclusion Criteria:
Participants with diabetes-related (severe) complications and diabetic foot, pregnancy, diagnosed with cancer, having physical and mental problems that prevent walking will be excluded from the study. HA1C over 9 - despite the treatment (will be referred to the doctor for treatment change). Patients with blood sugar above 300 - despite treatment (will be referred to their doctor for a change in treatment).
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention Group
After the initial assessment, patients in this group will be educated by the researcher on walking exercise by using the transtheoritical model. The data will be collected from the patients in the experimental group at baseline, 1st, 3rd, and 6th months of the programme. The data will be collected by using Exercise Stages of Change Questionnaire, Exercise Processes of Change Scale, Pedometer, Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale, and patient identification that includes five domain. These domains include questions about the patients' sociodemographic characteristics, habits, knowledge of diabetes and its treatment, exercise status, and the evaluation of the metabolic control variables. |
This intervention will be applied to the patients in the experimental group.
The education will be provided by the researcher and based on the transtheoritical model.
Printed materials and PowerPoint presentations will be used for the education and the education will be conducted in a face-to-face session with each participant (10 weeks).
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无干预：Control
No intervention will be applied to this group. The data will be collected from the patients in the control group at baseline, 1st, 3rd, and 6th months. The data will be collected by using Exercise Stages of Change Questionnaire, Exercise Processes of Change Scale, Pedometer, Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale, and patient identification that includes five domain. These domains included questions about the patients' sociodemographic characteristics, habits, knowledge of diabetes and its treatment, exercise status, and the evaluation of the metabolic control variables. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Metabolic Parameters 1
大体时间：The change in 6 months from baseline
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Fasting Blood Glucose (mg/dL), the fasting blood glucose will be assessed by taking blood sample from the patients.sample
from the patients.
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The change in 6 months from baseline
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Metabolic Parameters 2
大体时间：The change in 6 months from baseline
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HbA1c (both % and mmol/mol), the HbA1c will be assessed by taking blood sample from the patients.
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The change in 6 months from baseline
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Metabolic Parameters 3
大体时间：The change in 6 months from baseline
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Total cholesterol (mg/dL), the total cholesterol will be assessed by taking blood sample from the patients.
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The change in 6 months from baseline
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Metabolic Parameters 4
大体时间：The change in 6 months from baseline
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Creatinine (mg/dL), the creatinine will be assessed by taking blood sample from the patients.
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The change in 6 months from baseline
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Exercise Stages of Change Questionnaire
大体时间：The change in 6 months from baseline
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Prochaska et al. (1992) studied how people change.
Marcus et al. developed a structured questionnaire to measure the stages of exercise changes.
Ay and Temel (2015) adapted the questionnaire to Turkish society.
The scale consists of five questions about the patient's stage of change (prethinking, thinking, preparation, taking action, and maintenance).
In the pre-thinking stage, the patients do not plan to start exercise now or during the next 6 months.
The patients in the thinking stage do not make an effort to exercise actively, but intend to start in the next 6 months.
The patients in the preparation stage intend to start exercising regularly in the next 30 days.
The patients in the taking action stage have started exercising within the last 6 months.
The patients in the maintenance stage continue to change over the course of the action, exercise more than 6 months and are confident and determined not to return to previous behavior.
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The change in 6 months from baseline
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Exercise Processes of Change Scale
大体时间：The change in 6 months from baseline
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The exercise processes of change scale was developed by Marcus et al. and adapted to Turkish society by Ay and Temel.
Exercise processes of change is based on a 5-point Likert type scale and consists of 28 items.
The maximum score that a patient can obtain on the scale is 140, the minimum score is 28.
The scale consists of 10 sub-dimensions and two main processes (behavioral and cognitive).
Behavioral processes are opposition, helping relationships, empowerment management, self-emancipation and stimulus control.
Cognitive processes are increased awareness, dramatic help, environmental reassessment, self reassessment, social independence.
The higher the scale score is indicates a higher success of the change.
In this study, the general Cronbach alpha reliability coefficient of the scale was determined as 0.96 (behavioral process = 0.94 and cognitive process = 0.93).
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The change in 6 months from baseline
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Patient Compliance in Type 2 Diabetes Mellitus Treatment Scale
大体时间：The change in 6 months from baseline
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This scale consists of 30 questions and a five-point Likert type rating is used.
There are 13 positive and 17 negative items in the scale.
Scoring ranges from 1 to 5 for positive items, and reverse scoring ranges from 5 to 1 for negative items.
The highest score obtained from the scale is 150, the lowest score is 30.
30-54 points from the scale indicates "good adherence to treatment", 55-125 points "medium adherence to treatment", and 126-150 points indicate that the patient's adherence to treatment is poor.
The scale was developed by Demirtaş and Albayrak for use in Turkish society.
Cronbach's alpha value was found to be 0.77.
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The change in 6 months from baseline
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Pedometer
大体时间：The change in 6 months from baseline
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A pedometer is a portable, small, inexpensive, and objective tool used to measure the number of steps.
The pedometer includes a mechanical motion sensitive sensor that detects movements during walking.
To prevent diseases and encourage healthy lifestyles, 150 minutes exercise and 10,000 steps per day are recommended.
The researcher will provide participants with Omron brand HJ-320-E model pedometers to record 7days of activity data.
These records were used to calculate the average number of steps per day.
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The change in 6 months from baseline
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合作者和调查者
调查人员
- 研究主任：Gulengul Mermer、Ege Uninersity
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
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首次发布 (实际的)
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最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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