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
調査の概要
詳細な説明
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Gulengul Mermer, Ph.D
- 電話番号：+902323115536
- メール：gulengulmermer@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Metabolic Parameters 1
時間枠：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
時間枠：The change in 6 months from baseline
|
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
時間枠：The change in 6 months from baseline
|
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
時間枠：The change in 6 months from baseline
|
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
時間枠：The change in 6 months from baseline
|
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
時間枠：The change in 6 months from baseline
|
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
時間枠：The change in 6 months from baseline
|
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
時間枠：The change in 6 months from baseline
|
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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Gulengul Mermer、Ege Uninersity
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Type2DiabetesEge
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個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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