The Effect of The Walking Exercise Training Given According to Transtheoretical Model, and Follow-Up on Improving Exercise Behavior and Metabolic Control in Type 2 Diabetic Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03517527|
Recruitment Status : Completed
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
OBJECTIVE This study aims to find out the effects of walking exercise training, which is given according to Transtheoretical Model (TTM), and follow-up on improving exercise behavior and metabolic control in type 2 diabetic patients.
RESEARCH DESIGN AND METHODS The study was conducted as a pre-test, post-test experimental model with 76 intervention (INT) groups and 76 control (CON) groups adult type 2 diabetic patients providing the criteria of the study and followed-up by the diabetes polyclinic of Adıyaman Education and Research Hospital. Patient introduction form (PIF), TTM scales and pedometer were used to collect the data. TTM based training was given to the intervention group according to the patients' change stages at hospital 10 weeks once per every 2 weeks. PIF, TTM scales were applied after the training. PIF, TTM scales were applied to the groups 9 months after the pre-test again.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of The Walking Exercise Training Given According to Transtheoretical Model, and Follow-Up on Improving Exercise Behavior and Metabolic Control in Type 2 Diabetic Patients|
|Actual Study Start Date :||October 25, 2015|
|Actual Primary Completion Date :||November 30, 2016|
|Actual Study Completion Date :||November 30, 2016|
|No Intervention: Control|
Other Name: THE WALKING EXERCISE TRAINING GIVEN ACCORDING TO TRANSTHEORETICAL MODEL
- Patient Presentation Form [ Time Frame: baseline collected ]The patient presentation form includes questions that question the sociodemographic characteristics and habits of patients, their knowledge of diabetes and its treatment, their exercise status
- questions that evaluate the metabolic control variables. [ Time Frame: Change from Baseline at 9 months ]FBS, SBS, total cholesterol, HbA1c, LDL, triglyceride, diastolic and systolic BP
- Stages of Change for Exercise Questionnaire [ Time Frame: Change from Baseline at 9 months ]It was developed by Prochaska and DiClemente, adapted by Marcus et al. to exercise. It was adapted to Turkish society by Ay and Temel in 2007. The scale consists of five questions and reveals the stage of change where the individual in (pre-thinking, thinking, preparation, taking action and maintenance).
- Exercise Processes of Change Scale [ Time Frame: Change from Baseline at 9 months ]It was developed by Marcus et al. and adapted to Turkish society by Ay and Temel. Exercise Processes of Change Scale is based on a 5-point Likert type and consists of 28 items. The maximum score that an individual can get on the scale is 140, the minimum score is 28. The scale consists of 10 sub-dimensions and 2 main processes (behavioral process and cognitive process) facilitating change involving these sub-dimensions. Cognitive processes are increased awareness, dramatic help, environmental reassessment, self-reassessment, social independence. Behavioral processes are opposition, helping relationships, empowerment management, self-emancipation and stimulus control. The higher scale scores indicate the higher chance of success of the change.
- Exercise Self-Efficacy Scale [ Time Frame: Change from Baseline at 9 months ]It was developed by Marcus et al. and adapted to Turkish society by Ay and Temel. The scale consists of six items, in the form of five-point Likert. The maximum score that can be taken from the scale is 30 and the minimum score is 6. In the general evaluation of the scale, according to the general average composed of item score averages, the self-efficacy of high-value-average subjects is high, and the self-efficacy of subjects below the average is considered to be low.
- Exercise Decisional Balance Scale [ Time Frame: Change from Baseline at 9 months ]It was developed by Marcus et al. and adapted to Turkish society by Ay and Temel. There are two sub-dimensions that assess subjective perception including perceived benefits of exercise practice and perceived harmfulness of exercise. The scale is based on 5 point Likert type and consists of 10 items. The overall score of the scale is formed by subtracting the total score of the perceived harmfulness from the total score of the perceived benefit of the exercise practice. The maximum score can be taken from the scale is 20 and the minimum score is -20. The negative result indicates that in the exercise decisional balance, the perceived harmfulness is dominant and the positive result indicates that the perceived benefit of exercise practice is dominant on the scale.