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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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Emine KAPLAN SERIN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Metabolic Control, Walking Exercise, Transtheoretical Model, Nurse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who were diagnosed with type-2 diabetes at least six months before, received basic diabetes information, received insulin and/or oral antidiabetic treatment, whose arterial blood pressure was in systolic ≤ 160 mmHg and diastolic ≤ 100 mmHg, who had HbA1c 7% and over, who were literate and had no communication problems were included in the study.

Exclusion Criteria:

  • Those who had developed diabetes-related complications (advanced), were pregnant, diagnosed with cancer, had physical and mental problems that prevent walking were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    Patient Presentation Form
    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.
    FBS, SBS, total cholesterol, HbA1c, LDL, triglyceride, diastolic and systolic BP
    Stages of Change for Exercise Questionnaire
    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
    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
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2018
    Last Updated
    April 24, 2018
    Sponsor
    Emine KAPLAN SERIN
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03517527
    Brief 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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 25, 2015 (Actual)
    Primary Completion Date
    November 30, 2016 (Actual)
    Study Completion Date
    November 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Emine KAPLAN SERIN

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Type 2 Diabetes Mellitus, Metabolic Control, Walking Exercise, Transtheoretical Model, Nurse

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    152 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Title
    Intervention
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Other Intervention Name(s)
    THE WALKING EXERCISE TRAINING GIVEN ACCORDING TO TRANSTHEORETICAL MODEL
    Primary Outcome Measure Information:
    Title
    Patient Presentation Form
    Description
    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
    Time Frame
    baseline collected
    Title
    questions that evaluate the metabolic control variables.
    Description
    FBS, SBS, total cholesterol, HbA1c, LDL, triglyceride, diastolic and systolic BP
    Time Frame
    Change from Baseline at 9 months
    Title
    Stages of Change for Exercise Questionnaire
    Description
    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).
    Time Frame
    Change from Baseline at 9 months
    Title
    Exercise Processes of Change Scale
    Description
    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.
    Time Frame
    Change from Baseline at 9 months
    Title
    Exercise Self-Efficacy Scale
    Description
    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.
    Time Frame
    Change from Baseline at 9 months
    Title
    Exercise Decisional Balance Scale
    Description
    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.
    Time Frame
    Change from Baseline at 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who were diagnosed with type-2 diabetes at least six months before, received basic diabetes information, received insulin and/or oral antidiabetic treatment, whose arterial blood pressure was in systolic ≤ 160 mmHg and diastolic ≤ 100 mmHg, who had HbA1c 7% and over, who were literate and had no communication problems were included in the study. Exclusion Criteria: Those who had developed diabetes-related complications (advanced), were pregnant, diagnosed with cancer, had physical and mental problems that prevent walking were excluded from the study.

    12. IPD Sharing Statement

    Learn more about this trial

    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

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