Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-01-28 @ 12:45 PM
Study NCT ID:
NCT03517527
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2018-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Presentation Form', 'timeFrame': 'baseline collected', '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'}, {'measure': 'questions that evaluate the metabolic control variables.', 'timeFrame': 'Change from Baseline at 9 months', 'description': 'FBS, SBS, total cholesterol, HbA1c, LDL, triglyceride, diastolic and systolic BP'}, {'measure': 'Stages of Change for Exercise Questionnaire', 'timeFrame': 'Change from Baseline at 9 months', '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).'}, {'measure': 'Exercise Processes of Change Scale', 'timeFrame': 'Change from Baseline at 9 months', '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.'}, {'measure': 'Exercise Self-Efficacy Scale', 'timeFrame': 'Change from Baseline at 9 months', '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.'}, {'measure': 'Exercise Decisional Balance Scale', 'timeFrame': 'Change from Baseline at 9 months', '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Metabolic Control', 'Walking Exercise', 'Transtheoretical Model', 'Nurse'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "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.\n\nRESEARCH 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT03517527', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Munzur University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MunzurU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['THE WALKING EXERCISE TRAINING GIVEN ACCORDING TO TRANSTHEORETICAL MODEL'], 'armGroupLabels': ['Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emine KAPLAN SERIN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Emine KAPLAN SERIN', 'investigatorAffiliation': 'Munzur University'}}}}