Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 11:56 AM
Study NCT ID:
NCT03766802
Status:
UNKNOWN
Last Update Posted:
2019-02-01
First Post:
2018-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Wearable Technology and Smart Phone Applications Based Exercise Training in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Group 1: Wearable watch training group. 3 orientation session Watch notifies 3/week for exercise\n\nBenefits of watch:\n\nBP and movement sensors allow to validate if the patient has exercised. Videos for exercises. Trackable and notifiable if patients don't exercise. Group 2: Mobile application training group. 3 orientation session App notifies 3/week for exercise\n\nBenefits of app:\n\nCheaper Trackable and notifiable if patients don't exercise. Group 3: Supervised exercise training in a fitness center for people with DM."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2018-12-01', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exercise Adherence Rating Scale (EARS)', 'timeFrame': '5 minutes', 'description': 'The EARS enables the measurement of adherence to prescribed home exercise. This may facilitate the evaluation of interventions promoting self-management for both the prevention and treatment of chronic conditions.'}, {'measure': 'Behavioural Regulations in Exercise Questionnaire', 'timeFrame': '5 minutes', 'description': 'The Behavioural Regulation In Exercise Questionnaire (BREQ) and its subsequent modifications have become the most widely used measures of the continuum of behavioural regulation in exercise psychology research'}, {'measure': 'HDL / LDL', 'timeFrame': '5 minutes', 'description': 'The main goal is to lower LDL-cholesterol and increase HDL-cholesterol. Therefore, HDL and LDL were measured before and after the intervention to identify whether our program had an effect on the cholesterol level. The unit is mmol/L and it comes as a continuous variable.'}, {'measure': 'Triglyceride', 'timeFrame': '5 minutes', 'description': "Triglycerides are a type of fat (lipid) found in people' blood. It was also measured to estimate the extent to which our intervention had effect on the blood-fat level. The unit is mmol/L and it comes as a continuous variable."}], 'primaryOutcomes': [{'measure': 'Glycated Hemoglobin (HbA1c)', 'timeFrame': '5 minutes', 'description': 'It used as a diagnostic test for diabetes and as assessment test for glycemic control in people with diabetes. It comes in unit of percentage identifies how much glucose is carried on a certain amount of blood. We included people who have 6.5% or more which is the cut point for The International Diabetes Federation and the American College of Endocrinology.'}], 'secondaryOutcomes': [{'measure': 'Six-Minute Walk Test', 'timeFrame': '6 min', 'description': 'The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes'}, {'measure': 'The forced vital capacity', 'timeFrame': '10 minutes', 'description': 'The forced vital capacity (FVC) is a measurement of the maximum volume of gas a patient can exhale as forcefully and quickly as possible after a maximal inspiration.Pulmonary function test used to determine forced vital capacity. Breathing multiple times into a spirometry, with regular and maximal effort, through a tube that is connected to a computer. The unit for this test is in volume (L). And it will be analyzed as a continuous variable.'}, {'measure': 'Forced expiratory volume', 'timeFrame': '10 minutes', 'description': 'Forced expiratory volume (FEV) measures how much air a patient can exhale during a forced breath. Pulmonary function test used to determine Forced expiratory volume.The amount of air exhaled is measured during the first (FEV1), second (FEV2), and/or third seconds (FEV3) of the forced breath. The unit for this test is in volume (L). And it will be analyzed as a continuous variable.'}, {'measure': 'Assessment of muscle strength with isokinetic device', 'timeFrame': '15 minutes', 'description': "An assessment of muscle strength is typically performed as part of a patient's objective assessment."}, {'measure': 'International physical activity questionnaire short form (IPAQ)', 'timeFrame': '7 days', 'description': 'The International Physical Activity Questionnaire (IPAQ) is used as a comparable and standardised self-report measure of habitual physical activity.'}, {'measure': 'Accelerometer', 'timeFrame': '7 days', 'description': 'Accelerometer is a device that measures hours of physical activity in a week. The device was placed on the belt of the participants and was collected back after 7 days. Accelerometer collects data on the three-dimensional angles, which explains the direction, frequency, and magnitude of the movement. Total number of hours of physical activity is used to measure whether participants meet the optimal activity level recommended by physical activity guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2', 'Physical activity', 'exercise behavior', 'exercise', 'smart phone', 'wearable technology', 'self-management', 'glycated hemoglobin (HbA1c)'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.', 'detailedDescription': 'The purpose of this study is to estimate the extent to which supported exercise training through wearable technology and mobile application affects glycemic control in comparison to supervised exercise training in patients with Type-2 Diabetes.\n\nInclusion Criteria:\n\n* Age 18-65\n* No other chronic condition\n* No exercise training background Block Randomization according to age and sex.\n\nConfirmatory Outcome\n\n\\- Glycated Hemoglobin (HbA1c)\n\nExplanatory outcomes\n\n* Flexibility\n* Level of Physical Activity - IPaQ (METS) and accelerometer\n* Hamstring / Quad strength - isokinetic\n* Grip strength\n* Respiratory function test - F1, FVC, F25, F75, F100\n* 6MWT\n* Balance - static, dynamic, proprioception, sit-to-stand balance\n* Body Muscle Percentage - bioelectrical impedance analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18-65 No other chronic condition No exercise training background\n\nExclusion Criteria:\n\n* Exclusion criteria are a set of predefined condition that is used to identify subjects who will not be included or who will have to withdraw from a research study after being included.'}, 'identificationModule': {'nctId': 'NCT03766802', 'briefTitle': 'Effects of Wearable Technology and Smart Phone Applications Based Exercise Training in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Effects of Wearable Technology and Smart Mobile Phone Applications Based Exercise Training and Supervised Exercise Training in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '09.2017.604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Wearable watch training group.', 'description': "Aerobic exercises Strengthening exercises Stretching exercises Balance exercises Dose was increased as person is able to tolerate. Form:intervention is trackable and notifiable if patients don't exercise with smartwatch.\n\nFrequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.", 'interventionNames': ['Behavioral: Wearable watch training group.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mobile application training group.', 'description': "Aerobic exercises Strengthening exercises Stretching exercises\n\nBalance exercises Form:intervention is trackable and notifiable if patients don't exercise with smartphone Dose was increased as person is able to tolerate. Frequency:3/week Duration:12 weeks Dosage:Dose was increased as person is able to tolerate.", 'interventionNames': ['Behavioral: Mobile application training group.']}, {'type': 'SHAM_COMPARATOR', 'label': 'Supervised exercise training group', 'description': 'Aerobic exercises Strengthening exercises Stretching exercises supervised by a physical therapist', 'interventionNames': ['Behavioral: Supervised exercise training group']}], 'interventions': [{'name': 'Wearable watch training group.', 'type': 'BEHAVIORAL', 'description': '3 orientation session Watch notifies 3/week for exercise', 'armGroupLabels': ['Wearable watch training group.']}, {'name': 'Mobile application training group.', 'type': 'BEHAVIORAL', 'description': "3 orientation session App notifies 3/week for exercise\n\nBenefits of app:\n\nCheaper Trackable and notifiable if patients don't exercise.", 'armGroupLabels': ['Mobile application training group.']}, {'name': 'Supervised exercise training group', 'type': 'BEHAVIORAL', 'description': '3/week training supervised by a physical therapist', 'armGroupLabels': ['Supervised exercise training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1464185881', 'city': 'Istanbul', 'state': 'Maltepe', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Health Sciences', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Eren Timurtas, PT, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}