Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT04759469
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Exercise on Cardiometabolic Risk Factors in Type II 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': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'six minute walking distance (in meters)', 'timeFrame': '12 weeks', 'description': 'represent aerobic capacity (distance walked in 6 min)'}, {'measure': 'Glycated Hemoglobin (HbA1C)', 'timeFrame': '12 weeks', 'description': 'Representing glucose control over 120 days'}, {'measure': 'Fasting blood glucose', 'timeFrame': '12 weeks', 'description': 'Representing glucose level after 9 hours fasting'}, {'measure': 'Exercise enjoyment and acceptability', 'timeFrame': '12 weeks', 'description': 'The Physical Activity Enjoyment Scale (PACES) score, out of 119. It is an 18-item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items were negatively worded and seven items were positively worded. After reverse scoring the 11negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment.'}], 'secondaryOutcomes': [{'measure': 'Adherence rates', 'timeFrame': '12 weeks', 'description': 'To what extent the patients will adhere to the exercise protocol'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type II diabetes', 'cardiometabolic risk', 'high-intensity interval training'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Background: Physical activity is known to modify some of the diabetes risk factors; however, solid evidence is still needed to precisely know the optimum form of training best fits the individual needs of type II diabetic (T2D) patients.', 'detailedDescription': 'Objectives: the purpose of this study was to compare between high intensity interval training (HIIT) and moderate-intensity interval training (MIIT) effect on functional capacity (as a cardiorespiratory parameter), and on glucose control and glycated hemoglobin (HbA1C) (as metabolic parameters) in T2D patients, and to test exercise acceptability within these patients. Methods: 60 participants had participated in this study. Their ages ranged from 45 to 65 years. They were randomized into two equal groups (30/group); group (A) did HIIT and group (B) did MIIT. Both groups received 12 weeks of training. Measurements for six minute walking distance (6MWD), fasting blood glucose (FBG), and HbA1C levels were done before and after the study. Physical activity enjoyment scale (PACES) were filled by the patients by the end of the study; testing exercise enjoyment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Controlled type 2 diabetic patients who were clinically stable for at least 3 months before entering the study,\n* Aged 45-65 years\n* Non-smokers\n* body mass index (BMI) ranged between 20 to 39.9 Kg/m2\n* Fasting blood glucose ranged from (126-160) mg/dl\n* Sedentary lifestyle who didn't engage in physical activity for more than half an hour/ day for at least one month before entering the study.\n\nExclusion Criteria:\n\n* unstable medical condition\n* smoker, recent surgery\n* Body mass index is more than 39.9 kg/m2 or less than 20 kg/m2\n* Any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise"}, 'identificationModule': {'nctId': 'NCT04759469', 'briefTitle': 'Effect of Exercise on Cardiometabolic Risk Factors in Type II Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Time-efficient Exercise Training on Cardiometabolic Risk Factors in Type II Diabetic Patients: A Randomized Mixed-methods Feasibility Study', 'orgStudyIdInfo': {'id': 'HIIT on DM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity interval training (HIIT)', 'description': 'A high-intensity interval training program for 3 days/week (day after day) for 12 weeks on atreadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program intensity.', 'interventionNames': ['Behavioral: High-intensity interval training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate intensity interval training (MIIT)', 'description': 'A moderate intensity interval training program for 3 days/week (alternate days) on a treadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program.', 'interventionNames': ['Behavioral: Moderate intensity interval training']}], 'interventions': [{'name': 'High-intensity interval training', 'type': 'BEHAVIORAL', 'description': 'High-intensity interval training is a form of intermittent training using relatively high exercise intensity', 'armGroupLabels': ['High-intensity interval training (HIIT)']}, {'name': 'Moderate intensity interval training', 'type': 'BEHAVIORAL', 'description': 'Moderate intensity interval training is a form of intermittent training using moderate exercise intensity', 'armGroupLabels': ['Moderate intensity interval training (MIIT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11847', 'city': 'Cairo', 'state': 'AI Qahirah', 'country': 'Egypt', 'facility': 'Alkasr Alaini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Hady Atef, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of physical therapy, Cairo University, Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after 1 month for12 months', 'ipdSharing': 'YES', 'description': 'After approval can be shared', 'accessCriteria': 'will upload it to the journal of publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy', 'investigatorFullName': 'Hady Atef Labib', 'investigatorAffiliation': 'Cairo University'}}}}