Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 4:33 PM
Study NCT ID:
NCT05711602
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2023-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Physical and Mental Health of People With Type II Diabetes Mellitus.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assignment to the groups will be of simple random type and hidden. Those responsible for admitting patients to the intervention phase will not know what group has been assigned each. This assignment will be made in advance by a researcher who will not intervene in the later stages of evaluation, intervention, data recording and elaboration of database. The assignment will be communicated through sealed and totally opaque envelopes.\n\nAll measurements given above will be made both to the control group and to the experimental group just prior to the start of the intervention, and immediately after and six months after the end of this period, and the results will be recorded in a data record'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-16', 'studyFirstSubmitDate': '2023-01-21', 'studyFirstSubmitQcDate': '2023-01-31', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamometer', 'timeFrame': 'Up to twelve weeks', 'description': 'Dynamometer will be employed to assess hand grip stregth.'}, {'measure': 'Blood Glucose Concentration', 'timeFrame': 'Up to twelve weeks', 'description': 'Capillary blood glucose monitoring is the primary tool for monitoring blood glucose levels at any time of day. It involves a small fingertip prick to check blood sugar levels at a specific time of day. This procedure requires a pen containing a fine needle or lancet, test strips, and a glucose meter (glucometer). Reference values vary depending on the time of sample collection: preprandial 80-130 mg/dL and postprandial \\<180 mg/dL. In Spain, this measurement is performed among older adults with type 2 diabetes mellitus.'}, {'measure': 'BMI (Body Mass Index)', 'timeFrame': 'Up to twelve weeks', 'description': 'Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.'}, {'measure': 'TUG (Timed Up and Go test)', 'timeFrame': 'Up to twelve weeks', 'description': "Is a simple test used to assess a person's mobility and physical function"}, {'measure': 'Chair sit and reach test', 'timeFrame': 'Up to twelve weeks', 'description': 'To test low back and hamstring flexibility.'}, {'measure': 'Back scratch test', 'timeFrame': 'Up to twelve weeks', 'description': 'To measure general shoulder range of motion.'}, {'measure': 'Height', 'timeFrame': 'Up to twelve weeks', 'description': 'The distance between the lowest and highest points of a person standing upright.'}, {'measure': 'BBS (the Berg Balance Scale)', 'timeFrame': 'Up to twelve weeks', 'description': 'Used to measure balance'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult ALL', 'Diabete Type 2']}, 'descriptionModule': {'briefSummary': 'To analyze the effects of a Pilates exercise program on physical and mental health in people with type II diabetes mellitus.', 'detailedDescription': 'This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.\n\nThe study will define two groups:\n\n* A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.\n* An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.\n\nOnce the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Not participating in an exercise program\n* That they were able to carry out the different selected questionnaires.\n\nExclusion Criteria:\n\n* Contraindications for performing physical tests\n* Illnesses that limit static and dynamic balance and physical activity\n* Central or peripheral vestibular or nervous disorders.'}, 'identificationModule': {'nctId': 'NCT05711602', 'briefTitle': 'The Physical and Mental Health of People With Type II Diabetes Mellitus.', 'organization': {'class': 'OTHER', 'fullName': 'University of Jaén'}, 'officialTitle': 'Influence of the Pilates Method on the Physical and Mental Health of People With Type II Diabetes Mellitus.', 'orgStudyIdInfo': {'id': 'University_of_Jaén'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates group', 'description': 'This group receives physical training based on pilates exercises', 'interventionNames': ['Other: Pilates']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention group', 'description': 'This group does not receive any treatment'}], 'interventions': [{'name': 'Pilates', 'type': 'OTHER', 'description': 'raining based on a basic level Pilates exercise program will be as follows: A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty.', 'armGroupLabels': ['Pilates group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23004', 'city': 'Jaén', 'country': 'Spain', 'facility': 'U.E.D. Virgen de la Capilla', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jaén', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapy', 'investigatorFullName': 'Agustín Aibar Almazán', 'investigatorAffiliation': 'University of Jaén'}}}}