Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05580120
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2022-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Online-supervised Exercise Program in Elderly People With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'They did not know if they were in the control and intervention group at the time of randomization.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Brief Resilience Scale', 'timeFrame': '5 minute', 'description': "The scale was developed by Smith et al. to measure individuals' resilience levels and was adapted to Turkish by Doğan. It is a one-dimensional 6-item measurement tool. High scores obtained from the scale indicate that the individual's psychological resilience is good. Cronbach's alpha internal consistency coefficient of the scale is .83."}, {'measure': 'A Measure of Quality of Life in the Elderly', 'timeFrame': '5 minute', 'description': 'This scale was developed by Hyde et al. in 2003 to measure the quality of life of the elderly. It was adapted to Turkish society in 2014 by Türkoğlu and Adıbelli. An increase in the total score indicates an increase in the quality of life. The scale consists of two sub-dimensions, namely "perceived autonomy and satisfaction" and "perceived disability". Cronbach\'s alpha value of the original scale is .91.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychological resilience', 'quality of life', 'distance education'], 'conditions': ['Exercise Program', 'Type2diabetes']}, 'referencesModule': {'references': [{'pmid': '32759636', 'type': 'RESULT', 'citation': 'Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartin A, Sampedro-Nunez MA, Davalos A, Marazuela M. COVID-19 Lockdown and Changes of the Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. Nutrients. 2020 Aug 4;12(8):2327. doi: 10.3390/nu12082327.'}, {'pmid': '31014938', 'type': 'RESULT', 'citation': 'Duruturk N, Ozkoslu MA. Effect of tele-rehabilitation on glucose control, exercise capacity, physical fitness, muscle strength and psychosocial status in patients with type 2 diabetes: A double blind randomized controlled trial. Prim Care Diabetes. 2019 Dec;13(6):542-548. doi: 10.1016/j.pcd.2019.03.007. Epub 2019 Apr 20.'}, {'pmid': '33561280', 'type': 'RESULT', 'citation': 'Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.'}]}, 'descriptionModule': {'briefSummary': 'This study was conducted to determine the effect of an online-supervised exercise program on fasting blood sugar, psychological resilience, and quality of life in elderly people with diabetes. A parallel-group, randomized controlled trial design was used. The study was conducted in a public hospital with 70 patients with elderly type 2 diabetes between Nowember 2021 and May 2022. A Personal Information Form, The Brief Resilience Scale and A Measure of Quality of Life in the Elderly were used to collect data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a diagnosis of Type 2 diabetes mellitus for at least 6 months,\n* Being aged \\>50 years,\n* Receiving oral antidiabetic and/or insulin therapy,\n* Having a smartphone or a computer,\n* Volunteering to participate in the study,\n\nExclusion Criteria:\n\n* Individuals who had type 2 DM, but were illiterate\n* Had vision and hearing loss\n* Did not volunteer to participate in the study'}, 'identificationModule': {'nctId': 'NCT05580120', 'briefTitle': 'Online-supervised Exercise Program in Elderly People With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Mehmet Akif Ersoy University'}, 'officialTitle': 'The Effect of an Online-supervised Exercise Program in Elderly People With Diabetes on Fasting Blood Sugar, Psychological Resilience, and Quality of Life: A Double Blind Randomize Controlled Trial', 'orgStudyIdInfo': {'id': 'GO 2021/293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online-supervised exercise group', 'description': 'After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given online-supervised exercise education for 6 weeks.', 'interventionNames': ['Behavioral: Online-supervised exercise group']}, {'type': 'EXPERIMENTAL', 'label': 'The unsupervised-exercise training group', 'description': 'After the pre-tests (The Brief Resilience Scale, Quality of Life) , the patients were given unsupervised exercise education for 6 weeks.', 'interventionNames': ['Behavioral: Unsupervised-exercise training group']}], 'interventions': [{'name': 'Online-supervised exercise group', 'type': 'BEHAVIORAL', 'description': 'Participants in the online-supervised exercise group were provided with an online-supervised exercise program by using the video conferencing method three times a week for 6 weeks on the Zoom application. The exercise program was carried out synchronously', 'armGroupLabels': ['Online-supervised exercise group']}, {'name': 'Unsupervised-exercise training group', 'type': 'BEHAVIORAL', 'description': 'The unsupervised-exercise training group was informed about how to do the same exercises by another researcher, a nurse academician, on the online platform by using the lecturing method. Each training intervention took approximately 30 minutes.', 'armGroupLabels': ['The unsupervised-exercise training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15000', 'city': 'Burdur', 'country': 'Turkey (Türkiye)', 'facility': 'Burdur Mehmet Akif Ersoy University', 'geoPoint': {'lat': 37.72028, 'lon': 30.29083}}], 'overallOfficials': [{'name': 'Sabriye Ucan Yamac, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Burdur Mehmet Akif Ersoy University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All authors contributed to the interpretation, writing, and approval of the final manuscript.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mehmet Akif Ersoy University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Akdeniz University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nurten Terkes', 'investigatorAffiliation': 'Mehmet Akif Ersoy University'}}}}