Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT06462534
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000073496', 'term': 'Frailty'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Functioning', 'timeFrame': '16 weeks', 'description': 'Physical functioning will be measured using the Short Physical Performance Battery (SPPB). The SPPB is a three-part standardized test including balance, gait, and chair stand components each scored out of 4 points for a total possible score ranging from 0 to 12 points. A higher SPPB score suggests high levels of physical functioning, while a lower SPPB score suggests functional limitations.'}], 'secondaryOutcomes': [{'measure': 'Frailty Status', 'timeFrame': '16 weeks', 'description': "Frailty status will be measured using Fried's Frailty Scale. The scale includes five frailty criteria: unintentional weight loss, exhaustion, low physical activity, slowness, and weak grip strength.\n\nParticipants will be scored in each of the five criteria and then given a cumulative score ranging from 0 to 5 to represent their frailty status. Participants who score three or more criteria will be considered frail, individuals who score one or two criteria will be considered pre-frail, and those who score zero criteria will be considered robust (non-frail)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elastic band resistance training', 'exercise intervention', 'aging', 'community intervention'], 'conditions': ['Type 2 Diabetes', 'Frailty']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test whether psychological, social, and physical health outcomes of older adults living with type 2 diabetes and frailty are improved when participating in the Band-Frail Program.', 'detailedDescription': 'Individuals considered fragile or frail and living with type 2 diabetes (T2D) have a 5-fold increased risk of being moved to a long-term care facility and a 4-fold increased risk of an emergency department visit. In 2013, the Mid-Frail study found that 16 weeks of combined exercise, diet, and education intervention significantly improved functional abilities in older adults living with T2D and frailty.\n\nThe goal of The Band-Frail Study is to implement an adapted version of the Mid-Frail program in New Brunswick (NB), while ensuring its sustainability by leveraging existing resources in the future as NB has one of the highest rates of diabetes in Canada and one of the highest average age of residents.\n\nThis project will include adults aged 65 years and above living with T2D and frailty across the province of New Brunswick (NB). Participants will meet in groups of 4-8 people twice a week for 16 weeks. One session will consist of diabetes management education delivered by a Certified Diabetes Educator and elastic band resistance training, while the second session will only involve the elastic band resistance training.\n\nParticipants will undergo pre- and post-testing including questionnaires, physical function tests, and interviews to assess the viability of this program in the province and determine the physical and psychological benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged over 65 years old\n* Classified as frail or pre-frail on Fried's Frailty Scale\n* Self-reported diagnosis of type 2 diabetes\n* Not physically active (3+ days of physical activity per week)\n\nExclusion Criteria:\n\n* Aged under 65 years old\n* Classified as robust of Fried's Frailty Scale\n* Not diagnosed with type 2 diabetes\n* Regularly physically active (3+ days of physical activity per week)"}, 'identificationModule': {'nctId': 'NCT06462534', 'briefTitle': 'The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick', 'organization': {'class': 'OTHER', 'fullName': 'University of New Brunswick'}, 'officialTitle': 'The Band-Frail Study: A Provincial Intervention to Outweigh Diabetes and Frailty in New Brunswick', 'orgStudyIdInfo': {'id': '2020-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Band-Frail Intervention', 'description': 'Individuals 65 years or older living with T2D and frailty will participate in elastic band resistance training and diabetes education sessions.', 'interventionNames': ['Behavioral: Band-Frail Program']}], 'interventions': [{'name': 'Band-Frail Program', 'type': 'BEHAVIORAL', 'description': 'Participants will complete 16 weeks of elastic band resistance training and diabetes management education.\n\nExercise Component:\n\nThe elastic band resistance training involves 12 exercises: chair sit-to-stands, seated chest press, seater upper back reverse fly, seated single arm row, seated single arm lateral raise, seated single arm bicep curl, seated single arm triceps extension, seated single leg quadriceps extension, standing hamstring curl, standing leg extension, and seated abdominal crunches.\n\nThere will be a one-minute rest between each set and a self-determined rest period between exercises.\n\nEducation Component:\n\nA certified Diabetes Educator and registered dietitian will present information to participants covering topics relating to T2D management and nutritional information.', 'armGroupLabels': ['Band-Frail Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E3B5A3', 'city': 'Fredericton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'University of New Brunswick- Faculty of Kinesiology', 'geoPoint': {'lat': 45.94541, 'lon': -66.66558}}], 'overallOfficials': [{'name': 'Martin Senechal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Brunswick'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Brunswick', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Agency of Canada (PHAC)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor, Martin Senechal, Ph.D.', 'investigatorFullName': 'Martin Senechal', 'investigatorAffiliation': 'University of New Brunswick'}}}}