Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT03958318
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2019-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-component Exercise Program and Nutritional Supplementation in Frail Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2019-01-10', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed up and go test', 'timeFrame': '5-10 minutes', 'description': 'The participants will be instructed to stand up from a standard chair of 45 cm height, walk 3 metre, turn around a cone, return to the chair, and sit down again in the shortest time possible without running. Two trials will be performed, and the quicker time in seconds will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fragility']}, 'referencesModule': {'references': [{'pmid': '34417416', 'type': 'DERIVED', 'citation': 'Garcia-Gollarte F, Mora-Concepcion A, Pinazo-Hernandis S, Segura-Orti E, Amer-Cuenca JJ, Arguisuelas-Martinez MD, Lison JF, Benavent-Caballer V. Effectiveness of a Supervised Group-Based Otago Exercise Program on Functional Performance in Frail Institutionalized Older Adults: A Multicenter Randomized Controlled Trial. J Geriatr Phys Ther. 2023 Jan-Mar 01;46(1):15-25. doi: 10.1519/JPT.0000000000000326. Epub 2021 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance in frail institutionalized older adults.\n\nParticipants will be randomly allocated to the intervention groups; exercise (EG) or exercise plus nutritional supplementation (SG), or to the control group (CG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement.', 'detailedDescription': 'Objectives: Evaluate the effects of a multi-modal group-based exercise program and nutritional supplementation on physical performance and the capacity to perform daily tasks in frail institutionalized older adults.\n\nDesign: Randomized controlled trial, with a 6-month intervention period. Participants: 122 frail institutionalized older adults aged 65 and older with no cognitive impairment.\n\nIntervention: After a baseline assessment, the participants will be randomly assigned to the control group or one of two intervention groups; multi-modal exercise program (EG) or exercise plus nutritional supplementation (SG). During 6 months, participants in the intervention groups will be performing the exercise routine based on the Otago exercise programme. Additionally, participants in the SG will receive a daily oral nutritional supplement.\n\nMeasurements: The primary outcome measure will be mobility measured with the timed up and go test. Secondary outcomes will be the functional balance, hand-grip strength, lower limb functional capacity, gait speed and distance covered during the 6-minute walk test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years;\n* Frail institutionalized.\n\nExclusion Criteria:\n\n* Cognitive impairment;\n* Fracture;\n* Neurological disorder;\n* Unable to follow verbal instructions;\n* Score lower than 60 in the Barthel Index.'}, 'identificationModule': {'nctId': 'NCT03958318', 'briefTitle': 'Multi-component Exercise Program and Nutritional Supplementation in Frail Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'The Effectiveness of a Multi-component Exercise Program Plus Oral Nutritional Supplementation, on the Functional Capacity in Frail Institutionalized Older Adults.', 'orgStudyIdInfo': {'id': 'University CEU-UCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'Multi-modal exercise program', 'interventionNames': ['Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise plus nutritional suplementation', 'description': 'Multi-modal exercise program plus nutritional suplementation', 'interventionNames': ['Other: Exercise plus nutritional suplementation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No interventions'}], 'interventions': [{'name': 'Exercise plus nutritional suplementation', 'type': 'OTHER', 'description': 'For 6 months, all participants in the exercise plus nutritional supplementation group will be performing a three-week non-consecutive exercises programme at the facility. All exercises will be undertaken in a large indoor room. The exercise routine will be based on the Otago exercise programme.', 'armGroupLabels': ['Exercise plus nutritional suplementation']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'For 6 months, all participants in the exercise group will be performing a three-week non-consecutive exercises programme at the facility. All exercises will be undertaken in a large indoor room. The exercise routine will be based on the Otago exercise programme.', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46113', 'city': 'Alfara del Patriarca', 'country': 'Spain', 'facility': 'Vicent Benavent Caballer', 'geoPoint': {'lat': 39.55, 'lon': -0.38333}}], 'overallOfficials': [{'name': 'JUAN FRANCISCO L PÁRRAGA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardenal Herrera University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Medicine', 'investigatorFullName': 'Juan F. Lisón Párraga, Dr', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}