Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT06886867
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Exergaming and Usual Care Physical Therapy in Nursing Home Residents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088544', 'term': 'Exergaming'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical function', 'timeFrame': 'Baseline, post-intervention (6 weeks) and 3 months follow-up.', 'description': 'Physical function will be assessed using the Short Physical Performance Battery (SPPB)'}], 'secondaryOutcomes': [{'measure': 'Hand grip strength', 'timeFrame': 'Baseline, post-intervention (6 weeks) and 3 months follow-up.', 'description': 'Hand grip strength will be assessed using a hand dynamometer.'}, {'measure': 'Exercise enjoyment', 'timeFrame': 'Post-intervention (6 weeks)', 'description': 'This outcome will be measured Physical Activity Enjoyment Scale (PACES). Higher values indicate higher perceived satisfaction/ enjoyment.'}, {'measure': 'Rate of Perceived Exertion', 'timeFrame': 'RPE will be measured inmediatley after the intervention', 'description': 'Rate of perceived exertion will be measured using Borg (RPE 1-10). Higher values indicate higher levels of perceived exertion'}, {'measure': 'Adherence', 'timeFrame': 'Through study completion (6 weeks), with a final adherence percentage calculated at the end of the intervention.', 'description': 'Adherence will be measured by the percentage of sessions attended of each participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Older Adults Institutionalized in Residential Homes']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to compare the effects of exergaming and usual care physical therapy on physical function in older adults residing in nursing homes.\n\nThis trial seeks to answer the following key questions:\n\n* Does physical function differ between interventions after treatment?\n* How do these interventions impact enjoyment of therapy?\n* Are there differences in adherence or perceived exertion between the interventions?', 'detailedDescription': 'A single-blind, randomized controlled trial will be conducted to compare exergaming and usual care interventions. Participants will be recruited from nursing homes in the province of Toledo, and the study will follow the CONSORT guidelines for clinical, crossover, and parallel trials.\n\nTwo experimental groups will be tested, with interventions performed three days per week for six weeks, each session lasting approximately 30 minutes. The exergaming group will play seven video games from the Party Fowl app, while the usual care group will continue their standard exercise routine.\n\nOutcome measures will be assessed at baseline, post-intervention (6 weeks), and at a 3-month follow-up to evaluate the middle-term effects of both interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects over 60 years of age\n* score equal to or greater than 20 on the Mini Mental cognitive test\n* Subjects that present the ability to stand without the use of technical aids or with the technical assistance of a device used for walking.\n\nExclusion Criteria:\n\n* severe visual impairment\n* medical contraindication for physical activity\n* pathology or problem that could prevent the test from being carried out.'}, 'identificationModule': {'nctId': 'NCT06886867', 'briefTitle': 'Comparing Exergaming and Usual Care Physical Therapy in Nursing Home Residents', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Physical Function in Older Adults: Exergaming vs. Usual Care in Physical Therapy - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HBA-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exergaming', 'description': 'This group will perform approximately 28 minutes of exergaming 3 times a week for 6 weeks', 'interventionNames': ['Other: Exergaming']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual physical therapy care', 'description': 'This group will perform their usual care exercises treatments for approximately 28 minutes for 3 times a week for 6 weeks', 'interventionNames': ['Other: Usual physical therapy care']}], 'interventions': [{'name': 'Exergaming', 'type': 'OTHER', 'description': 'Exergaming: Participants will perform different exercises through videogames', 'armGroupLabels': ['Exergaming']}, {'name': 'Usual physical therapy care', 'type': 'OTHER', 'description': 'Usual care: Different exercises will be performed', 'armGroupLabels': ['Usual physical therapy care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45510', 'city': 'Fuensalida', 'state': 'Toledo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diego Martin, MsC', 'role': 'CONTACT', 'email': 'residencianuevaesperanza@hotmail.com', 'phone': '925731257', 'phoneExt': '+34'}], 'facility': 'Nueva Esperanza Nursing Home', 'geoPoint': {'lat': 40.05288, 'lon': -4.20718}}, {'zip': '45071', 'city': 'Toledo', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Hector Beltran-Alacreu, PhD', 'role': 'CONTACT', 'email': 'hector.beltran@uclm.es', 'phone': '926051556'}], 'facility': 'Universidad de Castilla-La Mancha', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'centralContacts': [{'name': 'Hector Beltran-Alacreu, PhD', 'role': 'CONTACT', 'email': 'hector.beltran@uclm.es', 'phone': '926051556'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be provided to other researchers if asked to the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}