Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-25 @ 2:14 PM
Study NCT ID:
NCT05295966
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2022-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multisensory Physical Exercises in People With Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of Gait at preferred pace', 'timeFrame': 'baseline', 'description': 'Variables: Speed (m/s)'}, {'measure': 'Speed of Gait at preferred pace', 'timeFrame': 'at week 8', 'description': 'Variables: Speed (m/s)'}, {'measure': 'Cadence of Gait at preferred pace', 'timeFrame': 'baseline', 'description': 'Variables: cadence (steps/min)'}, {'measure': 'Cadence of Gait at preferred pace', 'timeFrame': 'at week 8', 'description': 'Variables: cadence (steps/min)'}, {'measure': 'Step Length of Gait at preferred pace', 'timeFrame': 'baseline', 'description': 'Variables: Step Length (m)'}, {'measure': 'Step Length of Gait at preferred pace', 'timeFrame': 'at week 8', 'description': 'Variables: Step Length (m)'}, {'measure': 'Speed during Dual task gait', 'timeFrame': 'baseline', 'description': 'Variables: Speed (m/s)'}, {'measure': 'Speed during Dual task gait', 'timeFrame': 'at week 8', 'description': 'Variables: Speed (m/s)'}, {'measure': 'Cadence during Dual task gait', 'timeFrame': 'Baseline', 'description': 'Variables: cadence (steps/min)'}, {'measure': 'Cadence during Dual task gait', 'timeFrame': 'at week 8', 'description': 'Variables: cadence (steps/min)'}, {'measure': 'Step Length during Dual task gait', 'timeFrame': 'Baseline', 'description': 'Variables: Step Length (m)'}, {'measure': 'Step Length during Dual task gait', 'timeFrame': 'at week 8', 'description': 'Variables: Step Length (m)'}, {'measure': 'Time up & go test', 'timeFrame': 'baseline', 'description': 'Variables: time (seconds)'}, {'measure': 'Time up & go test', 'timeFrame': 'at week 8', 'description': 'Variables: time (seconds)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'rehabilitation', 'sensory stimulation'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to evaluate the efficacy of a combined training program of physical exercise and multisensory stimulation (Physiocognitive Integration) in people with mild/moderate cognitive impairment.', 'detailedDescription': "Alzheimer's disease and other dementias are the main cause of cognitive impairment, with a prevalence of 0.4% worldwide and 1.23 in Europe. The WHO estimates that the growth of people with cognitive impairment to some degree will increase in the coming years, exceeding 75 million people in the world in 2030, and 135 million in 2050. The prevention of cognitive deterioration is mainly based on the implementation of non-pharmacological therapies. Multisensory stimulation is a non-pharmacological therapy that has benefits in patients with cognitive impairment, producing an improvement in cognitive function.\n\nPhysical exercise is associated with a lower risk of onset of cognitive impairment and less cognitive impairment as well as a slower progression in people with mild cognitive impairment and in mild-stage dementias. In addition to the cognitive sphere, the positive effect of physical exercise in preventing falls has been widely studied.\n\nThe main objective of the study is to evaluate the efficacy of a combined training program of physical exercise and multisensory stimulation (Physiocognitive Integration) in people with mild/moderate cognitive impairment. In order to do this, a experimental group will perform 20 sessions of multisensory training in addition to their current therapy and a second, control group, only their current therapy. Before and after the time need to complete the 20 sessions, all subjects were perform a battery of motor and cognitive tasks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks).\n\nIn the case of subjects who are part of the intervention group, the following will also be inclusion criteria:\n\n* Caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application.\n* Availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers.\n\nExclusion Criteria:\n\n* Insufficient physical condition for participation.\n* Sensory deficits that make participation difficult.\n* Unstable clinical situation.\n* Unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.).\n* Presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation."}, 'identificationModule': {'nctId': 'NCT05295966', 'briefTitle': 'Multisensory Physical Exercises in People With Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Rey Juan Carlos'}, 'officialTitle': 'Effects of Multisensory Physical Exercises in People With Moderate Cognitive Impairment or Mild Dementia', 'orgStudyIdInfo': {'id': 'V1058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Subjects in the intervention group will perform 20 sessions of multisensory training', 'interventionNames': ['Other: Cognitive therapy', 'Behavioral: Physiocognitive Integration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Subjects in the Control Group will not perform 20 sessions of multisensory training and they will keep doing the current therapy', 'interventionNames': ['Other: Cognitive therapy']}], 'interventions': [{'name': 'Cognitive therapy', 'type': 'OTHER', 'description': 'Cognitive therapy', 'armGroupLabels': ['Control Group', 'Intervention Group']}, {'name': 'Physiocognitive Integration', 'type': 'BEHAVIORAL', 'description': 'Physiocognitive Integration', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28942', 'city': 'Fuenlabrada', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Rey Juan Carlos', 'geoPoint': {'lat': 40.28419, 'lon': -3.79415}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Rey Juan Carlos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffessor', 'investigatorFullName': 'Miguel Fernández del Olmo', 'investigatorAffiliation': 'Universidad Rey Juan Carlos'}}}}