Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05862935
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2023-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'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': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The persons analyzing the data collected (investigators, statician) will not know to which group each person belongs.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Physical Performance Battery', 'timeFrame': '0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining', 'description': 'Changes in the SPPB Score (Short Physical Performance Battery; Range between 0 "worst performance" and 12 "best performance")'}], 'secondaryOutcomes': [{'measure': 'Handgrip strength', 'timeFrame': '0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining', 'description': 'Changes in the hang-up strength in the dominant side'}, {'measure': 'Body mass index', 'timeFrame': '0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining', 'description': 'Changes in the body mass index'}, {'measure': 'Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.', 'timeFrame': 'Every session (during 13 sessions)', 'description': 'This variable evaluates the applicability of this tipe of training in patients with Alzheimer disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', 'Physical exercise', 'Locomotion'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The goal of this non-randomized clinical trial is to assess the effects of strength training in the physical function of Alzheimer's disease (AD) patients. The main question it aims to answer are:\n\n1. Is a basic strength training enough to improve physical function in AD patients?\n2. Is an exercise intervention able to delayed the progression of the disease?\n3. Is an AMRAP intervention feasible in AD patients?\n\nParticipants in the exercise group will perform a 16-weeks program divided in two phases (phase 1: basic strength training; phase 2: AMRAP training). Participants in both (exercise and control) groups will receive their usual care treatments which include occupational therapy, musicotherapy, cognitive stimulation and sensory stimulation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MMSE (Mini-Metal State Examination) score of ≥15 out of 35 (at screening less than 2 months prior to baseline visit)\n* Age ≥60 years old\n* Be able to walk with or without aids\n* Be able to follow verbal instructions\n\nExclusion Criteria:\n\n* Surgery in the last 3 months\n* Exhibit clear signs of disorientation\n* Clinically confirmed signs of aggressiveness'}, 'identificationModule': {'nctId': 'NCT05862935', 'briefTitle': "Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'European University Miguel de Cervantes'}, 'officialTitle': "Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'PI-DOC002-ALP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)', 'description': 'These patients, in addition to receiving the usual treatment for their pathology, carry out supervised activity consisting of:\n\n* Warm-up\n* Strength circuit; At phase I it will be a standard strength training, while at Phase 2 it will be an AMRAP training)', 'interventionNames': ['Other: Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2', 'Other: Supervised Physical Activity: Phase 1']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'These patients only receive the usual treatment for their pathology.'}], 'interventions': [{'name': 'Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2', 'type': 'OTHER', 'otherNames': ['AMRAP intervention'], 'description': '20-30 min/session, 3 times/week for 4 weeks. After a 5-min warm-up, participants perform a moderate-intensity functional training program. This program is designed in circuit mode consisting of 6 global functional exercises: i) sit and stand, ii) forward lunges, iii) chest press, iv) high row, v) lateral shoulder raises and vi) heel raises. Participants must complete the highest number of repetitions and/or rounds as possible (AMRAP) in 15-min without a designated rest.', 'armGroupLabels': ['Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)']}, {'name': 'Supervised Physical Activity: Phase 1', 'type': 'OTHER', 'otherNames': ['Basic strength intervention'], 'description': '40-60 min/session, 3 times/week for 12 weeks. After a 5-min warm-up, participants performed 6 global functional exercises: i) sit-to-stand; ii) chest press, iii) forward lunges; iv) unilateral shoulder raises; v) unilateral row; and vi) heel raises. The initial volume is 2 sets and 8 repetitions and it will progressively increase until 3 sets and 12 repetitions.', 'armGroupLabels': ['Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47012', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Universidad Europea Miguel de Cervantes', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European University Miguel de Cervantes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asociación de Familiares de Alzheimer de Valladolid', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}