Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 2:01 AM
Study NCT ID:
NCT02774720
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2016-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Centre- Versus Home-based Exercise for MCI and Early Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)", 'timeFrame': 'baseline to 3 months', 'description': 'Change in continuous scores'}, {'measure': 'Change in cognitive function as characterized by the Stroop task', 'timeFrame': 'baseline to 3 months', 'description': 'Change in continuous scores'}, {'measure': 'Change in cognitive function as characterized by the Trail making task', 'timeFrame': 'baseline to 3 months', 'description': 'Change in continuous scores'}, {'measure': 'Change in cognitive function as characterized by the semantic fluency', 'timeFrame': 'baseline to 3 months', 'description': 'Change in continuous scores'}, {'measure': 'Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores', 'timeFrame': 'baseline to 3 months', 'description': 'Change in continuous scores'}, {'measure': 'Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D)', 'timeFrame': 'baseline to 3 months', 'description': 'Change in continuous scores'}, {'measure': 'Change in mood as measured with the Neuropsychiatric Inventory Questionnaire (NPI-Q) (depression/dysphoria, anxiety, apathy/indifference scales)', 'timeFrame': 'baseline to 3 months', 'description': 'Change in scores, number meeting screening criteria for depression'}, {'measure': 'Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6)', 'timeFrame': 'baseline to 3 months', 'description': 'Change in score'}, {'measure': 'Change in body mass index (BMI)', 'timeFrame': 'baseline to 3 months', 'description': 'Change in score'}, {'measure': 'Change in waist circumference', 'timeFrame': 'baseline to 3 months', 'description': 'Change in score'}, {'measure': 'Change in blood pressure', 'timeFrame': 'baseline to 3 months', 'description': 'Change in number with high blood pressure (\\>140 systolic blood pressure (SBP), \\>90 diastolic blood pressure (DBP))'}], 'primaryOutcomes': [{'measure': 'Achievement of Physical Activity', 'timeFrame': '3 months', 'description': 'Percent achievement of physical activity recommendations (150min/wk of moderate or high intensity physical activity) as objectively measured using an activity monitor.'}, {'measure': 'Change in physical activity', 'timeFrame': 'baseline to 3 months', 'description': 'Change in physical activity as objectively measured using an activity monitor.'}], 'secondaryOutcomes': [{'measure': 'Cost-effectiveness', 'timeFrame': '3 months', 'description': 'Cost of resource utilization per minute change in physical activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Dementia']}, 'referencesModule': {'references': [{'pmid': '29370756', 'type': 'DERIVED', 'citation': 'Middleton LE, Black SE, Herrmann N, Oh PI, Regan K, Lanctot KL. Centre- versus home-based exercise among people with mci and mild dementia: study protocol for a randomized parallel-group trial. BMC Geriatr. 2018 Jan 25;18(1):27. doi: 10.1186/s12877-017-0684-0.'}]}, 'descriptionModule': {'briefSummary': 'The study is a proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations. The primary outcome is achievement of physical activity recommendations. Secondary outcomes include cost-effectiveness and improvements in health and function.', 'detailedDescription': 'The aim of this trial is to compare the effectiveness of center-based versus home-based physical activity delivery among people with MCI and early dementia and to understand the influence of person and setting characteristics.\n\nOBJECTIVES:\n\nPrimary: To compare the effectiveness of centre-based versus home-based physical activity delivery among people with MCI or early dementia, as measured by percent achievement of physical activity guidelines.\n\nSecondary:\n\n(i) To determine the influence of person- and setting-specific factors. (ii) To estimate the cost-effectiveness of centre-based and home-based physical activity.\n\nExploratory:\n\ni) To compare the effect of centre- and home-based physical activity on other outcomes.\n\nii) To explore whether participants consider certain aspects of the program to be important to program effectiveness.\n\nMETHODS:\n\nThe investigators will conduct a 3-month proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations.\n\nParticipants will be randomized to one of two physical activity delivery options.The goal of both arms will be to have participants reach physical activity guidelines by the end of the 3-month intervention.\n\nParticipants who are randomized to centre-based physical activity will attend physical activity programming at a centre (University of Waterloo or Toronto Rehabilitation Institute) once per week for one hour. Additional physical activity will be prescribed at home.\n\nParticipants who are randomized to the home-based physical activity will received a physical activity prescription to be completed at home. They will also receive monthly support calls to assess achievements and barriers and to adjust the prescription.\n\nAll assessors will be blinded to group allocation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of MCI or mild dementia\n* Mini-Mental State Examination (MMSE)\\>=23 or Montreal Cognitive Assessment (MoCA)\\>=18\n* 50 years or older\n* Stable pharmaceutical regimen \\>=2 months\n* Be able to travel to centre\n* Have a care partner or significant other to support home-based exercise\n* Ability to walk \\>=2 minutes\n* Adequate English to understand exercise training\n* Adequate hearing and vision for cognitive tests\n* Able to comply with assessment and training schedule\n* Be screened safe for exercise by a physician or certified exercise physiologist\n\nExclusion Criteria:\n\n* Current moderate or high intensity exercise \\>=3 times per week\n* Unstable cardiovascular disease that precludes exercise\n* Musculoskeletal impairments that limit ability to walk\n* Pain or other co-morbidities that would limit exercise\n* Behavioural issues that would limit exercise training'}, 'identificationModule': {'nctId': 'NCT02774720', 'acronym': 'CHIME', 'briefTitle': 'Centre- Versus Home-based Exercise for MCI and Early Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'How do we Get People With MCI and Dementia to be Physically Active?', 'orgStudyIdInfo': {'id': '20687'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Centre-based physical activity', 'description': 'People with Mild Cognitive Impairment (MCI) and early dementia will receive centre-based physical activity for one hour each week for three months, plus at-home prescribed exercise.', 'interventionNames': ['Behavioral: Centre-based exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Home-based exercise', 'description': 'People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls.', 'interventionNames': ['Behavioral: Home-based exercise']}], 'interventions': [{'name': 'Centre-based exercise', 'type': 'BEHAVIORAL', 'description': 'Participants will come to a centre (University of Waterloo or Toronto Rehabilitation Institute) for a one-hour, small group exercise class each week. The classes will include progressive aerobic and resistance exercise. They will be prescribed additional exercise to be performed independently (either at home or in the community).', 'armGroupLabels': ['Centre-based physical activity']}, {'name': 'Home-based exercise', 'type': 'BEHAVIORAL', 'description': 'Participants will be prescribed aerobic and resistance exercise to be performed independently (either at home or in the community). They will receive monthly phone calls to discuss achievements and barriers and to tje adjust exercise prescription.', 'armGroupLabels': ['Home-based exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Research Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N2L3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Waterloo', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'collaborators': [{'name': "Alzheimer's Association", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}