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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
NCT02236416 |
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Date of registration:
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03/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Physical Exercise for Prevention of Dementia
EPD |
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Scientific title:
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Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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1000 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02236416 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Alfonso Di Costanzo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Molise |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Age > 50 years old
Exclusion Criteria:
- Medical conditions that compromise survival or limit physical activity
- Geriatric Depression Scale-15 score of 6 or higher
- Alcohol intake > 4 units/day
- Mini- Mental State Examination < 24
- Clinical Dementia Rating score of 1 or more
Age minimum:
50 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Memory Disorders
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Mild Cognitive Impairment
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Aging
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Intervention(s)
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Behavioral: Intervention group
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Behavioral: Control group
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Primary Outcome(s)
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Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
[Time Frame: Baseline and every 6-12 months, over an intervention period of 48 months]
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Secondary Outcome(s)
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Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months
[Time Frame: Baseline and every 6 -12 months, over an intervention period of 48 months]
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Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months
[Time Frame: Baseline and every 6 -12 months, over an intervention period of 48 months]
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Change of neuropsychological test battery from baseline to 48 months
[Time Frame: Baseline and every 6 -12 months, over an intervention period of 48 months]
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Change of Geriatric Depression Scale (GDS) from baseline to 48 months
[Time Frame: Baseline and every 6 -12 months, over an intervention period of 48 months]
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Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months
[Time Frame: Baseline and every 6 -12 months, over an intervention period of 48 months]
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Change of Short-form Health Survey (SF-36) from baseline to 48 months
[Time Frame: Baseline and every 6 -12 months, over an intervention period of 48 months]
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Secondary ID(s)
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21933_III/11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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