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The principal aim of this study is to verify whether a program of supervised, multimodal physical exercise improves cognitive function and/or reduces the rate of cognitive decline in older adults
Community-dwelling volunteers, recruited from social centers, were invited to an in-person assessment that included a medical history questionnaire and examination, anthropometric measurements, blood tests for cardiovascular risk, and several outcome measures. Participants meeting the inclusion criteria were divided in 3 groups (participants without subjective or objective cognitive impairment, with subjective memory complaints and with mild cognitive impairments) and randomly assigned (1:1) to an experimental group or a control group, using a list of random numbers generated by a statistical software. The list was kept in a sealed envelope and a researcher, not directly involved in the recruitment and in the evaluation of the participants, assigned the allocation numbers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Physical exercise |
|
| Control group | Other | Posture Education/Unchanged condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Behavioral | Supervised, multimodal physical activity including aerobic, resistance and stretching exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mini Mental State Examination (MMSE) score from baseline to 48 months | Scale for grading cognitive function | Baseline and every 6-12 months, over an intervention period of 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of neuropsychological test battery from baseline to 48 months | It includes: Frontal Assessment Battery, Rey's Auditory Verbal Learning Test, Prose Memory, Stroop Color Word Interference Test, Attentive Matrices, Raven's Progressive Matrices, Trial Making Test, designs copying with and without programming models. | Baseline and every 6 -12 months, over an intervention period of 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Composite cognitive score (CCS) from baseline to 48 months | It is calculated by averaging the standardized scores (Z-score) of all neuropsychological tests, for assessing the overall changes in cognitive performance. | Baseline and every 6 -12 months, over an intervention period of 48 months |
Inclusion Criteria:
Age > 50 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfonso Di Costanzo, MD | University of Molise | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research and Training in Medicine of Aging (CeRMA) | Campobasso | Molise | 86100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31142290 | Derived | Iuliano E, di Cagno A, Cristofano A, Angiolillo A, D'Aversa R, Ciccotelli S, Corbi G, Fiorilli G, Calcagno G, Di Costanzo A; EPD Study Group. Physical exercise for prevention of dementia (EPD) study: background, design and methods. BMC Public Health. 2019 May 29;19(1):659. doi: 10.1186/s12889-019-7027-3. |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Behavioral | Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education |
|
| Change of Geriatric Depression Scale (GDS) from baseline to 48 months | A self-report assessment for identifing depression in the elderly | Baseline and every 6 -12 months, over an intervention period of 48 months |
| Change of Short-form Health Survey (SF-36) from baseline to 48 months | Assessment of health status | Baseline and every 6 -12 months, over an intervention period of 48 months |
| Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months | Assessment of subjective memory complaint | Baseline and every 6 -12 months, over an intervention period of 48 months |
| Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months | Assessment of physical activity level in elderly | Baseline and every 6 -12 months, over an intervention period of 48 months |
| Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months | Functional fitness assessment | Baseline and every 6 -12 months, over an intervention period of 48 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D001519 | Behavior |
| D008722 | Methods |