Physical Exercise for Prevention of Dementia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial

Conditions
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Memory Disorders, Mild Cognitive Impairment, Aging

Intervention / Treatment
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* Behavioral: Intervention group
* Behavioral: Control group


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Physical exercise | Behavioral: Intervention group<br>* Supervised, multimodal physical activity including aerobic, resistance and stretching exercises<br>|
| Other: Control group<br>Posture Education/Unchanged condition | Behavioral: Control group<br>* Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Prevention, Physical Activity