Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Memory Disorders
- Sponsor
- University of Molise
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Alfonso Di Costanzo, MD
MD, Professor of Neurology
University of Molise
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Scale for grading cognitive function
Secondary Outcomes
- Change of neuropsychological test battery from baseline to 48 months(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(Baseline and every 6 -12 months, over an intervention period of 48 months)
- Change of Geriatric Depression Scale (GDS) from baseline to 48 months(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(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(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(Baseline and every 6 -12 months, over an intervention period of 48 months)