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Physical Exercise for Prevention of Dementia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02236416
Acronym
EPD
Enrollment
1000
Registered
2014-09-10
Start date
2011-05-31
Completion date
2020-07-31
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Memory Disorders, Mild Cognitive Impairment

Keywords

Dementia, Prevention, Physical Activity

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.

Interventions

BEHAVIORALIntervention group

Supervised, multimodal physical activity including aerobic, resistance and stretching exercises

BEHAVIORALControl group

Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education

Sponsors

University of Molise
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Mini Mental State Examination (MMSE) score from baseline to 48 monthsBaseline and every 6-12 months, over an intervention period of 48 monthsScale for grading cognitive function

Secondary

MeasureTime frameDescription
Change of neuropsychological test battery from baseline to 48 monthsBaseline and every 6 -12 months, over an intervention period of 48 monthsIt 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.
Change of Geriatric Depression Scale (GDS) from baseline to 48 monthsBaseline and every 6 -12 months, over an intervention period of 48 monthsA self-report assessment for identifing depression in the elderly
Change of Short-form Health Survey (SF-36) from baseline to 48 monthsBaseline and every 6 -12 months, over an intervention period of 48 monthsAssessment of health status
Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 monthsBaseline and every 6 -12 months, over an intervention period of 48 monthsAssessment of physical activity level in elderly
Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 monthsBaseline and every 6 -12 months, over an intervention period of 48 monthsFunctional fitness assessment
Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 monthsBaseline and every 6 -12 months, over an intervention period of 48 monthsAssessment of subjective memory complaint

Other

MeasureTime frameDescription
Change of Composite cognitive score (CCS) from baseline to 48 monthsBaseline and every 6 -12 months, over an intervention period of 48 monthsIt is calculated by averaging the standardized scores (Z-score) of all neuropsychological tests, for assessing the overall changes in cognitive performance.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026