Clinical trial NCT02236416: Physical Exercise for Prevention of Dementia
Official title: Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Memory Disorders
Mild Cognitive Impairment
Aging
Keywords: Dementia
Prevention
Physical Activity
Lead sponsor: University of Molise
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
timeFrame: Baseline and every 6-12 months, over an intervention period of 48 months
Secondary outcomes:
measure: Change of neuropsychological test battery from baseline to 48 months
timeFrame: Baseline and every 6 -12 months, over an intervention period of 48 months
measure: Change of Geriatric Depression Scale (GDS) from baseline to 48 months
timeFrame: Baseline and every 6 -12 months, over an intervention period of 48 months
measure: Change of Short-form Health Survey (SF-36) from baseline to 48 months
timeFrame: Baseline and every 6 -12 months, over an intervention period of 48 months
measure: Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months
timeFrame: Baseline and every 6 -12 months, over an intervention period of 48 months
measure: Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months
timeFrame: Baseline and every 6 -12 months, over an intervention period of 48 months
measure: Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months
timeFrame: Baseline and every 6 -12 months, over an intervention period of 48 months
Other outcomes:
measure: Change of Composite cognitive score (CCS) from baseline to 48 months
timeFrame: Baseline and every 6 -12 months, over an intervention period of 48 months
Locations:
city: Campobasso
country: Italy
facility: Center for Research and Training in Medicine of Aging (CeRMA)
state: Molise
Study officials:
affiliation: University of Molise
name: Alfonso Di Costanzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.