Physical Exercise for Prevention of Dementia

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Memory Disorders; Aging
• Interventions: Behavioral: Intervention group; Behavioral: Control group

• Registration Number: NCT02236416
• Lead Sponsor: University of Molise

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-10
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention group	Physical exercise
Control group	Control group	Posture Education/Unchanged condition

Primary Outcome Measures

Name	Time	Method
Change of Mini Mental State Examination (MMSE) score from baseline to 48 months	Baseline and every 6-12 months, over an intervention period of 48 months	Scale for grading cognitive function

Secondary Outcome Measures

Name	Time	Method
Change of Geriatric Depression Scale (GDS) from baseline to 48 months	Baseline and every 6 -12 months, over an intervention period of 48 months	A self-report assessment for identifing depression in the elderly
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	Assessment of health status
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	Assessment of physical activity level in elderly
Change of neuropsychological test battery from baseline to 48 months	Baseline and every 6 -12 months, over an intervention period of 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.
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	Assessment of subjective memory complaint
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	Functional fitness assessment

Trial Locations

Locations (1)

Center for Research and Training in Medicine of Aging (CeRMA); 🇮🇹 Campobasso, Molise, Italy