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Physical Exercise for Prevention of Dementia (EPD)

Primary Purpose

Memory Disorders, Mild Cognitive Impairment, Aging

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
University of Molise
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Memory Disorders focused on measuring Dementia, Prevention, Physical Activity

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Research and Training in Medicine of Aging (CeRMA)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

Physical exercise

Posture Education/Unchanged condition

Outcomes

Primary Outcome Measures

Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
Scale for grading cognitive function

Secondary Outcome Measures

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.
Change of Geriatric Depression Scale (GDS) from baseline to 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
Assessment of health status
Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months
Assessment of subjective memory complaint
Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months
Assessment 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 months
Functional fitness assessment

Full Information

First Posted
September 3, 2014
Last Updated
July 19, 2021
Sponsor
University of Molise
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1. Study Identification

Unique Protocol Identification Number
NCT02236416
Brief Title
Physical Exercise for Prevention of Dementia
Acronym
EPD
Official Title
Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Molise

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders, Mild Cognitive Impairment, Aging
Keywords
Dementia, Prevention, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Physical exercise
Arm Title
Control group
Arm Type
Other
Arm Description
Posture Education/Unchanged condition
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
Supervised, multimodal physical activity including aerobic, resistance and stretching exercises
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education
Primary Outcome Measure Information:
Title
Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
Description
Scale for grading cognitive function
Time Frame
Baseline and every 6-12 months, over an intervention period of 48 months
Secondary Outcome Measure Information:
Title
Change of neuropsychological test battery from baseline to 48 months
Description
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.
Time Frame
Baseline and every 6 -12 months, over an intervention period of 48 months
Title
Change of Geriatric Depression Scale (GDS) from baseline to 48 months
Description
A self-report assessment for identifing depression in the elderly
Time Frame
Baseline and every 6 -12 months, over an intervention period of 48 months
Title
Change of Short-form Health Survey (SF-36) from baseline to 48 months
Description
Assessment of health status
Time Frame
Baseline and every 6 -12 months, over an intervention period of 48 months
Title
Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months
Description
Assessment of subjective memory complaint
Time Frame
Baseline and every 6 -12 months, over an intervention period of 48 months
Title
Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months
Description
Assessment of physical activity level in elderly
Time Frame
Baseline and every 6 -12 months, over an intervention period of 48 months
Title
Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months
Description
Functional fitness assessment
Time Frame
Baseline and every 6 -12 months, over an intervention period of 48 months
Other Pre-specified Outcome Measures:
Title
Change of Composite cognitive score (CCS) from baseline to 48 months
Description
It is calculated by averaging the standardized scores (Z-score) of all neuropsychological tests, for assessing the overall changes in cognitive performance.
Time Frame
Baseline and every 6 -12 months, over an intervention period of 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Di Costanzo, MD
Organizational Affiliation
University of Molise
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Research and Training in Medicine of Aging (CeRMA)
City
Campobasso
State/Province
Molise
ZIP/Postal Code
86100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31142290
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.
Results Reference
derived

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Physical Exercise for Prevention of Dementia

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