Physical Exercise for Prevention of Dementia (EPD)

July 19, 2021 updated by: Alfonso Di Costanzo, MD, University of Molise

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Molise
      • Campobasso, Molise, Italy, 86100
        • Center for Research and Training in Medicine of Aging (CeRMA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Physical exercise
Behavioral: Intervention group
Supervised, multimodal physical activity including aerobic, resistance and stretching exercises
Other: Control group
Posture Education/Unchanged condition
Behavioral: Control group
Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and every 6-12 months, over an intervention period of 48 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Composite cognitive score (CCS) from baseline to 48 months
Time Frame: Baseline and every 6 -12 months, over an intervention period of 48 months
It is calculated by averaging the standardized scores (Z-score) of all neuropsychological tests, for assessing the overall changes in cognitive performance.
Baseline and every 6 -12 months, over an intervention period of 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Molise

Investigators

  • Principal Investigator: Alfonso Di Costanzo, MD, University of Molise

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

September 3, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21933_III/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Intervention group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe