NCT02236416

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

9.2 years

First QC Date

September 3, 2014

Last Update Submit

July 19, 2021

Conditions

Memory DisordersMild Cognitive ImpairmentAging

Keywords

DementiaPreventionPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Change of Mini Mental State Examination (MMSE) score from baseline to 48 months

    Scale for grading cognitive function

    Baseline and every 6-12 months, over an intervention period of 48 months

Secondary Outcomes (6)

  • Change of neuropsychological test battery from baseline to 48 months

    Baseline and every 6 -12 months, over an intervention period of 48 months

  • Change of Geriatric Depression Scale (GDS) from baseline to 48 months

    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

    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

    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

    Baseline and every 6 -12 months, over an intervention period of 48 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Change of Composite cognitive score (CCS) from baseline to 48 months

    Baseline and every 6 -12 months, over an intervention period of 48 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Physical exercise

Behavioral: Intervention group

Control group

OTHER

Posture Education/Unchanged condition

Behavioral: Control group

Interventions

Intervention groupBEHAVIORAL

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

Intervention group
Control groupBEHAVIORAL

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

Control group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 50 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Campobasso, Molise, 86100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31142290DERIVED

MeSH Terms

Conditions

Memory DisordersCognitive DysfunctionDementiaMotor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Alfonso Di Costanzo, MD

    University of Molise

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Neurology

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 10, 2014

Study Start

May 1, 2011

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 21, 2021

Record last verified: 2021-07

Locations

IT(1)