Physical Exercise for Prevention of Dementia

NCT ID: NCT02236416

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2020-07-31

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.

Conditions

Memory Disorders; Mild Cognitive Impairment; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Physical exercise

Group Type: EXPERIMENTAL

Intervention group

Intervention Type: BEHAVIORAL

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

Control group

Posture Education/Unchanged condition

Group Type: OTHER

Control group

Intervention Type: BEHAVIORAL

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

Interventions

Intervention group

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

Intervention Type: BEHAVIORAL

Control group

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Molise

OTHER

Sponsor Role: lead

Responsible Party

Alfonso Di Costanzo, MD

MD, Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alfonso Di Costanzo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Molise

Locations

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

Campobasso, Molise, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31142290 (View on PubMed)

Other Identifiers

21933_III/11

Identifier Type: -

Identifier Source: org_study_id