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Physical Exercise for Prevention of Dementia (EPD)

U

University of Molise

Status

Completed

Conditions

Aging
Memory Disorders
Mild Cognitive Impairment

Treatments

Behavioral: Control group
Behavioral: Intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT02236416
21933_III/11

Details and patient eligibility

About

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

Full 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.

Enrollment

1,000 patients

Sex

All

Ages

50 to 90 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,000 participants in 2 patient groups

Intervention group
Experimental group
Description:
Physical exercise
Treatment:
Behavioral: Intervention group
Control group
Other group
Description:
Posture Education/Unchanged condition
Treatment:
Behavioral: Control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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