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Completed

NCT Number: NCT02236416

Physical Exercise for Prevention of Dementia

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

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Key information

Conditions

Memory Disorders Aging Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Campobasso, Molise, 86100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

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

Control Group

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Molise

Other

Registry information

Official study title

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

Acronym: EPD

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2014
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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