Physical Exercise for Prevention of Dementia

Aging Clinical Trial

— EPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236416
• Other study ID #: 21933_III/11
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: July 2020

Study information

• Verified date: July 2021
• Source: University of Molise
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Cognitive Dysfunction
• Dementia
• Memory Disorders
• Mild Cognitive Impairment

Intervention

Behavioral:
• Intervention group
Supervised, multimodal physical activity including aerobic, resistance and stretching exercises
• Control group
Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education

Locations

Country	Name	City	State
Italy	Center for Research and Training in Medicine of Aging (CeRMA)	Campobasso	Molise

Sponsors (1)

Lead Sponsor	Collaborator
University of Molise

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Composite cognitive score (CCS) from baseline to 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
Primary	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	Change of neuropsychological test battery from baseline to 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
Secondary	Change of Geriatric Depression Scale (GDS) from baseline to 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
Secondary	Change of Short-form Health Survey (SF-36) from baseline to 48 months	Assessment of health status	Baseline and every 6 -12 months, over an intervention period of 48 months
Secondary	Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months	Assessment of subjective memory complaint	Baseline and every 6 -12 months, over an intervention period of 48 months
Secondary	Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months	Assessment of physical activity level in elderly	Baseline and every 6 -12 months, over an intervention period of 48 months
Secondary	Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months	Functional fitness assessment	Baseline and every 6 -12 months, over an intervention period of 48 months