Memory DisordersEPDNCT02236416
Physical Exercise for Prevention of Dementia
A study testing Intervention group in people with Memory Disorders and Mild Cognitive Impairment, run by University of Molise at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Disorders, Mild Cognitive Impairment, Aging
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 50 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Center for Research and Training in Medicine of Aging (CeRMA)
Campobasso, Molise, 86100
About this study
Official title: Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial
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
Read the 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
- Being tested
- Intervention group, Control group
- Keywords
- Dementia, Prevention, Physical Activity
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Supervised, multimodal physical activity including aerobic, resistance and stretching exercises
Control groupBehavioural
Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Physical exercise Receives: Behavioral: Intervention group |
| Control group | Other | Posture Education/Unchanged condition Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
Scale for grading cognitive function
Measured: 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
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.
Measured: Baseline and every 6 -12 months, over an intervention period of 48 months
Change of Geriatric Depression Scale (GDS) from baseline to 48 months
A self-report assessment for identifing depression in the elderly
Measured: 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
Assessment of health status
Measured: 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
Assessment of subjective memory complaint
Measured: 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
Assessment of physical activity level in elderly
Measured: Baseline and every 6 -12 months, over an intervention period of 48 months
Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months
Functional fitness assessment
Measured: Baseline and every 6 -12 months, over an intervention period of 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startMay 2011
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Memory DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Di Costanzo, MD, University of Molise
- Investigators
- Alfonso Di Costanzo, MD, Principal investigator, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236416
- Sponsor's protocol ID
- 21933_III/11
- Acronym
- EPD
- Status last verified
- Jul 2021
- First submitted
- 3 Sep 2014
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Iuliano E, Fiorilli G, Angiolillo A, Corbi G, Di Martino G, Ciccotelli S, Valle CD, Calcagno G, di Cagno A, Di Costanzo A. Physical exercise for prevention of dementia study: a 48-month randomized controlled trial. Front Aging. 2026 Aug 10;7:1847451. doi: 10.3389/fragi.2026.1847451. eCollection 2026.
PubMed 42639433Iuliano 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.
PubMed 31142290
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02236416
- Acronym / sponsor ID
- EPD / 21933_III/11
- Conditions
- Memory Disorders, Mild Cognitive Impairment, Aging
- Keywords
- Dementia, Prevention, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupPhysical exercise |
| Control group | Other | Behavioral: Control groupPosture Education/Unchanged condition |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 50 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupSupervised, multimodal physical activity including aerobic, resistance and stretching exercises | Behavioural | Intervention group |
| Control groupUsual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education | Behavioural | Control group |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 42639433Iuliano E, Fiorilli G, Angiolillo A, Corbi G, Di Martino G, Ciccotelli S, Valle CD, Calcagno G, di Cagno A, Di Costanzo A. Physical exercise for prevention of dementia study: a 48-month randomized controlled trial. Front Aging. 2026 Aug 10;7:1847451. doi: 10.3389/fragi.2026.1847451. eCollection 2026.
- Derived from this study: PubMed 31142290Iuliano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfonso Di Costanzo, MD principal investigator
University of Molise
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Memory Disorders and Mild Cognitive Impairment, run by University of Molise at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236416, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.