Mild Cognitive ImpairmentLLMNCT02267499
Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project
A study testing LLM training in people with Mild Cognitive Impairment and Mild Dementia, run by Aristotle University Of Thessaloniki.
Trial summary
The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended combined cognitive and physical exercise improves global cognition when compared to a control group; and that the number of… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia, Healthy
- What is being tested?
- LLM training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Apr 2013
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no severe cognitive impairment [Mini-Mental State Examination, MMSE ≥ 18], fluent language skills, agreement of a medical doctor and time commitment to the test and exercise protocol.
Who cannot join
- concurrent participation in another study, severe physical or psychological disorders which precluded participation in the intervention (i.e., inability to follow instructions), unrecovered neurological disorders such as stroke, traumatic brain injury, unstable medication within the past three months, severe and uncorrectable vision problems, or hearing aid for less than three months.
About this study
Official title: The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)
The study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended combined cognitive and physical exercise improves global cognition when compared to a control group; and that the number of sessions within exercising participants predict cognitive benefits. In addition, we explored the impact of potential moderators on combined exercise-induced cognitive benefits.
Read the detailed description
The multicenter study was part of the Long Lasting Memories (LLM) project (www.longlastingmemories.eu), which was funded by the European Commission (Information and Communication Technologies Policy Support Program (ICT-PSP) for a three year period (2009-2012). It used a pre-post-test design with the between-participant factor group [intervention vs. passive control]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Athens and Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, at university campus facilities (university community installations), and at participants' homes.
Institutions had to provide at least 5 exercise weeks, with a frequency of at least 1 physical and 2 cognitive exercise sessions per week, resulting in at least 5 physical and 10 cognitive exercise sessions in total.
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Healthy
- Being tested
- LLM training
- Keywords
- cognitive training, physical training, exercise games, novelty serious games, computer training, mild cognitive impairment, mild dementia, healthy elderly
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLM trainingOther
Also called PTC+CTC
Participants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
| Study group | Role | What they receive |
|---|---|---|
| LLM training | Experimental | Participants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC) Receives: Other: LLM training |
| Passive Control | No intervention | Participants do not receive an intervention serving as passive controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall cognition
Greek versions of the California Verbal Learning Test [CVLT], the Digit Span Test and the Trail Making Test [TMT] were used to assess cognitive outcomes.
Measured: 2 months
Secondary outcomes (8)
physical fitness
Physical capacity was measured by means of the Senior Fitness Test
Measured: 2 months
Episodic memory
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Measured: 2 months
working memory
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Measured: 2 months
executive function
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Measured: 2 months
Quality of Life
WHOQoL (WHO Quality of Life)
Measured: 2 months
Instrumental Activities of daily living
IADL
Measured: 2 months
Depressive symptoms
GDS (Geriatric depression scale)
Measured: 2 months
Brain function
changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Ulm, Greek Alzheimer's Association and Related Disorders
- Responsible party
- Principal investigator, Panos Bamidis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267499
- Sponsor's protocol ID
- 84171
- Other IDs
- 238904
- Acronym
- LLM
- Status last verified
- Oct 2014
- First submitted
- 14 Oct 2014
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)
- ClinicalTrials.gov ID
- NCT02267499
- Acronym / sponsor ID
- LLM / 84171
- Conditions
- Mild Cognitive Impairment, Mild Dementia, Healthy
- Keywords
- cognitive training, physical training, exercise games, novelty serious games, computer training, mild cognitive impairment, mild dementia, healthy elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, University of Ulm, Greek Alzheimer's Association and Related Disorders
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Oct 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 study involved Information and Communication Technologies (ICT) and more specifically computer exercises blended with game activities. It was hypothesized that ICT facilitated, game blended combined cognitive and physical exercise improves global cognition when compared to a control group; and that the number of sessions within exercising participants predict cognitive benefits. In addition, we explored the impact of potential moderators on combined exercise-induced cognitive benefits.
Detailed description
The multicenter study was part of the Long Lasting Memories (LLM) project (www.longlastingmemories.eu), which was funded by the European Commission (Information and Communication Technologies Policy Support Program (ICT-PSP) for a three year period (2009-2012). It used a pre-post-test design with the between-participant factor group [intervention vs. passive control]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Athens and Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, at university campus facilities (university community installations), and at participants' homes.
Institutions had to provide at least 5 exercise weeks, with a frequency of at least 1 physical and 2 cognitive exercise sessions per week, resulting in at least 5 physical and 10 cognitive exercise sessions in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLM training | Experimental | Other: LLM trainingParticipants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC) |
| Passive Control | No intervention | –Participants do not receive an intervention serving as passive controls |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- no severe cognitive impairment [Mini-Mental State Examination, MMSE ≥ 18], fluent language skills, agreement of a medical doctor and time commitment to the test and exercise protocol.
Key exclusion criteria (1 listed)
- concurrent participation in another study, severe physical or psychological disorders which precluded participation in the intervention (i.e., inability to follow instructions), unrecovered neurological disorders such as stroke, traumatic brain injury, unstable medication within the past three months, severe and uncorrectable vision problems, or hearing aid for less than three months.
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 |
|---|---|---|
| LLM trainingAlso: PTC+CTCParticipants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC) | Other | LLM training |
Primary outcome
overall cognition
Time frame: 2 months
Greek versions of the California Verbal Learning Test [CVLT], the Digit Span Test and the Trail Making Test [TMT] were used to assess cognitive outcomes.
8 secondary outcomes
physical fitness
Time frame: 2 months
Episodic memory
Time frame: 2 months
working memory
Time frame: 2 months
executive function
Time frame: 2 months
Quality of Life
Time frame: 2 months
Instrumental Activities of daily living
Time frame: 2 months
Depressive symptoms
Time frame: 2 months
Brain function
Time frame: 2 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 20 Oct 2014.
- The LLM project web siteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LLM training in people with Mild Cognitive Impairment and Mild Dementia, run by Aristotle University Of Thessaloniki.
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 1 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
overall cognition (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2014.