Mild Cognitive Impairment, So StatedLLM-AUTHNCT02313935
Cognitive/Physical Computer-Game Blended Training of Elderly: Neuroscientific LLM Studies
A study testing LLM, FFA and Brain Fitness in people with Mild Cognitive Impairment, So Stated 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 cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements… 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, So Stated, Mild Dementia, Healthy
- What is being tested?
- LLM, FFA and Brain Fitness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 581 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 [MMSE ≥ 18]
- fluent language skills
- agreement of a medical doctor
- 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: Effects of Cognitive and/or Physical Exercises Blended by Computer Games in Elderly: The LLM Project Neuroscientific Investigations in Thessaloniki, Greece by the LLM Team at the Aristotle University of Thessaloniki
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 cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.
Read the detailed description
The study was conducted in the Thessaloniki (Greece), in various centers. It 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(s) vs. passive and/or active control]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, and at participants' homes.
Centers had to provide 8 exercise weeks, with a frequency of at least 2 physical and 3 cognitive exercise sessions per week, resulting in at least 16 physical and 24 cognitive exercise sessions in total.
A similar trial was registered with Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02267499
- Conditions
- Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy
- Being tested
- LLM, FFA, Brain Fitness, VideoGrade
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLMOther
Also called PTC+CTC
LLM training 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)
FFAOther
PTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC)
Brain FitnessOther
CTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
VideoGradeOther
Active cognitive training by use of the VideoGrade software by AUTH.
| Study group | Role | What they receive |
|---|---|---|
| LLM | Experimental | LLM training 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 |
| PTC | Experimental | Physical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC). Receives: Other: FFA |
| CTC | Experimental | Cognitive training only. Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC) Receives: Other: Brain Fitness |
| Passive | No intervention | Passive Control Participants do not receive an intervention serving as passive controls |
| Active | Active comparator | Active Control Participants receive an alternative cognitive training scheme; software was built on purpose by the AUTH team. The software is called VideoGrade and uses YouTube documentaries. Receives: Other: VideoGrade |
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 Monhths
Secondary outcomes (8)
physical fitness
Physical capacity was measured by means of the Senior Fitness Test
Measured: 2 months / 6+2 months / 12+2 months
Episodic memory
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Measured: 2 months / 6+2 months / 12+2 months
working memory
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Measured: 2 months / 6+2 months / 12+2 months
executive function
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
Measured: 2 months / 6+2 months / 12+2 months
Quality of Life
WHOQoL
Measured: 2 months / 6+2 months / 12+2 months
Instrumental Activities of daily living
IADL
Measured: 2 months / 6+2 months / 12+2 months
Depressive symptoms
GDS
Measured: 2 months / 6+2 months / 12+2 months
Brain function
changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG and/or ERPs; changes in resting state networks; localisation of brain region activations/de-activations
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 posted10 Dec 2014 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment, So StatedStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Responsible party
- Principal investigator, Panos Bamidis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313935
- Sponsor's protocol ID
- 84171-A
- Acronym
- LLM-AUTH
- Status last verified
- Dec 2014
- First submitted
- 8 Dec 2014
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bamidis PD, Vivas AB, Styliadis C, Frantzidis C, Klados M, Schlee W, Siountas A, Papageorgiou SG. A review of physical and cognitive interventions in aging. Neurosci Biobehav Rev. 2014 Jul;44:206-20. doi: 10.1016/j.neubiorev.2014.03.019. Epub 2014 Apr 4.
PubMed 24705268Ladas A, Frantzidis C, Bamidis P, Vivas AB. Eye Blink Rate as a biological marker of Mild Cognitive Impairment. Int J Psychophysiol. 2014 Jul;93(1):12-6. doi: 10.1016/j.ijpsycho.2013.07.010. Epub 2013 Aug 1.
PubMed 23912068Frantzidis CA, Vivas AB, Tsolaki A, Klados MA, Tsolaki M, Bamidis PD. Functional disorganization of small-world brain networks in mild Alzheimer's Disease and amnestic Mild Cognitive Impairment: an EEG study using Relative Wavelet Entropy (RWE). Front Aging Neurosci. 2014 Aug 26;6:224. doi: 10.3389/fnagi.2014.00224. eCollection 2014.
PubMed 25206333Frantzidis CA, Ladas AK, Vivas AB, Tsolaki M, Bamidis PD. Cognitive and physical training for the elderly: evaluating outcome efficacy by means of neurophysiological synchronization. Int J Psychophysiol. 2014 Jul;93(1):1-11. doi: 10.1016/j.ijpsycho.2014.01.007. Epub 2014 Jan 25.
PubMed 24472698Klados MA, Styliadis C, Frantzidis CA, Paraskevopoulos E, Bamidis PD. Beta-Band Functional Connectivity is Reorganized in Mild Cognitive Impairment after Combined Computerized Physical and Cognitive Training. Front Neurosci. 2016 Feb 29;10:55. doi: 10.3389/fnins.2016.00055. eCollection 2016.
PubMed 26973445Styliadis C, Kartsidis P, Paraskevopoulos E, Ioannides AA, Bamidis PD. Neuroplastic effects of combined computerized physical and cognitive training in elderly individuals at risk for dementia: an eLORETA controlled study on resting states. Neural Plast. 2015;2015:172192. doi: 10.1155/2015/172192. Epub 2015 Apr 7.
PubMed 25945260
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive and/or Physical Exercises Blended by Computer Games in Elderly: The LLM Project Neuroscientific Investigations in Thessaloniki, Greece by the LLM Team at the Aristotle University of Thessaloniki
- ClinicalTrials.gov ID
- NCT02313935
- Acronym / sponsor ID
- LLM-AUTH / 84171-A
- Conditions
- Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Greek Alzheimer's Association and Related Disorders
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Dec 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 cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes; we explored the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.
Detailed description
The study was conducted in the Thessaloniki (Greece), in various centers. It 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(s) vs. passive and/or active control]. Post-test was conducted within 2 weeks after completion of the exercise period. Interventions were carried out in Thessaloniki (Greece) within day care centers, hospitals, senior care centers, a memory outpatient center, local parishes, and at participants' homes.
Centers had to provide 8 exercise weeks, with a frequency of at least 2 physical and 3 cognitive exercise sessions per week, resulting in at least 16 physical and 24 cognitive exercise sessions in total.
A similar trial was registered with Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02267499
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LLM | Experimental | Other: LLMLLM training 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) |
| PTC | Experimental | Other: FFAPhysical training only. Participants use the FitForAll exergaming computer platform as the physical training component (PTC). |
| CTC | Experimental | Other: Brain FitnessCognitive training only. Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC) |
| Passive | No intervention | –Passive Control Participants do not receive an intervention serving as passive controls |
| Active | Active comparator | Other: VideoGradeActive Control Participants receive an alternative cognitive training scheme; software was built on purpose by the AUTH team. The software is called VideoGrade and uses YouTube documentaries. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no severe cognitive impairment [MMSE ≥ 18]
- fluent language skills
- agreement of a medical doctor
- time commitment to the test and exercise protocol.
Key exclusion criteria (4 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 |
|---|---|---|
| LLMAlso: PTC+CTCLLM training 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) | Other | LLM |
| FFAPTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC) | Other | PTC |
| Brain FitnessCTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC) | Other | CTC |
| VideoGradeActive cognitive training by use of the VideoGrade software by AUTH. | Other | Active |
Primary outcome
overall cognition
Time frame: 2 Monhths
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 / 6+2 months / 12+2 months
Episodic memory
Time frame: 2 months / 6+2 months / 12+2 months
working memory
Time frame: 2 months / 6+2 months / 12+2 months
executive function
Time frame: 2 months / 6+2 months / 12+2 months
Quality of Life
Time frame: 2 months / 6+2 months / 12+2 months
Instrumental Activities of daily living
Time frame: 2 months / 6+2 months / 12+2 months
Depressive symptoms
Time frame: 2 months / 6+2 months / 12+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 11 Dec 2014.
- Background: PubMed 24705268Bamidis PD, Vivas AB, Styliadis C, Frantzidis C, Klados M, Schlee W, Siountas A, Papageorgiou SG. A review of physical and cognitive interventions in aging. Neurosci Biobehav Rev. 2014 Jul;44:206-20. doi: 10.1016/j.neubiorev.2014.03.019. Epub 2014 Apr 4.
- Background: PubMed 23912068Ladas A, Frantzidis C, Bamidis P, Vivas AB. Eye Blink Rate as a biological marker of Mild Cognitive Impairment. Int J Psychophysiol. 2014 Jul;93(1):12-6. doi: 10.1016/j.ijpsycho.2013.07.010. Epub 2013 Aug 1.
- Results publication: PubMed 25206333Frantzidis CA, Vivas AB, Tsolaki A, Klados MA, Tsolaki M, Bamidis PD. Functional disorganization of small-world brain networks in mild Alzheimer's Disease and amnestic Mild Cognitive Impairment: an EEG study using Relative Wavelet Entropy (RWE). Front Aging Neurosci. 2014 Aug 26;6:224. doi: 10.3389/fnagi.2014.00224. eCollection 2014.
- Results publication: PubMed 24472698Frantzidis CA, Ladas AK, Vivas AB, Tsolaki M, Bamidis PD. Cognitive and physical training for the elderly: evaluating outcome efficacy by means of neurophysiological synchronization. Int J Psychophysiol. 2014 Jul;93(1):1-11. doi: 10.1016/j.ijpsycho.2014.01.007. Epub 2014 Jan 25.
- Derived from this study: PubMed 26973445Klados MA, Styliadis C, Frantzidis CA, Paraskevopoulos E, Bamidis PD. Beta-Band Functional Connectivity is Reorganized in Mild Cognitive Impairment after Combined Computerized Physical and Cognitive Training. Front Neurosci. 2016 Feb 29;10:55. doi: 10.3389/fnins.2016.00055. eCollection 2016.
- Derived from this study: PubMed 25945260Styliadis C, Kartsidis P, Paraskevopoulos E, Ioannides AA, Bamidis PD. Neuroplastic effects of combined computerized physical and cognitive training in elderly individuals at risk for dementia: an eLORETA controlled study on resting states. Neural Plast. 2015;2015:172192. doi: 10.1155/2015/172192. Epub 2015 Apr 7.
- The LLM project web siteLink provided by the sponsor.
- The Greek LLM continuation project/business activityLink provided by the sponsor.
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, FFA and Brain Fitness in people with Mild Cognitive Impairment, So Stated 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 4 inclusion and 4 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 11 Dec 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 Monhths). 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 NCT02313935, which also lists 6 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 11 Dec 2014.