Healthy Clinical Trial
— LLMOfficial title:
The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)
Verified date | October 2014 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 322 |
Est. completion date | April 2013 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 55 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: 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. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki | Greek Association of Alzheimer's Disease and Related Disorders, National and Kapodistrian University of Athens, University of Ulm |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 months | No |
Secondary | physical fitness | Physical capacity was measured by means of the Senior Fitness Test | 2 months | No |
Secondary | Episodic memory | calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome) | 2 months | No |
Secondary | working memory | calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome) | 2 months | No |
Secondary | executive function | calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome) | 2 months | No |
Secondary | Quality of Life | WHOQoL (WHO Quality of Life) | 2 months | No |
Secondary | Instrumental Activities of daily living | IADL | 2 months | No |
Secondary | Depressive symptoms | GDS (Geriatric depression scale) | 2 months | No |
Secondary | Brain function | changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG | 2 months | No |
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