- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02267499
Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project (LLM)
The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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)
|
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 Names:
|
|
No Intervention: Passive Control
Participants do not receive an intervention serving as passive controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical fitness
Time Frame: 2 months
|
Physical capacity was measured by means of the Senior Fitness Test
|
2 months
|
|
Episodic memory
Time Frame: 2 months
|
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
|
2 months
|
|
working memory
Time Frame: 2 months
|
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
|
2 months
|
|
executive function
Time Frame: 2 months
|
calculated by averaging z-standardized sub-scores of the three cognitive tests (primary outcome)
|
2 months
|
|
Quality of Life
Time Frame: 2 months
|
WHOQoL (WHO Quality of Life)
|
2 months
|
|
Instrumental Activities of daily living
Time Frame: 2 months
|
IADL
|
2 months
|
|
Depressive symptoms
Time Frame: 2 months
|
GDS (Geriatric depression scale)
|
2 months
|
|
Brain function
Time Frame: 2 months
|
changes in abnormal brain waves that correlate with mild cognitive decline and dementia as measured by EEG
|
2 months
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 84171
- 238904 (Other Grant/Funding Number: European Commission Programme CIP-ICTPSP.2008.1.4)
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