Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The LLM Project

Healthy Clinical Trial

— LLM  

Official title:

The Effects of Combined Cognitive and Physical Exercises Through Computer Games in Elderly: The Long Lasting Memories Project (LLM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267499
• Other study ID #: 84171
• Secondary ID: 238904
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: October 17, 2014
• Start date: November 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical 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 sessions within exercising participants predict cognitive benefits. In addition, we explored the impact of potential moderators on combined exercise-induced cognitive benefits.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Healthy
• Mild Cognitive Impairment
• Mild Dementia

Intervention

Other:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

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

External Links

•   The LLM project web site