NCT02267499

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

October 14, 2014

Last Update Submit

October 17, 2014

Conditions

Keywords

cognitive trainingphysical trainingexercise gamesnovelty serious gamescomputer trainingmild cognitive impairmentmild dementiahealthy elderly

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • physical fitness

    2 months

  • Episodic memory

    2 months

  • working memory

    2 months

  • executive function

    2 months

  • Quality of Life

    2 months

  • +3 more secondary outcomes

Study Arms (2)

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)

Other: LLM training

Passive Control

NO INTERVENTION

Participants do not receive an intervention serving as passive controls

Interventions

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)

Also known as: PTC+CTC
LLM training

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Professor

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

November 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2013

Last Updated

October 20, 2014

Record last verified: 2014-10