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Clinical Trials/NCT03771131
NCT03771131
Completed
N/A

A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People

University of Milano Bicocca1 site in 1 country108 target enrollmentDecember 1, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Age-related Cognitive Decline
Sponsor
University of Milano Bicocca
Enrollment
108
Locations
1
Primary Endpoint
Mean change from pre-training in Trail Making test scores
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Alongside physiological cognitive ageing, nowadays there is an alarming increase in the incidence of dementia that requires communities to invest in its prevention. The engagement in cognitively stimulating activities and strong social networks have been identified among those protective factors promoting successful cognitive ageing. One aspect regarding cognitive stimulation concerns the relevance of the frequency of an external intervention. For these reasons, the aim of this study was to evaluate the efficacy of a 3-month multi-domain cognitive training program, administered once per week in a group of healthy elderly aged over 60 years old. Their results obtained on a series of neuropsychological tests, both pre- (t0) and post-training (t1), were compared with those of a passive control group who did not receive the cognitive training.

Detailed Description

Participants were assigned to the experimental or control group based on their time of application to the program. Both experimental and control group underwent a neuropsychological assessment to investigate different cognitive domains, before and after (\~3 months) the training program. Based on the scores obtained during the preliminary neuropsychological assessment, the participants of the experimental training group were divided into small subgroups (ranging from 8 to 12 subjects) to further address individualization of training (i.e. level of difficulty of the exercises proposed). The experimental group attended weekly sessions of the multi-domain cognitive training. Each session lasted around one hour and the overall duration of the training was of 3 months, for a total of 13 sessions. To promote improvement transfer to everyday life, some of the exercises proposed were ecological in their nature, in that, they asked participants to solve tasks that recalled everyday situations (such as remembering names or road maps). Furthermore, throughout the training, approximately once every two sessions brief psycho-educational interventions were provided.

Registry
clinicaltrials.gov
Start Date
December 1, 2013
End Date
January 1, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roberta Daini

Professor

University of Milano Bicocca

Eligibility Criteria

Inclusion Criteria

  • Age over 60 years

Exclusion Criteria

  • Negative anamnesis for neurological and/or psychiatric diseases
  • No suspected cognitive impairment as assessed during the pre-training neuropsychological testing (\>2 pathological scores)

Outcomes

Primary Outcomes

Mean change from pre-training in Trail Making test scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing attention. Cutoff: \> 93 (TMT A), \> 282 (TMT B), \> 186 (TMT B-A). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Stroop color and word test scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing inhibitory control. Cutoff: \> 36.92 (for Time measure), \> 4.24 (for Error measure). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Raven's coloured matrices scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing non-verbal reasoning. Cutoff: \< 18. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Short Story test scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing verbal long term memory. Cutoff: \< 7.5. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Semantic and Phonological Verbal Fluency scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing executive functions. Cutoff: \< 16 (Phonological), \< 24 (Semantic). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing global cognitive functioning. Cutoff: \< 17.362. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Forward and Backward Digit and Corsi Span scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing verbal and visuo-spatial short term memory. Cutoff: \< 4.26 (Forward Digit Span), \< 2.65 (Backward Digit Span), \< 3.46 (Forward Corsi Span), \< 3.08 (Backward Corsi Span). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores

Time Frame: Pre- and post-training (after ~3 months of training)

Raw score, assessing constructional abilities and visuo-spatial long term memory. Cutoff: \< 28.87 (Copy), \< 9.46 (Recall). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.

Secondary Outcomes

  • Mean scores in the Post-training questionnaire(Post-training (after ~3 months of training))

Study Sites (1)

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