Clinical trial NCT03771131: A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People
Official title: A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Keywords: healthy cognitive ageing
multi-domain cognitive training
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 108
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores
timeFrame: Pre- and post-training (after ~3 months of training)
measure: Mean change from pre-training in Forward and Backward Digit and Corsi Span scores
timeFrame: Pre- and post-training (after ~3 months of training)
measure: Mean change from pre-training in Short Story test scores
timeFrame: Pre- and post-training (after ~3 months of training)
measure: Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores
timeFrame: Pre- and post-training (after ~3 months of training)
measure: Mean change from pre-training in Semantic and Phonological Verbal Fluency scores
timeFrame: Pre- and post-training (after ~3 months of training)
measure: Mean change from pre-training in Stroop color and word test scores
timeFrame: Pre- and post-training (after ~3 months of training)
measure: Mean change from pre-training in Trail Making test scores
timeFrame: Pre- and post-training (after ~3 months of training)
measure: Mean change from pre-training in Raven's coloured matrices scores
timeFrame: Pre- and post-training (after ~3 months of training)
Secondary outcomes:
measure: Mean scores in the Post-training questionnaire
timeFrame: Post-training (after ~3 months of training)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Milan-Bicocca
Study officials:
References:
citation: Tagliabue CF, Guzzetti S, Gualco G, Boccolieri G, Boccolieri A, Smith S, Daini R. A group study on the effects of a short multi-domain cognitive training in healthy elderly Italian people. BMC Geriatr. 2018 Dec 27;18(1):321. doi: 10.1186/s12877-018-1014-x.