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

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.

Study Overview

• Status: Completed
• Conditions: Age-related Cognitive Decline
• Intervention / Treatment: Behavioral: Multi-domain 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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20126
    • University of Milan-Bicocca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Group receiving the multi-domain cognitive training	Behavioral: Multi-domain cognitive training; Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)
No Intervention: Control group; Passive control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores	Raw score, assessing global cognitive functioning. Cutoff: < 17.362. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.	Pre- and post-training (after ~3 months of training)
Mean change from pre-training in Forward and Backward Digit and Corsi Span scores	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.	Pre- and post-training (after ~3 months of training)
Mean change from pre-training in Short Story test scores	Raw score, assessing verbal long term memory. Cutoff: < 7.5. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.	Pre- and post-training (after ~3 months of training)
Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores	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.	Pre- and post-training (after ~3 months of training)
Mean change from pre-training in Semantic and Phonological Verbal Fluency scores	Raw score, assessing executive functions. Cutoff: < 16 (Phonological), < 24 (Semantic). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.	Pre- and post-training (after ~3 months of training)
Mean change from pre-training in Stroop color and word test scores	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.	Pre- and post-training (after ~3 months of training)
Mean change from pre-training in Trail Making test scores	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.	Pre- and post-training (after ~3 months of training)
Mean change from pre-training in Raven's coloured matrices scores	Raw score, assessing non-verbal reasoning. Cutoff: < 18. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.	Pre- and post-training (after ~3 months of training)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean scores in the Post-training questionnaire	Scores assessing both the satisfaction level about the training and the possible impact of the program on participants' everyday activities, mood and socialization. Each question was measured on a 5-point Likert scale (1: most negative score; 5: most positive score).	Post-training (after ~3 months of training)

Collaborators and Investigators

• Sponsor: University of Milano Bicocca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: healthy cognitive ageing; multi-domain cognitive training
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: DD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No