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

NCT03771131 | Completed

• 1 other identifier: DD
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Cognitive Decline

Keywords

healthy cognitive ageing; multi-domain cognitive training

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Mean scores in the Post-training questionnaire

  Post-training (after ~3 months of training)

Study Arms (2)

Experimental group

EXPERIMENTAL

Group receiving the multi-domain cognitive training

Behavioral: Multi-domain cognitive training

Control group

NO INTERVENTION

Passive control group

Interventions

Multi-domain cognitive training BEHAVIORAL

Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)

Experimental group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 60 years

You may not qualify if:

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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

University of Milan-Bicocca

Milan, 20126, Italy

Location

Related Publications (1)

• 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.

  PMID: 30587151 DERIVED

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: Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: December 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 10, 2018

Record last verified: 2018-12

Locations

IT (1)