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

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ClinicalTrials.gov Identifier: NCT03771131
Recruitment Status : Completed
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Roberta Daini, University of Milano Bicocca

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.

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Behavioral: Multi-domain cognitive training Not Applicable

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  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People
Actual Study Start Date : December 1, 2013
Actual Primary Completion Date : January 1, 2015
Actual Study Completion Date : January 1, 2015

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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. Mean scores in the Post-training questionnaire [ Time Frame: Post-training (after ~3 months of training) ]
    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).



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771131


Locations
Italy
University of Milan-Bicocca
Milan, Italy, 20126
Sponsors and Collaborators
University of Milano Bicocca

Responsible Party: Roberta Daini, Professor, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT03771131     History of Changes
Other Study ID Numbers: DD
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roberta Daini, University of Milano Bicocca:
healthy cognitive ageing
multi-domain cognitive training

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders