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

Primary Purpose

Age-related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Multi-domain cognitive training
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-related Cognitive Decline focused on measuring healthy cognitive ageing, multi-domain cognitive training

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Milan-Bicocca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Group receiving the multi-domain cognitive training

Passive control group

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
December 6, 2018
Last Updated
December 7, 2018
Sponsor
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT03771131
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2013 (Actual)
Primary Completion Date
January 1, 2015 (Actual)
Study Completion Date
January 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milano Bicocca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline
Keywords
healthy cognitive ageing, multi-domain cognitive training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Group receiving the multi-domain cognitive training
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Passive control group
Intervention Type
Behavioral
Intervention Name(s)
Multi-domain cognitive training
Intervention Description
Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)
Primary Outcome Measure Information:
Title
Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores
Description
Raw score, assessing global cognitive functioning. Cutoff: < 17.362. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
Time Frame
Pre- and post-training (after ~3 months of training)
Title
Mean change from pre-training in Forward and Backward Digit and Corsi Span scores
Description
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.
Time Frame
Pre- and post-training (after ~3 months of training)
Title
Mean change from pre-training in Short Story test scores
Description
Raw score, assessing verbal long term memory. Cutoff: < 7.5. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
Time Frame
Pre- and post-training (after ~3 months of training)
Title
Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores
Description
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.
Time Frame
Pre- and post-training (after ~3 months of training)
Title
Mean change from pre-training in Semantic and Phonological Verbal Fluency scores
Description
Raw score, assessing executive functions. Cutoff: < 16 (Phonological), < 24 (Semantic). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
Time Frame
Pre- and post-training (after ~3 months of training)
Title
Mean change from pre-training in Stroop color and word test scores
Description
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.
Time Frame
Pre- and post-training (after ~3 months of training)
Title
Mean change from pre-training in Trail Making test scores
Description
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.
Time Frame
Pre- and post-training (after ~3 months of training)
Title
Mean change from pre-training in Raven's coloured matrices scores
Description
Raw score, assessing non-verbal reasoning. Cutoff: < 18. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
Time Frame
Pre- and post-training (after ~3 months of training)
Secondary Outcome Measure Information:
Title
Mean scores in the Post-training questionnaire
Description
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).
Time Frame
Post-training (after ~3 months of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
University of Milan-Bicocca
City
Milan
ZIP/Postal Code
20126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30587151
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.
Results Reference
derived

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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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