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

Age-related Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771131
• Other study ID #: DD
• Status: Completed
• Phase: N/A
• Start date: December 1, 2013
• Est. completion date: January 1, 2015

Study information

• Verified date: December 2018
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 1, 2015
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

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)

Locations

Country	Name	City	State
Italy	University of Milan-Bicocca	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)