Effects of a Daily Cognition Training in Older Adults Without Cognitive Impairment

NCT ID: NCT05688163

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-31

Brief Summary

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To evaluate the effectiveness of a daily cognition training programme versus a traditional cognitive stimulation programme in cognitively unimpaired older adults on cognitive function, emotional state, frailty and functionality.

Detailed Description

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The present study aims to demonstrate the effectiveness of programmes that use everyday cognition for the assessment and intervention of healthy elderly people with the aim of maintaining or improving autonomy, compared to other programmes based on traditional cognitive stimulation, whose benefits do not generalise to significant improvements in everyday life. In addition, the investigators seek to relate how the presence of depression in older people impacts on everyday cognition, and therefore on the functionality of IADLs.

2\. WORKING HYPOTHESIS AND MAIN OBJECTIVES TO BE ACHIEVED

1. WORKING HYPOTHESES

* Alternative hypothesis (H1): Everyday cognition training programmes are more effective than traditional cognitive stimulation on cognitive function, emotional state, frailty and functionality in older adults without cognitive impairment.
* Null hypothesis (Ho): Everyday cognition training programmes are not more effective than traditional cognitive stimulation on cognitive function, emotional state, frailty and functionality in older adults without cognitive impairment.

In order to validate or disprove the main hypothesis, the following objectives have been developed:
2. OBJECTIVES:

i. MAIN OBJECTIVE: To evaluate the effectiveness of a daily cognition training programme versus a traditional cognitive stimulation programme in older adults without cognitive impairment, for cognitive function, emotional state, frailty and functionality.

ii. SPECIFIC OBJECTIVES:

* To compare the differences in the emotional state of older adults without cognitive impairment between the everyday cognition training programme and traditional cognitive stimulation.
* To contrast the differences in the cognitive function of older adults without cognitive impairment between the daily cognition training programme and traditional cognitive stimulation.
* To analyse the differences in the frailty index of older adults without cognitive impairment between the daily cognition training programme and traditional cognitive stimulation.
* To identify the differences in the functionality of older adults without cognitive impairment between the daily cognition training programme and traditional cognitive stimulation.

Conditions

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Functional Status Cognitive Impairment Occupational Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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traditional cognitive stimulation

The control group will carry out the programme based on traditional cognitive stimulation. Individual cognitive skills such as attention, memory, executive functions, orientation, praxis, calculation, visual perception and reasoning will be trained. The materials and media used will be a cognitive stimulation notebook created for the study which includes cards in printed paper format to be completed by the participants.

Group Type ACTIVE_COMPARATOR

traditional cognitive stimulation

Intervention Type OTHER

Individual cognitive skills such as attention, memory, executive functions, orientation, praxis, calculation, visual perception and reasoning will be trained. The materials and media used will be a cognitive stimulation notebook created for the study which includes cards in printed paper format to be completed by the participants.

programme based on everyday cognition

The experimental group, on the other hand, will carry out a programme based on everyday cognition, i.e. the use of cognitive functions to solve real everyday problems that occur in our daily lives and that allow us to be autonomous in our homes, such as preparing food, taking care of the house, using transport, shopping, using the telephone, medication, financial management and access to information and current affairs. As material for use as for the traditional cognitive stimulation sessions, a training booklet on everyday cognition has been created which includes all the sessions mentioned above.

Group Type EXPERIMENTAL

programme based on everyday cognition

Intervention Type OTHER

Will carry out a programme based on everyday cognition, As material for use as for the traditional cognitive stimulation sessions, a training booklet on everyday cognition has been created which includes all the sessions mentioned above. Each day one of these tasks will be worked on.

Interventions

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programme based on everyday cognition

Will carry out a programme based on everyday cognition, As material for use as for the traditional cognitive stimulation sessions, a training booklet on everyday cognition has been created which includes all the sessions mentioned above. Each day one of these tasks will be worked on.

Intervention Type OTHER

traditional cognitive stimulation

Individual cognitive skills such as attention, memory, executive functions, orientation, praxis, calculation, visual perception and reasoning will be trained. The materials and media used will be a cognitive stimulation notebook created for the study which includes cards in printed paper format to be completed by the participants.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be aged 60 years or older.
* Voluntarily sign the informed consent form about the project, authorising their participation.
* Carry out the initial assessment.
* Be admitted to the programme from the start of the programme.

Exclusion Criteria

* No literacy skills or significant deficits in language comprehension.
* Institutionalised person.
* Have a clinical diagnosis of cognitive impairment.
* Participate in another cognitive stimulation programme during the intervention process.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Eduardo J Fernández Rodríguez

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eduardo José Fernández Rodríguez

Salamanca, España, Spain

Site Status

Countries

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Spain

References

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Saez-Gutierrez S, Fernandez-Rodriguez EJ, Sanchez-Gomez C, Garcia-Martin A, Barbero-Iglesias FJ, Sanchez Aguadero N. Study protocol for a randomized controlled trial: Effect of an everyday cognition training program on cognitive function, emotional state, frailty and functioning in older adults without cognitive impairment. PLoS One. 2024 Mar 29;19(3):e0300898. doi: 10.1371/journal.pone.0300898. eCollection 2024.

Reference Type DERIVED
PMID: 38551981 (View on PubMed)

Other Identifiers

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University of Salamanca

Identifier Type: -

Identifier Source: org_study_id

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