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

Cognitive Impairment Clinical Trial

Official title:

Effects of a Daily Cognition Training Programme on Cognitive Function, Emotional State, Frailty and Functionality in Older Adults Without Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05688163
• Other study ID #: University of Salamanca
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 99
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Functional Status
• Occupational Therapy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Eduardo José Fernández Rodríguez	Salamanca	España

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Everyday cognition.	The Test for the Assessment of Everyday Cognition measures the ability of older people to solve everyday problems through performance tasks whose resolution depends on their cognitive capacity. The abilities tested are planning ability and cognitive flexibility, verbal working memory, reasoning, episodic memory, episodic memory and crystallised intelligence. The result is a direct estimation of the person's functional capacity by means of 12 real situations grouped into 6 areas: medication, administrative management, financial management, meal preparation, transport and shopping. The administration time is about 35 minutes.	35 minutes
Secondary	Cognitive function.	MONTREAL COGNITIVE ASSESSMENT TEST (MoCA test) Versión 8.3. :It is a cognitive assessment tool created to detect mild cognitive impairment (MCI). It evaluates executive functions, attention, abstraction, memory, language, visual-constructive abilities, calculation and orientation. It takes approximately 10 minutes to administer. The maximum score is 30 points, below 26 points being the cut-off for MCI (in developed countries).	10 minutes
Secondary	Emotional state.	Yesavage: It is a screening questionnaire for depression in people over 65 years of age. The 15-item version was selected for this study. It expresses the degree of satisfaction, quality of life and feelings. Of the 15 items, 10 indicate the presence of depression if answered positively, while the remaining 5 items answered negatively indicate depression. The administration time is 5 minutes. A score above 5 shows moderate depression and above 10 severe depression.	10minutes
Secondary	Instrumental activities of daily living	LAWTON AND BRODY SCALE: This is an assessment designed to evaluate autonomy in IADLs in the elderly population. It consists of eight items: use of the telephone, shopping, meal preparation, housekeeping, laundry, transport, medication management, use of transport and money. It takes 4 minutes to administer and is scored 0 or 1 for each item, making a total score of 8. At present, it is influenced by a gender bias as it is more sensitive to women than men (many of the activities have been performed only by women throughout history).	5 minutes
Secondary	Functionality.	FUNCTIONAL INDEPENDENCE MEASURE (FIM): This is a tool created to measure the level of functionality and assistance given by the caregiver. It assesses the activities of daily living subdivided into two dimensions: the motor dimension; which assesses self-care (feeding, personal grooming, bathing, upper body dressing, lower body dressing, perineal grooming), sphincter control (bladder and bowel), transfers (to and from the chair or wheelchair, transfer in the bathroom, bath or shower) and locomotion (walking or moving around in a wheelchair, going up or down stairs). And cognitive; which assesses communication (comprehension, expression) and social knowledge (social interaction, problem solving and memory). Each of the 18 items has a maximum score of 7 and a minimum score of 1, making a total of 126.	15 minutes
Secondary	Fragility.	FRAILTY SCALE: This is an assessment designed to quantitatively measure frailty in geriatric patients. It consists of 5 questions on real-life situations in which some frailty may affect quality of life. The maximum score is 5 points.	5 minutes