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Functional StatusNCT05688163

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

A study testing programme based on everyday cognition and traditional cognitive stimulation in people with Functional Status and Cognitive Impairment, run by University of Salamanca at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
programme based on everyday cognition and traditional cognitive stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteSpain
Study dates
1 Jun 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Eduardo José Fernández Rodríguez

    Salamanca, España, 37002

Other trials in Spain

About this study

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

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.

Read the detailed 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.

  1. WORKING HYPOTHESIS AND MAIN OBJECTIVES TO BE ACHIEVED
  2. 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:
  1. OBJECTIVES:
  2. 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.
Being tested
programme based on everyday cognition, traditional cognitive stimulation
Keywords
Functional Status, Cognition Therapy, Cognitive Impairment, Occupational therapy
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • programme based on everyday cognitionOther

    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 stimulationOther

    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.

Study groups in NCT05688163
Study groupRoleWhat they receive
traditional cognitive stimulationActive comparatorThe 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.
Receives: Other: traditional cognitive stimulation
programme based on everyday cognitionExperimentalThe 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.
Receives: Other: programme based on everyday cognition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 35 minutes

Secondary outcomes (5)

  1. 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).

    Measured: 10 minutes

  2. 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.

    Measured: 10minutes

  3. 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).

    Measured: 5 minutes

  4. 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.

    Measured: 15 minutes

  5. 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05688163
Sponsor's protocol ID
University of Salamanca
Status last verified
Apr 2023
First submitted
8 Jan 2023
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be made available upon request by contacting the following e-mail address: edujfr@usal.es.

Publications

  • 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.

    PubMed 38551981

Questions about this trial

What is this clinical trial studying?

A study testing programme based on everyday cognition and traditional cognitive stimulation in people with Functional Status and Cognitive Impairment, run by University of Salamanca at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Everyday cognition. (time frame: 35 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05688163, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.

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