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
Verified date | April 2023 |
Source | University of Salamanca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Eduardo José Fernández Rodríguez | Salamanca | España |
Lead Sponsor | Collaborator |
---|---|
University of Salamanca |
Spain,
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 |
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