Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function in the Functional Capacity of Older Adults
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive and psychomotor stimulation
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- Have a mild dependency according to the Barthel Index (score greater than 60 points).
- Not present serious cognitive impairment, nor serious psychiatric or somatic disorders, nor disruptive and inappropriate behaviors.
- Be able to understand each of the self-administered questionnaires and perform the tests.
Exclusion Criteria:
- Have vision problems.
- Be enrolled in a physical exercise program.
Sites / Locations
- U.E.D. Virgen de la Capilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
This group receives training in cognitive and psychomotricity stimulation activities.
This group does not receive any treatment.
Outcomes
Primary Outcome Measures
Tinetti Scale
Scale for the assessment of gait and balance. Indicated for early detection of the risk of falls in the elderly. The higher the score, the lower the risk of falls. The maximum score for the gait subscale is 12, for the balance subscale 16. The sum of both scores for the risk of falls.
Handgrip Strength
Dynamometer will be employed to assess handgrip strength.
MMSE (mini-mental state examination)
A tool that can be used to systematically and thoroughly assess mental status.
TUG test (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function.
The Lawton & Brody scale
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence.
The Barthel Index
Assesses functional dependence when performing basic activities of daily living (BADL), consists of 10 items with scores between 0 and 15 maximum each (Mahoney and Barthel, 1965). The highest possible score is 100 points, this being the greatest independence, if the score is greater than 60 the dependency is slight, if the score is between 40 and 55 the dependency is moderate, when between 20 and 35 points the dependency is serious and if it is less than 20 points the dependency is total.
Secondary Outcome Measures
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Body Weight
Is the sum of Body Fat and Fat Free Mass.
Height
It measures a person's height, measured from the sole of the foot to the top of the head.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05503641
Brief Title
Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function in the Functional Capacity of Older Adults
Official Title
Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function and in the Functional Capacity of Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The population is increasingly older and this means that there are more and more dependent older people, for this reason it is necessary to achieve the best quality of life for the older adult population by promoting active and healthy aging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
This group receives training in cognitive and psychomotricity stimulation activities.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group does not receive any treatment.
Intervention Type
Other
Intervention Name(s)
Cognitive and psychomotor stimulation
Intervention Description
Each cognitive stimulation session aimed to maintain and/or improve cognition through memory, language, executive functions, attention, concentration, and perception activities. All the people in the two groups performed the same cognitive stimulation activities adapted to their cognitive and sensory abilities.
The psychomotricity sessions were aimed at maintaining and/or improving the motor, cognitive, social and affective functioning of the person through activities that work on postural tone, body scheme, laterality, fine and gross motor skills, balance, flexibility, among others, adding a cognitive component. All the psychomotricity activities were adapted to the motor and cognitive abilities of the users.
Primary Outcome Measure Information:
Title
Tinetti Scale
Description
Scale for the assessment of gait and balance. Indicated for early detection of the risk of falls in the elderly. The higher the score, the lower the risk of falls. The maximum score for the gait subscale is 12, for the balance subscale 16. The sum of both scores for the risk of falls.
Time Frame
Up to twelve weeks
Title
Handgrip Strength
Description
Dynamometer will be employed to assess handgrip strength.
Time Frame
Up to twelve weeks
Title
MMSE (mini-mental state examination)
Description
A tool that can be used to systematically and thoroughly assess mental status.
Time Frame
Up to twelve weeks
Title
TUG test (Timed Up and Go test)
Description
Is a simple test used to assess a person's mobility and physical function.
Time Frame
Up to twelve weeks
Title
The Lawton & Brody scale
Description
Evaluates independence and functionality in instrumental activities of daily life) such as shopping, cooking, cleaning, washing, finances, medication, transportation and use of the telephone; and considers instrumental disability the inability to perform one or more activities. Each area is scored according to the description that best corresponds to the subject. Therefore, each area scores a maximum of 1 point and a minimum of 0 points. The maximum dependence would be marked by obtaining 0 points, while a sum of 8 points would express total independence.
Time Frame
Up to twelve weeks
Title
The Barthel Index
Description
Assesses functional dependence when performing basic activities of daily living (BADL), consists of 10 items with scores between 0 and 15 maximum each (Mahoney and Barthel, 1965). The highest possible score is 100 points, this being the greatest independence, if the score is greater than 60 the dependency is slight, if the score is between 40 and 55 the dependency is moderate, when between 20 and 35 points the dependency is serious and if it is less than 20 points the dependency is total.
Time Frame
Up to twelve weeks
Secondary Outcome Measure Information:
Title
BMI (Body Mass Index)
Description
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Time Frame
Up to twelve weeks
Title
Body Weight
Description
Is the sum of Body Fat and Fat Free Mass.
Time Frame
Up to twelve weeks
Title
Height
Description
It measures a person's height, measured from the sole of the foot to the top of the head.
Time Frame
Up to twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a mild dependency according to the Barthel Index (score greater than 60 points).
Not present serious cognitive impairment, nor serious psychiatric or somatic disorders, nor disruptive and inappropriate behaviors.
Be able to understand each of the self-administered questionnaires and perform the tests.
Exclusion Criteria:
Have vision problems.
Be enrolled in a physical exercise program.
Facility Information:
Facility Name
U.E.D. Virgen de la Capilla
City
Jaén
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function in the Functional Capacity of Older Adults
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