- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503641
Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function in the Functional Capacity of Older Adults
Cognitive and Psychomotor Stimulation in the Physical and Cognitive Function and in the Functional Capacity of Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Jaén, Spain
- Recruiting
- U.E.D. Virgen de la Capilla
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Contact:
- José Galán
- Phone Number: 953190649
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
This group receives training in cognitive and psychomotricity stimulation activities.
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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. |
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No Intervention: Control group
This group does not receive any treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tinetti Scale
Time Frame: Up to twelve weeks
|
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.
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Up to twelve weeks
|
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Handgrip Strength
Time Frame: Up to twelve weeks
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Dynamometer will be employed to assess handgrip strength.
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Up to twelve weeks
|
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MMSE (mini-mental state examination)
Time Frame: Up to twelve weeks
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A tool that can be used to systematically and thoroughly assess mental status.
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Up to twelve weeks
|
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TUG test (Timed Up and Go test)
Time Frame: Up to twelve weeks
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Is a simple test used to assess a person's mobility and physical function.
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Up to twelve weeks
|
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The Lawton & Brody scale
Time Frame: Up to twelve weeks
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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.
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Up to twelve weeks
|
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The Barthel Index
Time Frame: Up to twelve weeks
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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.
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Up to twelve weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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BMI (Body Mass Index)
Time Frame: Up to twelve weeks
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Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2.
It is a rough indicator of total body fat.
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Up to twelve weeks
|
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Body Weight
Time Frame: Up to twelve weeks
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Is the sum of Body Fat and Fat Free Mass.
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Up to twelve weeks
|
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Height
Time Frame: Up to twelve weeks
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It measures a person's height, measured from the sole of the foot to the top of the head.
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Up to twelve weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- - University of Jaén
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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