- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368482
Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment
Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment: Findings From a Comparative Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pontevedra
-
Panxón, Pontevedra, Spain, 36340
- Fundación San Rosendo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Older than 65 years old.
- Mean score ≤ 24 in the Spanish adapted version of the Mini-Mental State Examination.
- Cognitive and co-operative ability to follow simple instructions.
Exclusion criteria:
• Individuals whose medical condition hindered or prevented their full and complete participation in the evaluation tests.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brain Gym Exercises
Brain Gym® (BG) is a movement-based program originally designed to improve learning capabilities through the performance of mind-body exercises.
BG can be considered as an interesting field of research due to the need of identifying novel therapies which might be more pleasant for older adults who tend not to be prone to participating in conventional exercise programs and might have a positive effect on their cognitive function.
In spite of this, scientific evidence regarding the effects of BG on people with cognitive impairment is scarce.
|
Participants in the BrainGym Exercises group performed six of the following BG exercises in every training session they took part in: "Cross Crawl", "Gravity Glider", "Arm Activation", "Belly Breathing", "Hook-ups", "Think of an X", "Lazy Eights", "Elephant", "Space Buttons", "The Owl", "Energy Yawn", "Balance Buttons" and "The Energizer".
All exercises were executed from a sitting position but following the main tenets of the Brain Gym® work routine.
|
|
Active Comparator: Standard Exercises
A traditional physical exercise program designed for institutionalized elderly people aimed at increasing their range of mobility and coordination, specifically focused on the lower limbs.
|
Participants in the Standard Exercise group took part in a traditional physical exercise program designed for institutionalized elderly people aimed at increasing their range of mobility and coordination, specifically focused on the lower limbs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of the changes in participants' cognitive function.
Time Frame: 10 weeks
|
By means of the Spanish version of the Mini-Mental State Examination. This is a 30-point questionnaire comprised by eight different categories and score range: Orientation to time (0-5 points) Orientation to place (0-5 points) Registration (0-3 points) Attention and calculation (0-5 points) Recall (0-3 points) Language (0-2 points) Repetition (0-1 points) Complex commands (0-6 points) The total score is the result of the summation of the categories. Interpretation: Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. ≤9 points: severe cognitive impairment 10-18 points: moderate cognitive impairment 19-23 points: mild cognitive impairment |
10 weeks
|
|
Assessment of the changes in participants' functional independence.
Time Frame: 10 weeks
|
By means of the Barthel Index (BI) Spanish version. This scale evaluates the independence for the activities of daily living. It contains 10 different activities, with a possible score ranging from 0 to 10, with a maximum total score of the scale of 100 (summing the subscales results). Interpretation: <20 Total dependence 21 - 60 Severe dependence 61 - 90 Moderate dependence 91 - 99 Mild dependence 100 Total Independence |
10 weeks
|
|
Assessment of the changes in participants' health-related self-perceived quality of life.
Time Frame: 10 weeks
|
By means of the 12-Item Short-Form Health Survey (SF-12), spanish version.
For each of the 8 subscales, the value can go from 0 to 100.
For the interpretation of the results, the 50 (standard deviation 10) value on each dimension must be the mean valor for the sub scale reported for the general population, meaning that more or less than 50 must be considered better or worse, respectively.
|
10 weeks
|
|
Assessment of the changes in participants' fitness level.
Time Frame: 10 weeks
|
By means of the 5-Chair Stands Test.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-2402-16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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