Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment
1 other identifier
interventional
50
1 country
1
Brief Summary
Scientific evidence regarding the effects of Brain Gym®, on people with cognitive impairment is scarce. This study aimed at comparing the effects of a program based on Brain Gym® exercises against a fitness exercise program on the cognitive function, functional independence, physical fitness and quality of life in institutionalized older adults with cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedDecember 11, 2017
December 1, 2017
6 months
November 28, 2017
December 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Assessment of the changes in participants' cognitive function.
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.
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.
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.
By means of the 5-Chair Stands Test.
10 weeks
Study Arms (2)
Brain Gym Exercises
EXPERIMENTALBrain 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.
Standard Exercises
ACTIVE COMPARATORA traditional physical exercise program designed for institutionalized elderly people aimed at increasing their range of mobility and coordination, specifically focused on the lower limbs.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Individuals whose medical condition hindered or prevented their full and complete participation in the evaluation tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundación San Rosendo
Panxón, Pontevedra, 36340, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 11, 2017
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
July 1, 2015
Last Updated
December 11, 2017
Record last verified: 2017-12