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Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment

Primary Purpose

Cognition Disorders in Old Age, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Brain Gym Exercises
Standard exercise program for institutionalized older adults.
Sponsored by
University of Vigo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition Disorders in Old Age focused on measuring cognition disorders, frail elderly, human physical conditioning, institutionalization, physical activity

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundación San Rosendo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brain Gym Exercises

Standard Exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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.
Assessment of the changes in participants' fitness level.
By means of the 5-Chair Stands Test.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2017
Last Updated
December 7, 2017
Sponsor
University of Vigo
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1. Study Identification

Unique Protocol Identification Number
NCT03368482
Brief Title
Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment
Official Title
Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment: Findings From a Comparative Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
March 1, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vigo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Cognitive training and physical exercise have been regarded as useful strategies in order to improve the cognitive function in older people with cognitive impairment. In this regard, it has been argued that while physical exercise improves the metabolic activity of the brain, the performance of cognitively demanding tasks increases the amount of dendritic branches and the level of synaptic plasticity, implying that the combination of both therapies may result in synergistic effects that positively influence various cognitive domains in different ways. One of the best known therapies which combines mental and physical training is Brain Gym® (BG), a movement-based program originally designed to improve learning capabilities through the performance of mind-body exercises. Brain Gym® 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 and none of the studies compared the potential benefits of BG versus traditional exercise programs for this population. Moreover, to the authors' knowledge no study of this kind has been published so far. Under these circumstances, the present study aims at identifying the potential benefits of performing BG exercises on the cognitive function, functional independence, physical fitness, and quality of life of institutionalized older people with cognitive impairment, as well as at finding out whether the effects are more significant than those produced by a traditional exercise program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition Disorders in Old Age, Physical Activity
Keywords
cognition disorders, frail elderly, human physical conditioning, institutionalization, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain Gym Exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brain Gym Exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard exercise program for institutionalized older adults.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of the changes in participants' cognitive function.
Description
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
Time Frame
10 weeks
Title
Assessment of the changes in participants' functional independence.
Description
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
Time Frame
10 weeks
Title
Assessment of the changes in participants' health-related self-perceived quality of life.
Description
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.
Time Frame
10 weeks
Title
Assessment of the changes in participants' fitness level.
Description
By means of the 5-Chair Stands Test.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fundación San Rosendo
City
Panxón
State/Province
Pontevedra
ZIP/Postal Code
36340
Country
Spain

12. IPD Sharing Statement

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Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment

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