Cognition Disorders in Old AgeNCT03368482
Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment
A study testing Brain Gym Exercises and Standard exercise program for institutionalized older adults. in people with Cognition Disorders in Old Age and Physical Activity, run by University of Vigo at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognition Disorders in Old Age, Physical Activity
- What is being tested?
- Brain Gym Exercises and Standard exercise program for institutionalized older adults.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2014to 1 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals whose medical condition hindered or prevented their full and complete participation in the evaluation tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment: Findings From a Comparative Study.
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.
Read the 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.
- Conditions
- Cognition Disorders in Old Age, Physical Activity
- Being tested
- Brain Gym Exercises, Standard exercise program for institutionalized older adults.
- Keywords
- cognition disorders, frail elderly, human physical conditioning, institutionalization, physical activity
- Medical subject headings
- Motor Activity, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Gym ExercisesBehavioural
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.
Standard exercise program for institutionalized older adults.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brain Gym Exercises | Experimental | 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. Receives: Behavioral: Brain Gym Exercises |
| Standard Exercises | Active comparator | 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. Receives: Behavioral: Standard exercise program for institutionalized older adults. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 10 weeks
Assessment of the changes in participants' fitness level.
By means of the 5-Chair Stands Test.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start1 Sep 2014
- Primary completion1 Mar 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition Disorders in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José M. Cancela, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368482
- Sponsor's protocol ID
- 2-2402-16
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment: Findings From a Comparative Study.
- ClinicalTrials.gov ID
- NCT03368482
- Acronym / sponsor ID
- 2-2402-16
- Conditions
- Cognition Disorders in Old Age, Physical Activity
- Keywords
- cognition disorders, frail elderly, human physical conditioning, institutionalization, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Mar 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Gym Exercises | Experimental | Behavioral: Brain Gym ExercisesBrain 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 comparator | Behavioral: Standard exercise program for institutionalized older adults.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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals whose medical condition hindered or prevented their full and complete participation in the evaluation tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Gym ExercisesParticipants 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. | Behavioural | Brain Gym Exercises |
| Standard exercise program for institutionalized older adults.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. | Behavioural | Standard Exercises |
Primary outcome
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
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
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.
Assessment of the changes in participants' fitness level.
Time frame: 10 weeks
By means of the 5-Chair Stands Test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Gym Exercises and Standard exercise program for institutionalized older adults. in people with Cognition Disorders in Old Age and Physical Activity, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the changes in participants' cognitive function. (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.