NCT03368482

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

November 28, 2017

Last Update Submit

December 7, 2017

Conditions

Keywords

cognition disordersfrail elderlyhuman physical conditioninginstitutionalizationphysical activity

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

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.

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.

Behavioral: Standard exercise program for institutionalized older adults.

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.

Brain Gym Exercises

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.

Standard Exercises

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Conditions

Motor ActivityCognition Disorders

Condition Hierarchy (Ancestors)

BehaviorNeurocognitive DisordersMental Disorders

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

Locations