Physical Activity Clinical Trial
Official title:
Brain Gym® Exercises for Institutionalized Elderly People With Cognitive Impairment: Findings From a Comparative Study.
Verified date | December 2017 |
Source | University of Vigo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 1, 2015 |
Est. primary completion date | March 1, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Fundación San Rosendo | Panxón | Pontevedra |
Lead Sponsor | Collaborator |
---|---|
University of Vigo |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Assessment of the changes in participants' fitness level. | By means of the 5-Chair Stands Test. | 10 weeks |
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