Mild Cognitive ImpairmentNCT02051270
Cognitive Impairment and Balance in Elderly
An observational study of Mild Cognitive Impairment, run by Universidad de Granada at 1 site in Spain.
Trial summary
One important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. The objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Descriptive study
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to May 2015
- Phase
- Observational
- 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
Study population: Elders
Who may be able to join
- Nursing home residents.
Who cannot join
- Surgery on lower limbs.
- Traumatic damage on lower limbs.
- Severe cognitive impairment in order not to complete the assessment.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of health Sciences. University of Granada
Granada, Spain, 18071
About this study
Official title: Mild Cognitive Impairment and Balance in Elderly
One important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. The objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly.
Read the detailed description
Mild cognitive impairment is described as a transitional stage between normal ageing and dementia, and reflects the clinical situation where a person has memory complaints and objective evidence of cognitive impairment but no evidence of dementia. Mild cognitive is important in older people and it is also important to evaluate its repercussion in balance.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Descriptive study
- Keywords
- Elderly, Nursing homes, Mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive studyOther
More than 65 years old elders
| Study group | Role | What they receive |
|---|---|---|
| Elders | Older people living in nursing homes will undergo a descriptive study. Receives: Other: Descriptive study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
Dynamic balance is going to be measured using the Mini-Best test. This is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation, and dynamic gait
Measured: baseline
Secondary outcomes (3)
Cognitive impairment
The cognitive impairment will be measured using the Montreal Cognitive Assessment and the Mini-Mental State Examination. The Montreal Cognitive Assessment is a test designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The Mini Mental State Examination is a 10-minute bedside measure of impaired thinking in undeveloped, uneducated, diseased, or very old populations.
Measured: baseline
Attention
Attention is going to be measured with the Stroop test.
Measured: baseline
Cognitive flexibility
The cognitive flexibility of patients is measured using the Trial Making Test. This test explores visual-conceptual and visual-motor tracking, and it is a frequently used neuropsychological test.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051270
- Sponsor's protocol ID
- DF0050UG
- Status last verified
- Nov 2016
- First submitted
- 27 Jan 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diaz-Pelegrina A, Cabrera-Martos I, Lopez-Torres I, Rodriguez-Torres J, Valenza MC. [Effects of cognitive state on balance disturbances and gait disorders in institutionalised elderly]. Rev Esp Geriatr Gerontol. 2016 Mar-Apr;51(2):88-91. doi: 10.1016/j.regg.2015.07.014. Epub 2015 Nov 2. Spanish.
PubMed 26541310
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Cognitive Impairment and Balance in Elderly
- ClinicalTrials.gov ID
- NCT02051270
- Acronym / sponsor ID
- DF0050UG
- Conditions
- Mild Cognitive Impairment
- Keywords
- Elderly, Nursing homes, Mild cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
One important issue in older adults with cognitive problems is the higher risk of fall due to decreased motor function and balance. The objective of this study is to evaluate the repercussions of mild cognitive impairment in balance in elderly.
Detailed description
Mild cognitive impairment is described as a transitional stage between normal ageing and dementia, and reflects the clinical situation where a person has memory complaints and objective evidence of cognitive impairment but no evidence of dementia. Mild cognitive is important in older people and it is also important to evaluate its repercussion in balance.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elders | – | Other: Descriptive studyOlder people living in nursing homes will undergo a descriptive study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elders
Key inclusion criteria (1 listed)
- Nursing home residents.
Key exclusion criteria (3 listed)
- Surgery on lower limbs.
- Traumatic damage on lower limbs.
- Severe cognitive impairment in order not to complete the assessment.
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 |
|---|---|---|
| Descriptive studyMore than 65 years old elders | Other | Elders |
Primary outcome
Dynamic balance
Time frame: baseline
Dynamic balance is going to be measured using the Mini-Best test. This is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation, and dynamic gait
3 secondary outcomes
Cognitive impairment
Time frame: baseline
Attention
Time frame: baseline
Cognitive flexibility
Time frame: baseline
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 2 Nov 2016.
- Background: PubMed 26541310Diaz-Pelegrina A, Cabrera-Martos I, Lopez-Torres I, Rodriguez-Torres J, Valenza MC. [Effects of cognitive state on balance disturbances and gait disorders in institutionalised elderly]. Rev Esp Geriatr Gerontol. 2016 Mar-Apr;51(2):88-91. doi: 10.1016/j.regg.2015.07.014. Epub 2015 Nov 2. Spanish.
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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.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Universidad de Granada 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 1 inclusion and 3 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 2 Nov 2016. 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?
Dynamic balance (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051270, which also lists 1 linked publication.
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 2 Nov 2016.