Accidental FallsICGFNCT02700672
Influence of Cognition and Gait on Falls
An observational study of Accidental Falls, run by Federal University of São Paulo.
Trial summary
The study analyses if cognition and gait speed can predict falls in a community-dwelling people and ambulant long term care residents Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Observational study
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Mar 2013
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty-five individuals living in a long term care facility and twenty-five older adults from community
Who may be able to join
- People who could walk with or without ambulation devices
- Mini-Mental State Examination score according to schooling
Who cannot join
- Terminal illnesses
- Bedridden
- Unable to see or hear
- Use of benzodiazepines
About this study
Official title: Predicting Falls Among Institutionalized and Non-institutionalized Older Adults: The Role of Cognition and Gait Speed
The study analyses if cognition and gait speed can predict falls in a community-dwelling people and ambulant long term care residents
Read the detailed description
Falls are some of the most common events among elderly people. The odds of recurrent falls increase every year, which can cause impairment in basic activities of daily living, social isolation, fear of falling again and death. The aim of the present study is to analyze the role of cognition and gait speed as predictors to falls in institutionalized and non-institutionalized elderly people.
Methods:Twenty-five individuals living in a long-term care facility and 25 non-institutionalized individuals participated in the study. A questionnaire about their history of falls, tests to evaluate cognition (global and executive function) and a pedometer with an accelerometer to measure kinematic variables were applied.
- Conditions
- Accidental Falls
- Being tested
- Observational study
- Keywords
- Ageing, Cognition, Executive Function, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study: kinematic variables, falls and executive function were analyzed
| Study group | Role | What they receive |
|---|---|---|
| Institutionalized older adults | Observational study Receives: Other: Observational study | |
| Non-institutionalized older adults | Observational study Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive predictor of falls assessed with the Mini-Mental State Examination
To measure cognitive predictor will be used Mini-Mental State Examination
Measured: falls on past 12 months
Secondary outcomes (2)
Executive function predictor of falls assessed with the Wisconsin Card Sort Test
To measure executive function will be used Wisconsin Card Sort Test
Measured: falls on past 12 months
Gait speed predictor of falls assessed with an accelerometer
To measure gait speed will be used an accelerometer
Measured: falls on past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos Fernandes Galduroz MD, Federal University of São Paulo
- Investigators
- José Carlos Galduróz, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700672
- Sponsor's protocol ID
- Falls&Cognition&Gait
- Acronym
- ICGF
- Status last verified
- Mar 2016
- First submitted
- 7 Jan 2016
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Falls Among Institutionalized and Non-institutionalized Older Adults: The Role of Cognition and Gait Speed
- ClinicalTrials.gov ID
- NCT02700672
- Acronym / sponsor ID
- ICGF / Falls&Cognition&Gait
- Conditions
- Accidental Falls
- Keywords
- Ageing, Cognition, Executive Function, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 7 Mar 2016 (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.
The study analyses if cognition and gait speed can predict falls in a community-dwelling people and ambulant long term care residents
Detailed description
Falls are some of the most common events among elderly people. The odds of recurrent falls increase every year, which can cause impairment in basic activities of daily living, social isolation, fear of falling again and death. The aim of the present study is to analyze the role of cognition and gait speed as predictors to falls in institutionalized and non-institutionalized elderly people.
Methods:Twenty-five individuals living in a long-term care facility and 25 non-institutionalized individuals participated in the study. A questionnaire about their history of falls, tests to evaluate cognition (global and executive function) and a pedometer with an accelerometer to measure kinematic variables were applied.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Institutionalized older adults | – | Other: Observational studyObservational study |
| Non-institutionalized older adults | – | Other: Observational studyObservational study |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-five individuals living in a long term care facility and twenty-five older adults from community
Key inclusion criteria (2 listed)
- People who could walk with or without ambulation devices
- Mini-Mental State Examination score according to schooling
Key exclusion criteria (4 listed)
- Terminal illnesses
- Bedridden
- Unable to see or hear
- Use of benzodiazepines
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 |
|---|---|---|
| Observational studyObservational study: kinematic variables, falls and executive function were analyzed | Other | Institutionalized older adults, Non-institutionalized older adults |
Primary outcome
Cognitive predictor of falls assessed with the Mini-Mental State Examination
Time frame: falls on past 12 months
To measure cognitive predictor will be used Mini-Mental State Examination
2 secondary outcomes
Executive function predictor of falls assessed with the Wisconsin Card Sort Test
Time frame: falls on past 12 months
Gait speed predictor of falls assessed with an accelerometer
Time frame: falls on past 12 months
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 7 Mar 2016.
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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.
José Carlos Galduróz, PhD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls, run by Federal University of São Paulo.
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 2 inclusion and 4 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 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Cognitive predictor of falls assessed with the Mini-Mental State Examination (time frame: falls on past 12 months). 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 7 Mar 2016.