NCT02700672

Brief Summary

The study analyses if cognition and gait speed can predict falls in a community-dwelling people and ambulant long term care residents

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

January 7, 2016

Last Update Submit

March 2, 2016

Conditions

Accidental Falls

Keywords

AgeingCognitionExecutive FunctionGait

Outcome Measures

Primary Outcomes (1)

  • Cognitive predictor of falls assessed with the Mini-Mental State Examination

    To measure cognitive predictor will be used Mini-Mental State Examination

    falls on past 12 months

Secondary Outcomes (2)

  • Executive function predictor of falls assessed with the Wisconsin Card Sort Test

    falls on past 12 months

  • Gait speed predictor of falls assessed with an accelerometer

    falls on past 12 months

Study Arms (2)

Institutionalized older adults

Observational study

Other: Observational study

Non-institutionalized older adults

Observational study

Other: Observational study

Interventions

Observational studyOTHER

Observational study: kinematic variables, falls and executive function were analyzed

Institutionalized older adultsNon-institutionalized older adults

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty-five individuals living in a long term care facility and twenty-five older adults from community

You may qualify if:

  • People who could walk with or without ambulation devices
  • Mini-Mental State Examination score according to schooling

You may not qualify if:

  • Terminal illnesses
  • Bedridden
  • Unable to see or hear
  • Use of benzodiazepines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • José Carlos Galduróz, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2016

First Posted

March 7, 2016

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 7, 2016

Record last verified: 2016-03