NCT02995317

Brief Summary

The purpose of this study is to investigate if the level of physical activity, selected physical and psychological risk factors can predict risk of falling in older (≥65) community dwellers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

December 13, 2016

Last Update Submit

April 14, 2020

Conditions

Keywords

AgedGaitPostural BalanceAccelerometryPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Self-reported number of falls confirmed by monthly phone calls

    One year follow-up

Study Arms (1)

Fall accidents

Other: Number of falls based on an one year follow-up

Interventions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be undertaken in Aalborg Municipality at different activity-centers and nursing homes in collaboration with care workers, nurses and staff at the activity centers, all employed at the Department of Elderly and Health. Furthermore the project manager arranges briefing meetings with groups of employees in order to provide clarification of the project and encourage support of the recruitment of the study-population. Participants satisfying the inclusion and exclusion criteria is contacted by the project group, to ensure that they fully understand what it takes to participate. Subsequently, an appointment for completion of the baseline data is made.

You may qualify if:

  • Home dwelling
  • Manage body transfer independently
  • Walking ability for at least 10 meters with or without assistive devices

You may not qualify if:

  • Progressive neurological or rheumatologically illness
  • Diagnosed vestibular problems
  • Experienced pain in a substantial degree, limiting or obstructing everyday living
  • Known uncorrected visual or hearing problems.
  • Serious difficulties in speaking, understanding or reading Danish.
  • Cognitive impairment equivalent to Mini Mental State Examination \< 23

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College of Northern Denmark

Aalborg, 9220, Denmark

RECRUITING

Related Publications (1)

  • Villumsen M, Grarup B, Christensen SWMP, Palsson TS, Hirata RP. "Study protocol for the >/=65 years NOrthern jutland Cohort of Fall risk Assessment with Objective measurements (the NOCfao study)". BMC Geriatr. 2020 Jun 8;20(1):198. doi: 10.1186/s12877-020-01535-6.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bo Grarup

    University College of Northern Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Grarup

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 16, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations