NCT03503916

Brief Summary

Falls are one of the most common reasons for immobilisation and death in elderly population. This study aims at studying falls among a group of older people. The aim is to study the relation between movement patterns, balance performance, inner ear function and future falls. Senior member will be recruited through the non-profit association "Friskis\&Svettis. Measures of movement patterns, balance performance and innear ear function will be measured at baseline. Falls will be monitored through falls diaries, collected every third month during a 12 month period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

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

February 27, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

March 5, 2018

Last Update Submit

October 16, 2018

Conditions

Accidental FallPostural BalanceMovement Disorders in Old Age

Keywords

Accidental fallPostural Balance

Outcome Measures

Primary Outcomes (1)

  • Falls diary

    A falls diary, where accidental falls during the period is noted by the participant

    Measures the occurrence of falls during a 12 month period

Secondary Outcomes (7)

  • The Snubblometer

    At baseline

  • Timed up and Go

    At baseline

  • Timed up and Go manual

    At baseline

  • Timed up and Go cognitive

    At baseline

  • Head shake test

    At baseline

  • +2 more secondary outcomes

Eligibility Criteria

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

Senior members of the non-profit association Friskis\&Svettis in Malmö Sweden, invited at three occasions where workshops about balance was held.

You may qualify if:

  • Men and women, 65 years and older
  • The ability to ability to speak and understand Swedish language.

You may not qualify if:

  • Age younger than 65
  • Not able to speak and understand Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, 22100, Sweden

Location

Study Officials

  • Eva Ekvall Hansson, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

March 5, 2018

First Posted

April 20, 2018

Study Start

February 27, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)