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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03503916
Other study ID # 2017/56
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 27, 2017
Est. completion date August 31, 2018

Study information

Verified date October 2018
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Falls are one of the most common reasons for immobilisation and death in elderly population. They will be even more essential to address when large birth cohorts grow older and life expectancy increases. Number of elderly persons is constantly rising. When in 2010 there was 1730 000 over 65-year olds in Sweden, the prognosis for year 2060 is 3221 000 persons. Hence, it is important to find solutions for preventing falls. The aim of this project is to study the relation between movement patterns, balance performance, inner ear function and future falls. After measuring movement patterns, inner ear function and balance at baseline, falls will be monitored through falls diaries, collected every third month during a twelve month period in a group of older persons, recruited through the non-profit association "Friskis&Svettis" in Malmö, Sweden. The study population will consist of senior members in the association, invited to workshops about balance.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Men and women, 65 years and older

- The ability to ability to speak and understand Swedish language.

Exclusion Criteria:

- Age younger than 65

- Not able to speak and understand Swedish language

Study Design


Locations

Country Name City State
Sweden Lund University Lund

Sponsors (1)

Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The Snubblometer A wearable device attached to the persons thigh, measures movement patterns At baseline
Secondary Timed up and Go Sitting on a chair, rise up, walk for 3 meter, turn and go back again At baseline
Secondary Timed up and Go manual Sitting on a chair, rise up, walk for 3 meter, turn and go back again while carrying a cup of water At baseline
Secondary Timed up and Go cognitive Sitting on a chair, rise up, walk for 3 meter, turn and go back again while counting down from 100 by 3 At baseline
Secondary Head shake test Test of inner ear function by shaking the head for 15 seconds and wearing frenzels At baseline
Secondary Dix-Hallpike tess Wearing frenzels, and testing for BPPV At baseline
Secondary Head impulse test Testing of inner-ear function while wearing frenzels At baseline
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