Fall Prevention Study Among Seniors in Bomlo

January 26, 2021 updated by: Kjersti Helen Folleso

Early Identification and Intervention in Risk of Falling Among Seniors i Bomlo Municipality

Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests performed by physiotherapist. If risk of falling is confirmed, participants will be randomized to either intervention group with fall-preventing exercize program or to a control group. Follow-up over 5 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants randomized to either exercise group or control group. Tests for balance and strength performed by physiotherapist at inclusion, and after three and six months and one year for both groups. Further follow-up and further inclusion of participants had to be terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Bomlo
      • Bremnes, Bomlo, Norway, 5430
        • Bomlo municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 65-85, home-dwellers in Bomlo municipality, capable of following up group-exercize, informed consent.

Exclusion Criteria:

  • Serious illness, in need of walking-aid indoors, moderate to severe cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercize group
10 weeks of physical exercise. Testing of strength and balance.
Behavioral: Physical exercize
10 weeks group exercize followed by community-based voluntary exercize
No Intervention: Control group
Testing of strength and balance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall-related injuries
Time Frame: First year
identified in electronic patient record in primary care
First year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kjersti Helen Folleso

Investigators

  • Study Chair: Kjetil A Gjoesaeter, Bomlo municipality

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

January 25, 2021

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • BK-KS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Accepted for publication in Norwegian scientific journal "Utposten".

IPD Sharing Time Frame

Spring 2021

IPD Sharing Access Criteria

Open access, available in Norwegian

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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