Fall Prevention for Old Community-dwelling People

September 28, 2021 updated by: karin hellstrom, Uppsala University

Fall Prevention for Old Community-dwelling People in Uppsala, Västerås and Sörmland

Fall-related injuries are a major health problem in the growing older population. Most older people are not aware of that physical training can decrease the risk of falling. The aim of tha study is to investigate the effect of the Otago home exercise programme with and without motivational interviewing in community-dwelling people 75 years or older on frequence of falls, fall-related injuries, physical capacity, fall-related self-efficacy, quality of life, mortality and health-related costs.

Study Overview

Detailed Description

Participants in the two intervention groups will exercise at home with supervision from physiotherapist week one, two, four and eight. They will then be contacted for telephone follow-up month five, seven and twelve after the start of training. The control group is encouraged to live as usual.

All participants are assessed at baseline, after three, 12 and 24 months from inclusion in the study.

Study Type

Interventional

Enrollment (Anticipated)

420

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

      • Uppsala, Sweden
        • Homes
      • Västerås, Sweden
        • Homes

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

75 years or older, community-dwelling, in need of homecare or rollator

Exclusion Criteria:

Cognitive impairment (below 25 on Mini Mental test) Not able to transfer independently indoors -

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Otago home training programme

Otago home exercise programme was designed specifically to prevent fall. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan.

The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist.

Otago home exercise program was designed specifically to prevent falls. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan.

The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist.

Experimental: Motivational interviewing plus Otago
This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.
This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.
No Intervention: Control grop
Participants are instructed to live their ordinary lives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequence of falls will be measured with a monthly fall-calender
Time Frame: Two year
A fall-calender with registration of falls on a monthly bases will be used to record falls. The fall-calender should be sent in each month. Falls will be followed-up with telephone interviews.
Two year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall-related injuries will be measured by telephone interviews.
Time Frame: Two years
Two years
Physical performance will be measured with Short Physical Performance Battery (SPPB)
Time Frame: Two years
SPPB measures balance, functional leg strength and walking speed.
Two years
Dynamic balance will be assessed with Mini-BESTest
Time Frame: Two years
Mini-BESTest assess dynamic balance impairments in 14 items. The items covers a broad spectrum of performance tasks, including transitions and anticipatory postural adjustments, postural responses to to perturbation, sensory orientation and dynamic stability in gait.
Two years

Other Outcome Measures

Outcome Measure
Time Frame
Fall-related self-efficacy will be measured with Fall efficacy scale, Swedish version.
Time Frame: Two years
Two years
Grip strength will be measured with Jamar Hand Dynamometer
Time Frame: Two years
Two years
Physical Activity level will be measured with Frändin/Grimby activity scale.
Time Frame: Two years
Two years
Health related quality of life will be measured with European quality of life questionaire (EQ-5D).
Time Frame: Two years
Two years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Karin E Hellström, PhD, Uppsala University
  • Principal Investigator: Ann-Christin Johansson, PhD, Mälardalens University, Sweden
  • Principal Investigator: Anne Söderlund, Professor, Mälardalens University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

November 1, 2012

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Fall prevention UV
  • 307301 (Other Grant/Funding Number: Regional forskningsrådet i Uppsala- och Örebroregionen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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