Fall Prevention Among Community Living Elderly

October 11, 2012 updated by: Gunilla Fahlstrom

Fall Prevention by Assistant Nurses Among Community Living Elderly With Risk of Falling - a Randomized Controlled Trial

The purpose of this study is to assess effects of a home exercise program, supervised by assistant nurses with the aim of preventing falls.

Community living persons 65 years of age or older having a risk of falling were invited to participate. Participants were randomized to either training or control.

The training program was individually designed by a physiotherapist and the 5-month program performance was supervised in the partcipants home by eight home visits from an assistant nurse.

All participants received a visit from an occupational therapist who assessed the home and, if necessary, gave advice.

Study Overview

Detailed Description

Falls among elderly are a major public health problem, but preventive interventions containing physical exercise and home improvement are available.

In this study the crucial question was to test whether unlicensed staff, assistant nurses, could be used for preventive work.

Estimation of study power gave that 170 participants in each group would be needed to detect a difference in days with falls, the main outcome measure.

Study Type

Interventional

Enrollment (Actual)

148

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

      • Orebro, Sweden, 701 16
        • Family medicine research center

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 and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • community living persons at least 65 years old
  • independent walking ability with or without walking aid
  • experienced at least one fall during the last 12 months
  • ability to communicate and cooperate with study staff

Exclusion Criteria:

  • ongoing physiotherapy treatment
  • ongoing participation in exercise/acitivity containing balance and strength enhancing components
  • a dementia diagnose
  • mental disorder that affects possibility to communicate and cooperate
  • other medical reason making participation inte the study inappropriate.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training
Complete intervention i.e. basic intervention + individual training program.
The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.
Active Comparator: Control
Basic intervention.
The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days with fall
Time Frame: 12 months
Self reported calendar data
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise
Time Frame: 12 months
Self reported calendar data
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength
Time Frame: Pre and post intervention, 5 months
Chair stand test
Pre and post intervention, 5 months
Balance
Time Frame: Pre and post intervention, 5 months
Falls efficacy scale (FES)
Pre and post intervention, 5 months
Balance
Time Frame: Pre and post intervention, 5 months
Bergs balance scale
Pre and post intervention, 5 months
Walking 3 metres test
Time Frame: Pre and post intervention, 5 months
Pre and post intervention, 5 months
Health related quality of life
Time Frame: Pre and post intervention, 5 months
Self reported interview data, SF-36
Pre and post intervention, 5 months
Activities of daily living
Time Frame: Pre and post intervention, 5 months
ADL
Pre and post intervention, 5 months
Walking
Time Frame: 12 months
Minutes of walking per day, self reported calendar data.
12 months
Hospital days
Time Frame: 12 months
Hospital register data
12 months
Hospital visits
Time Frame: 12 months
Hospital register data
12 months
Fractures or other harms
Time Frame: 12 months
Hospital register data
12 months
Strength
Time Frame: Pre and post assessment, 5 months
Timed Up and Go, TUG
Pre and post assessment, 5 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Gunilla Fahlstrom, PhD, Örebro County Council

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

January 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OLLGF01
  • OLLGF0112 (Other Identifier: Orebro county council)

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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