Fall Prevention Among Community Living Elderly

NCT ID: NCT01705912

Last Updated: 2012-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Accidental Falls/Prevention and Control

Keywords

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fall prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Training

Complete intervention i.e. basic intervention + individual training program.

Group Type EXPERIMENTAL

Complete intervention

Intervention Type OTHER

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.

Control

Basic intervention.

Group Type ACTIVE_COMPARATOR

Basic intervention

Intervention Type OTHER

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.

Interventions

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Complete intervention

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro County Council

OTHER_GOV

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role collaborator

Gunilla Fahlstrom

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gunilla Fahlstrom

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gunilla Fahlstrom, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro County Council

Locations

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Family medicine research center

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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OLLGF0112

Identifier Type: OTHER

Identifier Source: secondary_id

OLLGF01

Identifier Type: -

Identifier Source: org_study_id