- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01705912
Fall Prevention Among Community Living Elderly
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Orebro, Sweden, 701 16
- Family medicine research center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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
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Balance
Time Frame: Pre and post intervention, 5 months
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Falls efficacy scale (FES)
|
Pre and post intervention, 5 months
|
Balance
Time Frame: Pre and post intervention, 5 months
|
Bergs balance scale
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Pre and post intervention, 5 months
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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
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Activities of daily living
Time Frame: Pre and post intervention, 5 months
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ADL
|
Pre and post intervention, 5 months
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Walking
Time Frame: 12 months
|
Minutes of walking per day, self reported calendar data.
|
12 months
|
Hospital days
Time Frame: 12 months
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Hospital register data
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12 months
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Hospital visits
Time Frame: 12 months
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Hospital register data
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12 months
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Fractures or other harms
Time Frame: 12 months
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Hospital register data
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12 months
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Strength
Time Frame: Pre and post assessment, 5 months
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Timed Up and Go, TUG
|
Pre and post assessment, 5 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gunilla Fahlstrom, PhD, Örebro County Council
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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