- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778972
Fall Prevention for Old Community-dwelling People
Fall Prevention for Old Community-dwelling People in Uppsala, Västerås and Sörmland
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Uppsala, Sweden
- Homes
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Västerås, Sweden
- Homes
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
|
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No Intervention: Control grop
Participants are instructed to live their ordinary lives.
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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.
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Two year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall-related injuries will be measured by telephone interviews.
Time Frame: Two years
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Two years
|
|
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Physical performance will be measured with Short Physical Performance Battery (SPPB)
Time Frame: Two years
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SPPB measures balance, functional leg strength and walking speed.
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Two years
|
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Dynamic balance will be assessed with Mini-BESTest
Time Frame: Two years
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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
|
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Grip strength will be measured with Jamar Hand Dynamometer
Time Frame: Two years
|
Two years
|
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Physical Activity level will be measured with Frändin/Grimby activity scale.
Time Frame: Two years
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Two years
|
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Health related quality of life will be measured with European quality of life questionaire (EQ-5D).
Time Frame: Two years
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Two years
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Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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