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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01778972
Other study ID # Fall prevention UV
Secondary ID 307301
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date December 2019

Study information

Verified date April 2019
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 420
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Otago home exercise programme
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.
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.

Locations

Country Name City State
Sweden Homes Uppsala
Sweden Homes Västerås

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Fall-related self-efficacy will be measured with Fall efficacy scale, Swedish version. Two years
Other Grip strength will be measured with Jamar Hand Dynamometer Two years
Other Physical Activity level will be measured with Frändin/Grimby activity scale. Two years
Other Health related quality of life will be measured with European quality of life questionaire (EQ-5D). Two years
Primary Frequence of falls will be measured with a monthly fall-calender 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 Fall-related injuries will be measured by telephone interviews. Two years
Secondary Physical performance will be measured with Short Physical Performance Battery (SPPB) SPPB measures balance, functional leg strength and walking speed. Two years
Secondary Dynamic balance will be assessed with Mini-BESTest 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
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