Clinical trial NCT02374307: Falls Prevention in Older Home Care Recipients
Official title: Effect of a Falls-prevention Exercise Program on Health-related Quality of Life in Older Fallers Receiving Home Care. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Falls
Home care
Older people
Falls prevention
Quality of life
Exercise
Balance
Preventative care
Community health services
Home-help services
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 155
Sex: ALL
Minimum age (years): 67
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to investigate the effect of a falls-prevention exercise programme on health-related quality of life, fear of falling, falls and physical function in older people receiving home care. Participants in the intervention group perform the Otago exercise programme. Participants in the control group continue their usual activities.

Detailed description: Falls and falls-related injuries are considered a serious public health issue in the older population. Strength and balance exercise in combination with information about falls prevention seems to be effective in reducing falls, but less is known about the effect of this kind of intervention on quality of life. This randomized controlled trial investigates the effect of a falls prevention program on health-related quality of life, fear of falling, falls and physical function in community-dwelling older people who receive home care.

Eligibility criteria: Inclusion Criteria:

* has fallen at least one time in the last 12 months
* receives home-help services
* able to walk independently indoors with or without walking aid

Exclusion Criteria:

* medical contraindication to exercise
* life expectancy \<1 year
* scores under 23 points on Mini Mental Scale Examination
* participating in another falls prevention programme during the 12 weeks of the programme, for example a falls prevention group

Primary outcomes:
measure: Short Form 36 Health Survey Summary Scores
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: EQ-5D
timeFrame: Baseline, 3 months, 6 months
measure: Berg Balance Scale
timeFrame: Baseline, 3 months, 6 months
measure: Sit-to-stand Test
timeFrame: Baseline, 3 months, 6 months
measure: 4-meter Walk Test
timeFrame: Baseline, 3 months, 6 months
measure: Falls Efficacy Scale - International
timeFrame: Baseline, 3 months, 6 months
measure: Instrumental Activities of Daily Living
timeFrame: Baseline, 3-months, 6-months
measure: Walking Habits
timeFrame: Baseline, 3 months, 6 months
measure: Mini Nutritional Assessment
timeFrame: Baseline, 3 months, 6 months
measure: Exercise According to the Protocol. Adherence
timeFrame: Baseline and 3 months
measure: No. of Participants Exercising Post-intervention
timeFrame: 3 months and 6 months
measure: No. of Falls
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Drøbak
country: Norway
facility: Municipality of Frogn
state: Akershus
city: Fjerdingby
country: Norway
facility: Municipality of Rælingen
state: Akershus
city: Lillestrøm
country: Norway
facility: Municipality of Skedsmo
state: Akershus
city: Lørenskog
country: Norway
facility: Municipality of Lørenskog
state: Akershus
city: Sandvika
country: Norway
facility: Municipality of Bærum
state: Akershus
city: Sørumsand
country: Norway
facility: Municipality of Sørum
state: Akershus
Study officials:
affiliation: OsloMet - Oslo Metropolitan University
name: Astrid Bergland, PhD
role: STUDY_DIRECTOR
affiliation: OsloMet - Oslo Metropolitan University
name: Maria Bjerk, MSc
role: PRINCIPAL_INVESTIGATOR
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citation: Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.
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citation: Bjerk M, Brovold T, Skelton DA, Bergland A. A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial. BMC Health Serv Res. 2017 Aug 14;17(1):559. doi: 10.1186/s12913-017-2516-5.
citation: Bjerk M, Brovold T, Skelton DA, Bergland A. Associations between health-related quality of life, physical function and fear of falling in older fallers receiving home care. BMC Geriatr. 2018 Oct 22;18(1):253. doi: 10.1186/s12877-018-0945-6.
citation: Bjerk M, Brovold T, Skelton DA, Liu-Ambrose T, Bergland A. Effects of a falls prevention exercise programme on health-related quality of life in older home care recipients: a randomised controlled trial. Age Ageing. 2019 Mar 1;48(2):213-219. doi: 10.1093/ageing/afy192.
citation: Bjerk M, Brovold T, Davis JC, Skelton DA, Bergland A. Health-related quality of life in home care recipients after a falls prevention intervention: a 6-month follow-up. Eur J Public Health. 2020 Feb 1;30(1):64-69. doi: 10.1093/eurpub/ckz106.
citation: Bjerk M, Brovold T, Davis JC, Bergland A. Evaluating a falls prevention intervention in older home care recipients: a comparison of SF-6D and EQ-5D. Qual Life Res. 2019 Dec;28(12):3187-3195. doi: 10.1007/s11136-019-02258-x. Epub 2019 Jul 30.