Falls Prevention in Older Home Care Recipients
Effect of a Falls-prevention Exercise Program on Health-related Quality of Life in Older Fallers Receiving Home Care. A Randomized Controlled Trial
2 other identifiers
interventional
155
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
November 14, 2019
CompletedNovember 14, 2019
November 1, 2019
1.6 years
February 16, 2015
November 23, 2018
November 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short Form 36 Health Survey Summary Scores
Changes in the Short Form 36 Health Survey (SF-36) summary scores from baseline to 3-months follow-up. SF-36 measures health-related quality of life. Its summary score is comprised of a physical component summary (PCS) and a mental component summary (MCS). The scores range from 0-100 (worst-best) in each scale. A positive change in the summary score indicates a better health-related quality of life.
Baseline, 3 months, 6 months
Secondary Outcomes (11)
EQ-5D
Baseline, 3 months, 6 months
Berg Balance Scale
Baseline, 3 months, 6 months
Sit-to-stand Test
Baseline, 3 months, 6 months
4-meter Walk Test
Baseline, 3 months, 6 months
Falls Efficacy Scale - International
Baseline, 3 months, 6 months
- +6 more secondary outcomes
Study Arms (2)
Exercise and education
EXPERIMENTALThis group performs a 12-week individual tailored home exercise programme in accordance with the manual of Otago exercise programme. Physiotherapists visit the participants 5 times during the 12 weeks (at week 1,2,4,8 and 10) to prescribe and progress exercises. Motivational conversations on telephone are performed the weeks when no visits are scheduled. Additionally, the participants receive information on the first visit which will focus on motivation, importance of adherence and effectiveness of falls prevention. The participants are expected to do exercises on their own, and in that way perform exercises 3 times weekly. If safe, the participant are provided with a walking plan and be encouraged to walk twice weekly.
Control
NO INTERVENTIONThe control group performs activities as usual.
Interventions
Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Municipality of Frogn
Drøbak, Akershus, Norway
Municipality of Rælingen
Fjerdingby, Akershus, Norway
Municipality of Skedsmo
Lillestrøm, Akershus, Norway
Municipality of Lørenskog
Lørenskog, Akershus, Norway
Municipality of Bærum
Sandvika, Akershus, Norway
Municipality of Sørum
Sørumsand, Akershus, Norway
Related Publications (16)
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PMID: 10109801BACKGROUNDBrooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
PMID: 10158943BACKGROUNDHerdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
PMID: 21479777BACKGROUNDJanssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013 Sep;22(7):1717-27. doi: 10.1007/s11136-012-0322-4. Epub 2012 Nov 25.
PMID: 23184421BACKGROUNDWare JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PMID: 1593914BACKGROUNDYardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
PMID: 16267188BACKGROUNDGuralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.
PMID: 8126356BACKGROUNDLawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PMID: 5349366BACKGROUNDVellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
PMID: 9990575BACKGROUNDThomas 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.
PMID: 20817938BACKGROUNDMuir SW, Berg K, Chesworth B, Speechley M. Use of the Berg Balance Scale for predicting multiple falls in community-dwelling elderly people: a prospective study. Phys Ther. 2008 Apr;88(4):449-59. doi: 10.2522/ptj.20070251. Epub 2008 Jan 24.
PMID: 18218822BACKGROUNDBjerk 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.
PMID: 28806904RESULTBjerk 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.
PMID: 30348098RESULTBjerk 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.
PMID: 30615055RESULTBjerk 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.
PMID: 31169888RESULTBjerk 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.
PMID: 31364036RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Some measurements are self-reported.
Results Point of Contact
- Title
- Maria Bjerk
- Organization
- OsloMet - Oslo Metropolitan University
Study Officials
- STUDY DIRECTOR
Astrid Bergland, PhD
OsloMet - Oslo Metropolitan University
- PRINCIPAL INVESTIGATOR
Maria Bjerk, MSc
OsloMet - Oslo Metropolitan University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Research Fellow
Study Record Dates
First Submitted
February 16, 2015
First Posted
February 27, 2015
Study Start
February 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
November 14, 2019
Results First Posted
November 14, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share
The raw data collected in this project is only available to the participating researchers due to risk to confidentiality of participants and Norwegian data protection laws. An anonymized subset of the raw data, where direct and potentially indirect person identifiers are removed, is planned to be made available in a public data repository after the project is finished and main results are published.