Falls Prevention in Older Home Care Recipients

Accidental Falls Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374307
• Other study ID #: 130140
• Secondary ID: 2014/2051
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: November 2019
• Source: Oslo and Akershus University College of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 67 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Other:
• Exercise and education
Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.

Locations

Country	Name	City	State
Norway	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

Sponsors (1)

Lead Sponsor	Collaborator
Oslo and Akershus University College of Applied Sciences

Country where clinical trial is conducted

Norway, 

References & Publications (16)

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 Jul 30. doi: 10.1007/s11136-019-02258-x. [Epub ahead of print] — View 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. 2019 Jun 6. pii: ckz106. doi: 10.1093/eurpub/ckz106. [Epub ahead — View 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. — View 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. — View 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/ — View Citation

Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. Review. — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

Guralnik 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. — View Citation

Herdman 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. — View Citation

Janssen 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. — View Citation

Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. — View Citation

Muir 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. — View 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. Review. — View Citation

Vellas 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. Review. — View Citation

Ware 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. — View Citation

Yardley 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	EQ-5D	Changes in the EuroQOL EQ-5D instrument indicating changes in health-related quality of life. Preference weights for United Kingdom were employed to generate utility scores ranging from -0.59 to 1. A score of 1 is associated with a health state without problems. A positive change in EQ-5D indicates a better health-related quality of life.	Baseline, 3 months, 6 months
Secondary	Berg Balance Scale	Changes in the Berg Balance Scale (BBS), a 14-item scale applied to assess static and dynamic balance in older adults. The summary score ranges from 0 (low, wheelchair bound) to 56 (high, independent)	Baseline, 3 months, 6 months
Secondary	Sit-to-stand Test	Changes in the no. of raises in 30 seconds. From the sitting position, the subject stands completely up, then sits completely back down, repeated for 30 seconds.	Baseline, 3 months, 6 months
Secondary	4-meter Walk Test	Changes in the 4-meter walk test. Participants are asked to walk a distance of 4 meters at their usual pace, measured in m/s	Baseline, 3 months, 6 months
Secondary	Falls Efficacy Scale - International	Changes in falls-efficacy measured with the Falls Efficacy Scale - International (FES-I) derives from a self-report questionnaire, assessing concerns about falling in 16 different daily activities. The total score ranges from 16 (no concern) to 64 (high concern). A decrease in scores indicates less concerns.	Baseline, 3 months, 6 months
Secondary	Instrumental Activities of Daily Living	No. of participants with scores on the Instrumental Activities of Daily Living (IADL) scale, Lawton and Brody. IADL is a measure of a person's self-reported ability to perform complex activities of daily living. The summary score ranges from 0 (low function, dependent) to 8 (high function, independent).	Baseline, 3-months, 6-months
Secondary	Walking Habits	Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.	Baseline, 3 months, 6 months
Secondary	Mini Nutritional Assessment	The summary score of the Mini Nutritional Assessment (MNA) maps to three nutritional statuses "Normal nutritional status", "Risk of malnutrition" and being "Malnourished".	Baseline, 3 months, 6 months
Secondary	Exercise According to the Protocol. Adherence	No. of participants in the intervention group performing exercises according to the protocol in the intervention period until 3-months follow-up. Participant are encouraged to complete an activity diary where they note if the exercise programme has been executed as planned. If they have not completed sufficient exercises, they are supposed to make a note in the diary.	Baseline and 3 months
Secondary	No. of Participants Exercising Post-intervention	Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up.	3 months and 6 months
Secondary	No. of Falls	No. of falls in the post-intervention period between 3-months follow-up and 6-months follow-up. Falls are defined as an event, i.e. fall, trip, slip, which results in the person coming to rest on the ground or floor or other lower level.	3 months and 6 months