Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial

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Abstract

Introduction

Exercise interventions have a strong evidence base for falls prevention. However, exercise can be challenging to implement and often has limited reach and poor adherence. Digital technology provides opportunities for both increased access to the intervention and support over time. Further knowledge needs to be gained regarding the effectiveness of completely self-managed digital exercise interventions. The main objective of this study is to compare the effectiveness of a self-managed digital exercise programme, Safe Step, in combination with monthly educational videos with educational videos alone, on falls over 1 year in older community-dwelling adults.

Methods and analysis

A two-arm parallel randomised controlled trial will be conducted with at least 1400 community-living older adults (70+ years) who experience impaired balance. Participants will be recruited throughout Sweden with enrolment through the project website. They will be randomly allocated to either the Safe Step exercise programme with additional monthly educational videos about healthy ageing and fall prevention, or the monthly education videos alone. Participants receiving the exercise intervention will be asked to exercise at home for at least 30 min, 3 times/week with support of the Safe Step application. The primary outcome will be rate of falls (fall per person year). Participants will keep a fall calendar and report falls at the end of each month through a digital questionnaire. Further assessments of secondary outcomes will be made through self-reported questionnaires and a self-test of 30 s chair stand test at baseline and 3, 6, 9 and 12 months after study start. Data will be analysed according to the intention-to-treat principle.

Ethics and dissemination

Ethical approval was obtained by The Regional Ethical Review Board in Umeå (Dnr 2018/433-31). Findings will be disseminated through the project web-site, peer-reviewed journals, national and international conferences and through senior citizen organisations’ newsletters.

Trial registration number

NCT03963570.

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Most cited references 33

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Risk factors for falls among elderly persons living in the community.

Mary E. Tinetti, Mark Speechley, Sandra F. Ginter (1988)

To study risk factors for falling, we conducted a one-year prospective investigation, using a sample of 336 persons at least 75 years of age who were living in the community. All subjects underwent detailed clinical evaluation, including standardized measures of mental status, strength, reflexes, balance, and gait; in addition, we inspected their homes for environmental hazards. Falls and their circumstances were identified during bimonthly telephone calls. During one year of follow-up, 108 subjects (32 percent) fell at least once; 24 percent of those who fell had serious injuries and 6 percent had fractures. Predisposing factors for falls were identified in linear-logistic models. The adjusted odds ratio for sedative use was 28.3; for cognitive impairment, 5.0; for disability of the lower extremities, 3.8; for palmomental reflex, 3.0; for abnormalities of balance and gait, 1.9; and for foot problems, 1.8; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables. The risk of falling increased linearly with the number of risk factors, from 8 percent with none to 78 percent with four or more risk factors (P less than 0.0001). About 10 percent of the falls occurred during acute illness, 5 percent during hazardous activity, and 44 percent in the presence of environmental hazards. We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling.

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Development and initial validation of the Falls Efficacy Scale-International (FES-I).

Lucy Yardley, Nina Beyer, Klaus Hauer … (2005)

There is a need for a measure of fear of falling that assesses both easy and difficult physical activities and social activities and is suitable for use in a range of languages and cultural contexts, permitting direct comparison between studies and populations in different countries and settings. To develop a modified version of the Falls Efficacy Scale to satisfy this need, and to establish its psychometric properties, reliability, and concurrent validity (i.e. that it demonstrates the expected relationship with age, falls history and falls risk factors). Cross-sectional survey. Community sample. 704 people aged between 60 and 95 years completed The Falls Efficacy Scale-International (FES-I) either in postal self-completion format or by structured interview. The FES-I had excellent internal and test-retest reliability (Cronbach's alpha=0.96, ICC=0.96). Factor analysis suggested a unitary underlying factor, with two dimensions assessing concern about less demanding physical activities mainly in the home, and concern about more demanding physical activities mainly outside the home. The FES-I had slightly better power than the original FES items to discriminate differences in concern about falling between groups differentiated by sex, age, occupation, falls in the past year, and falls risk factors (chronic illness, taking multiple or psychoactive medications, dizziness). The FES-I has close continuity with the best existing measure of fear of falling, excellent psychometric properties, and assesses concerns relating to basic and more demanding activities, both physical and social. Further research is required to confirm cross-cultural and predictive validity.

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Risk factors for falls in a community-based prospective study of people 70 years and older.

A. Campbell, M. J. Borrie, G. Spears (1989)

We investigated factors associated with falls in a community-based prospective study of 761 subjects 70 years and older. The group experienced 507 falls during the year of monitoring. On entry to the study a number of variables had been assessed in each subject. Variables associated with an increased risk of falling differed in men and women. In men, decreased levels of physical activity, stroke, arthritis of the knees, impairment of gait, and increased body sway were associated with an increased risk of falls. In women, the total number of drugs, psychotropic drugs and drugs liable to cause postural hypotension, standing systolic blood pressure of less than 110 mmHg, and evidence of muscle weakness were also associated with an increased risk of falling. Most falls in elderly people are associated with multiple risk factors, many of which are potentially remediable. The possible implications of this in diagnosis and prevention are discussed.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2020

Publication date (Electronic): 17 May 2020

Volume: 10

Issue: 5

Electronic Location Identifier: e036194

Affiliations

[1 ]departmentDepartment of Community Medicine and Rehabilitation, Physiotherapy , Umeå University , Umeå, Sweden

[2 ]departmentSchool of Health and Life Sciences , Glasgow Caledonian University , Glasgow, UK

[3 ]departmentDepartment of Public Health and Clinical Medicine, Section of Sustainable Health , Umeå University , Umeå, Sweden

[4 ]departmentHealth and Social Care Administration , Municipality of Östersund , Östersund, Sweden

[5 ]departmentDepartment of Epidemiology and Global Health , Umeå University , Umeå, Sweden

Author notes

[Correspondence to ] Beatrice Pettersson; beatrice.pettersson@ 123456umu.se

Author information

Beatrice Pettersson http://orcid.org/0000-0002-5147-9715

Article

Publisher ID: bmjopen-2019-036194

DOI: 10.1136/bmjopen-2019-036194

PMC ID: 7239551

PubMed ID: 32423936

SO-VID: e99f3065-de08-4f6c-ae48-bfcc6e2b1a88

License:

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

History

Date received : 04 December 2019

Date revision received : 14 April 2020

Date accepted : 15 April 2020

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ScienceOpen disciplines: Medicine

Keywords: preventive medicine,statistics & research methods,public health,geriatric medicine

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ScienceOpen disciplines: Medicine

Keywords: preventive medicine, statistics & research methods, public health, geriatric medicine

Effectiveness of a self-managed digital exercise programme to prevent falls in older community-dwelling adults: study protocol for the Safe Step randomised controlled trial

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

China Tropical Medicine

Most cited references 33

Risk factors for falls among elderly persons living in the community.

Development and initial validation of the Falls Efficacy Scale-International (FES-I).

Risk factors for falls in a community-based prospective study of people 70 years and older.

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Affiliations

Author notes

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