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

Beatrice Pettersson*, Lillemor Lundin-Olsson, Dawn A. Skelton, Per Liv, Magnus Zingmark, Erik Rosendahl, Marlene Sandlund

*Corresponding author for this work

Research output: Contribution to journalArticle

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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 one year in older community-dwelling adults.
Methods and analysis
A two-arm parallel randomized 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 minutes, 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-sec 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 peer-reviewed journals, national and international conferences, and through senior citizens organizations.
Trial registration number
NCT03963570
Original languageEnglish
JournalBMJ Open
Publication statusAccepted/In press - 15 Apr 2020

Keywords

  • Falls prevention
  • Exercise
  • Older people
  • Digital Health
  • self management

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