ICT-based system to predict and prevent falls (iStoppFalls): study protocol for an international multicenter randomized controlled trial

[EN] Background: Falls are very common, especially in adults aged 65 years and older. Within the current international European Commission's Seventh Framework Program (FP7) project 'iStoppFalls' an Information and Communication Technology (ICT) based system has been developed to regularly assess a person's risk of falling in their own home and to deliver an individual and tailored home-based exercise and education program for fall prevention. The primary aims of iStoppFalls are to assess the feasibility and acceptability of the intervention program, and its effectiveness to improve balance, muscle strength and quality of life in older people. Methods/Design: This international, multicenter study is designed as a single-blinded, two-group randomized controlled trial. A total of 160 community-dwelling older people aged 65 years and older will be recruited in Germany (n = 60), Spain (n = 40), and Australia (n = 60) between November 2013 and May 2014. Participants in the intervention group will conduct a 16-week exercise program using the iStoppFalls system through their television set at home. Participants are encouraged to exercise for a total duration of 180 minutes per week. The training program consists of a variety of balance and strength exercises in the form of video games using exergame technology. Educational material about a healthy lifestyle will be provided to each participant. Final reassessments will be conducted after 16 weeks. The assessments include physical and cognitive tests as well as questionnaires assessing health, fear of falling, quality of life and psychosocial determinants. Falls will be followed up for six months by monthly falls calendars. Discussion: We hypothesize that the regular use of this newly developed ICT-based system for fall prevention at home is feasible for older people. By using the iStoppFalls sensor-based exercise program, older people are expected to improve in balance and strength outcomes. In addition, the exercise training may have a positive impact on quality of life by reducing the risk of falls. Taken together with expected cognitive improvements, the individual approach of the iStoppFalls program may provide an effective model for fall prevention in older people who prefer to exercise at home.
The authors are members of the iStoppFalls project. This project has received funding from the European Union’s Seventh Framework Programme for research, technological development, and demonstration under grant agreement no [287361]. The Australian arm is funded by an Australian National Health and Medical Research Council (NHMRC) EU collaboration grant (#1038210). The content of the manuscript does not represent the opinion of the European Community or NHMRC. The funding sources have no role in any aspects of this study. Yves J. Gschwind has been financially supported by a research grant from the Margarete and Walter Lichtenstein Foundation, Basel, Switzerland. Stephen R. Lord is supported by NHMRC as a Senior Principal Research Fellow and Kim Delbaere as a NHMRC Career Development Fellow. All other authors are supported by the iStoppFalls project, European Community Grant Agreement 287361. On behalf the iStoppFalls consortium, we would like to thank all the participants who take part in the study.