Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults

Kristin Taraldsen, A Stefanie Mikolaizak, Andrea B Maier, Elisabeth Boulton, Kamiar Aminian, Jeanine van Ancum, Stefania Bandinelli, Clemens Becker, Ronny Bergquist, Lorenzo Chiari, Lindy Clemson, David P French, Brenda Gannon, Helen Hawley-Hague, Nini H Jonkman, Sabato Mellone, Anisoara Paraschiv-Ionescu, Mirjam Pijnappels, Michael Schwenk, Chris Todd, Fan Bella Yang, Anna Zacchi, Jorunn L Helbostad, Beatrix Vereijken, Kristin Taraldsen, A Stefanie Mikolaizak, Andrea B Maier, Elisabeth Boulton, Kamiar Aminian, Jeanine van Ancum, Stefania Bandinelli, Clemens Becker, Ronny Bergquist, Lorenzo Chiari, Lindy Clemson, David P French, Brenda Gannon, Helen Hawley-Hague, Nini H Jonkman, Sabato Mellone, Anisoara Paraschiv-Ionescu, Mirjam Pijnappels, Michael Schwenk, Chris Todd, Fan Bella Yang, Anna Zacchi, Jorunn L Helbostad, Beatrix Vereijken

Abstract

Introduction: The European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE).

Methods and analysis: The PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm).

Ethics and dissemination: Ethical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published.

Trial registration number: NCT03065088; Pre-results.

Keywords: balance; behaviour change; functional decline; mobile health units; muscle strength; physical activity.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The architecture of the enhanced LiFE (eLiFE) system. Physical behaviour is continuously monitored by a smartphone and a smartwatch, connected through a Bluetooth. The same units are also used for delivering the intervention. Data are calculated and stored locally on the smartphone and then sent to a cloud-based server for further processing and storing. The collected information is sent back to the smartphones in the form of motivational messages and feedback on behaviour.
Figure 2
Figure 2
PreventIT flow diagram. aLiFE, adapted LiFE; eLiFE, enhanced LiFE.

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