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 ToddFan Bella Yang, Anna Zacchi, Jorunn L. Helbostad, Beatrix Vereijken

*Corresponding author for this work

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Article numbere023526
Pages (from-to)1-20
Number of pages20
JournalBMJ Open
Volume9
Issue number3
Early online date20 Mar 2019
DOIs
Publication statusPublished - 20 Mar 2019

Funding

The trial commenced recruitment in March 2017. In August 2017, a total of 180 participants were included in the trial. We thank the ongoing support of participants, research staff, coordinators, data managers and other site staff who have been responsible for setting up the trial, recruiting participants and collecting data. Contributors All authors made substantial contribution to the concept and design of the study. KT drafted the manuscript, with input from BV and JLH. EB, DPF, CT and HHH provided input on behavioural change. SM, AZ, KA and API provided technical input on the eLiFE description. FBY and BG provided input on health economics. CB, MS and LC provided input on the background information about the project. ABM, JvA, NHJ and MP provided input on the medical assessment and screening of participants. SB, RB, BV, JLH and LC commented on the entire manuscript. KT, ASM, BV and JLH critically revised the manuscript with input from all coauthors. All authors approved the final version of the document. Funding The feasibility RCT is part of the EU funded project ’PreventIT' (2016– 2018, grant number 689238) responding to the Horizon 2020, Personalised Health and Care call PHC-21: Advancing active and healthy aging with ICT: Early risk detection and intervention. The PreventIT project focuses on a new behaviour change activity approach for young older adults (61–70 years of age) with an overall aim to shift focus from treatment of conditions and diseases to early prevention and to empower people to take care of their own health. Disclaimer The EU was not actively responsible or involved in the study design, collection, management, analysis or interpretation of data. The writing of reports and the decision to submit for publication is not authorised by the EU. Competing interests None declared. Ethics approval The study and methods were evaluated and approved by the ethical committees in Norway (REK midt, 2016/1891), Stuttgart (registration number 770/2016BO1), and Amsterdam (METc VUmc registration number 2016.539 (NL59977.029.16)). Provenance and peer review Not commissioned; externally peer reviewed.

FundersFunder number
Horizon 2020 Framework Programme689238

    Keywords

    • balance
    • behaviour change
    • functional decline
    • mobile health units
    • muscle strength
    • physical activity

    Fingerprint

    Dive into the research topics of 'Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults'. Together they form a unique fingerprint.

    Cite this