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Digital technology to deliver a lifestyle-integrated exercise intervention in young seniors -- the PreventIT feasibility randomized controlled trial
Taraldsen K, Mikolaizak AS, Maier AB, Mellone S, Boulton E, Aminian K, Becker C, Chiari L, Follestad T, Gannon B, Paraschiv-Ionescu A, Pijnappels M, Saltvedt I, Schwenk M, Todd C, Yang FB, Zacchi A, van Ancum J, Vereijken B, Helbostad JL
Frontiers in Digital Health 2020 Jul 31;2(10):Epub
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Behavioral change is the key to alter individuals' lifestyle from sedentary to active. The aim was to assess the feasibility of delivering a Lifestyle-integrated Functional Exercise programme and evaluate the delivery of the intervention by use of digital technology (eLiFE) to prevent functional decline in 61 to 70 year-old adults. METHODS: This multicentre, feasibility randomized controlled trial was run in three countries (Norway, Germany, and the Netherlands). Out of 7,500 potential participants, 926 seniors (12%) were screened and 180 participants randomized to eLiFE (n = 61), aLiFE (n = 59), and control group (n = 60). eLiFE participants used an application on smartphones and smartwatches while aLiFE participants used traditional paper-based versions of the same lifestyle-integrated exercise intervention. Participants were followed for 12 months, with assessments at baseline, after a 6 month active trainer-supported intervention, and after a further 6 months of unsupervised continuation of the programme. RESULTS: At 6 months, 87% of participants completed post-test, and 77% completed the final assessment at 12 months. Participants were willing to be part of the programme, with compliance and reported adherence relatively high. Despite small errors during start-up in the technological component, intervention delivery by use of technology appeared acceptable. No serious adverse events were related to the interventions. All groups improved regarding clinical outcomes over time, and complexity metrics show potential as outcome measure in young seniors. CONCLUSION: This feasibility RCT provides evidence that an ICT-based lifestyle-integrated exercise intervention, focusing on behavioral change, is feasible and safe for young seniors. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03065088. Registered on 14 February 2017.

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