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  • Long-term effect of smartphone-delivered Interval Walking Training on physical activity in patients with type 2 diabetes: protocol for a parallel group single-blinded randomised controlled trial

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Diabetes and endocrinology
Protocol
Long-term effect of smartphone-delivered Interval Walking Training on physical activity in patients with type 2 diabetes: protocol for a parallel group single-blinded randomised controlled trial
  1. Laura Staun Valentiner1,2,
  2. Mathias Ried-Larsen2,3,4,
  3. Kristian Karstoft2,4,
  4. Cecilie Fau Brinkløv2,4,
  5. Charlotte Brøns2,5,
  6. Rasmus Oestergaard Nielsen1,2,
  7. Robin Christensen6,
  8. Jens Steen Nielsen7,8,
  9. Allan Arthur Vaag2,3,4,
  10. Bente Klarlund Pedersen2,4,
  11. Henning Langberg1,2
  1. 1CopenRehab, Department of Public Health, Section of Social Medicine, Henrik Pontoppidans Vej 6, University of Copenhagen, Copenhagen, Denmark
  2. 2Department of Infectious Diseases, Center for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
  3. 3The Danish Diabetes Academy, Odense University Hospital, Odense, Denmark
  4. 4Department of Infectious Diseases, Centre of Inflammation and Metabolism, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
  5. 5Department of Endocrinology (Diabetes and Metabolism), Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
  6. 6Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
  7. 7Department of Endocrinology, Odense University Hospital, Odense, Denmark
  8. 8OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark
  1. Correspondence to Laura Staun Valentiner; lauravalentiner{at}gmail.com

Abstract

Introduction Physical activity is a cornerstone in type 2 diabetes (T2D) rehabilitation. Effective long-term and low-cost strategies to keep these patients' physically active are needed. However, maintaining physical activity behaviour is difficult once formalised interventions end. Structured exercise training supported by mobile technology and remote feedback is potentially an effective strategy. The objective of the trial is to investigate whether mobile health support using the InterWalk application for smartphones is effective in increasing physical activity levels in persons with T2D over time compared with standard care. We investigate whether Interval Walking Training using the InterWalk application is superior to Danish municipality-based rehabilitation in increasing moderate-and-vigorous physical activity levels in patients with T2D across 52 weeks. Secondary, we hypothesise that a motivational programme added from end of intervention to 52 weeks further increases level of physical activity in everyday life in patients with T2D.

Methods and analysis The trial is a parallel-group, open-labelled, randomised controlled trial with long-term follow-up at 52 week including patients with T2D. The primary outcome is change in moderate-and-vigorous physical activity. The key secondary outcome includes motivation for physical activity behaviour change. Other secondary outcomes are VO2-peak, strength in the lower extremities. Exclusion criterion is medical contraindication to exercise. We include up to 246 patients and randomly allocate them into a control (standard group) or an experimental group (8–12 weeks of IWT supported by the smartphone-based InterWalk application) in a 1:2 fashion. After intervention, the experimental group is randomly allocated into two follow-up conditions with unsupervised IWT with or without motivational support until 52-week follow-up. The intention-to-treat principle is applied.

Ethics and dissemination The local regional Research Ethics Committee in Denmark (H-1-2014-074) and the Danish Data Protection Agency (j.nr. 2014-54-0897) have approved the trial. Positive, negative or inconclusive results will be disseminated in scientific journals and conferences.

Trial registration number NCT02341690.

  • Type 2 diabetes
  • Rehabilitation
  • Interval Walking Training
  • Physical Activity
  • Behaviour maintenance

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-014036

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    Footnotes

    • Collaborators The Municipality of Copenhagen is a collaborator in the trial. The Municipality of Guldborgsund is a collaborator in the trial. Bornholm Hospital is a collaborator in the trial. Assigned Health professionals working in the Municipality of Copenhagen, The Municipality of Guldborgsund and at Bornholm Hospital all contributed to the trial, by recruiting, testing and training with participating patients in the trial.

    • Contributors LSV, MR-L and HL drafted the manuscript. All authors made substantial contributions to conception and design, and revised the manuscripts critically for important intellectual content. All authors have given their approval for the manuscript to be published.

    • Funding The work has been supported by two grants by the Tryg Foundation, Denmark. The Centre for Physical Activity Research (CFAS) is supported by a grant from TrygFonden. The study was further supported by grants from. The Augustinus Foundation and two foundations in the Capital Region of Denmark—the Foundation for Prevention and the Foundation for Intersectorial Research Projects have also supported the work. LSV is supported by a grant from the Municipality of Copenhagen, Denmark and The Danish Physiotherapist Foundation. MR-L is supported by a postdoctoral grant from the Danish Diabetes Academy supported by the Novo Nordisk Foundation and The Vissing Foundation. CIM/CFAS is a member of DD2—the Danish Center for Strategic Research in Type 2 Diabetes (the Danish Council for Strategic Research, grant numbers 09-067009 and 09-075724). RC is supported by grants from The Oak Foundation. HL is supported by a professor grant from the Municipality of Copenhagen, Denmark.

    • Competing interests None declared.

    • Ethics approval The local regional Research Ethics Committee in Denmark (H-1-2014-074) and the Danish Data Protection Agency (j.nr. 2014-54-0897) has approved the trial.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Remaining study material not designated to planned articles (specified in the protocol article) is available by contacting the corresponding author (LSV). If relevant, a proposal can be made to the InterWalk steering committee. If approved, data are available.