Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
26 11 2021
Historique:
entrez: 27 11 2021
pubmed: 28 11 2021
medline: 15 12 2021
Statut: epublish

Résumé

Exercise and physical activity (PA) are fundamental to the treatment of type 2 diabetes. Current exercise and PA strategies for newly diagnosed individuals with type 2 diabetes are either clinically effective but unsuitable in routine practice (supervised exercise) or suitable in routine practice but clinically ineffective (PA advice). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and PA advice, enabling patients to engage in regular long-term physically active lifestyles. This feasibility randomised controlled trial (RCT) will evaluate the use of mHealth technology when incorporated into a structured home-based exercise and PA intervention, in those recently diagnosed with type 2 diabetes. This feasibility multicentre, parallel group RCT will recruit 120 individuals with type 2 diabetes (diagnosis within 5-24 months, aged 40-75 years) in the UK (n=60) and Canada (n=60). Participants will undertake a 6-month structured exercise and PA intervention and be supported by an exercise specialist (active control). The intervention group will receive additional support from a smartwatch and phone app, providing real-time feedback and enabling improved communication between the exercise specialist and participant. Primary outcomes are recruitment rate, adherence to exercise and loss to follow-up. Secondary outcomes include a qualitative process evaluation and piloting of potential clinical outcome measures for a future RCT. The trial was approved in the UK by the South East Scotland Research Ethics Committee 01 (20/SS/0101) and in Canada by the Clinical Research Ethics Board of the University of British Columbia (H20-01936), and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings. ISRCTN14335124; ClinicalTrials.gov: NCT04653532.

Identifiants

pubmed: 34836904
pii: bmjopen-2021-052563
doi: 10.1136/bmjopen-2021-052563
pmc: PMC8628337
doi:

Banques de données

ClinicalTrials.gov
['NCT04653532']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e052563

Subventions

Organisme : Medical Research Council
ID : MR/T032189/1
Pays : United Kingdom

Informations de copyright

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

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Auteurs

Katie Hesketh (K)

Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.

Jonathan Low (J)

School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.

Robert Andrews (R)

Exeter Medical School, University of Exeter, Exeter, UK.
Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton, UK.

Charlotte A Jones (CA)

Faculty of Medicine, University of British Columbia, Kelowna, British Columbia, Canada.

Helen Jones (H)

Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.

Mary E Jung (ME)

School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.

Jonathan Little (J)

School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.

Ceu Mateus (C)

Division of Health Research, Lancaster University, Lancaster, UK.

Richard Pulsford (R)

Sport and Health Sciences, University of Exeter, Exeter, UK.

Joel Singer (J)

School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.

Victoria S Sprung (VS)

Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.
Department of Musculoskeletal Biology II, University of Liverpool, Liverpool, UK.

Alison M McManus (AM)

School of Health and Exercise Sciences, University of British Columbia, Kelowna, British Columbia, Canada.

Matthew Cocks (M)

Research Institute for Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK m.s.cocks@ljmu.ac.uk.

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