PMID- 37072802 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230421 IS - 2055-5784 (Print) IS - 2055-5784 (Electronic) IS - 2055-5784 (Linking) VI - 9 IP - 1 DP - 2023 Apr 18 TI - Electrically assisted cycling for individuals with type 2 diabetes mellitus: a pilot randomized controlled trial. PG - 60 LID - 10.1186/s40814-023-01283-5 [doi] LID - 60 AB - BACKGROUND: Type 2 diabetes mellitus (T2DM) and its associated complications puts considerable strain on healthcare systems. With the global incidence of T2DM increasing, effective disease management is essential. Physical activity (PA) is a key component of T2DM management; however, rates of PA engagement are low in this population. Developing effective and sustainable interventions that encourage PA is a high priority. Electrically assisted bicycles are becoming increasingly popular and may increase PA in healthy adults. This study aimed to provide evidence of the feasibility of conducting a randomized controlled trial to evaluate the efficacy of an e-cycling intervention to increase PA and improve health in individuals with T2DM. METHODS: A parallel-group two-arm randomized, waitlist-controlled pilot study was conducted. Individuals were randomized to either an e-bike intervention or standard care. The intervention incorporated two one-to-one e-bike skills training and behavioural counselling sessions delivered by a community-based cycling charity, followed by a 12-week e-bike loan with two further sessions with the instructors. Feasibility was assessed via measures related to recruitment, retention and intervention implementation. Post-intervention interviews with instructors and participants explored the acceptability of the study procedures and intervention. Clinical, physiological and behavioural outcomes were collected at baseline and post-intervention to evaluate the intervention's potential. RESULTS: Forty participants (M(age) = 57) were randomized, of which 34 were recruited from primary care practices. Thirty-five participants were retained in the trial. The intervention was conducted with high fidelity (> 80% content delivered). E-bike training provided participants with the skills, knowledge and confidence needed to e-bike independently. Instructors reported being more confident delivering the skills training than behavioural counselling, despite acknowledging its importance. The study procedures were found to be acceptable to participants. Between-group differences in change during the intervention were indicative of the interventions potential for improving glucose control, health-related quality of life and cardiorespiratory fitness. Increases in overall device measured moderate-to-vigorous PA behaviour following the intervention were found, and there was evidence that this population self-selected to e-cycle at a moderate intensity. CONCLUSIONS: The study's recruitment, retention, acceptability and potential efficacy support the development of a definitive trial subject to identified refinements. TRIAL REGISTRATION: ISRCTN, ISRCTN67421464 . Registered 17/12/2018. CI - (c) 2023. The Author(s). FAU - Bourne, Jessica E AU - Bourne JE AUID- ORCID: 0000-0002-8213-5376 AD - Centre for Exercise, Nutrition and Health Sciences, School of Policy Studies, University of Bristol, 8 Priory Road, Bristol, BS8 1TZ, UK. jessica.bourne@bristol.ac.uk. AD - NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. jessica.bourne@bristol.ac.uk. FAU - Leary, Sam AU - Leary S AD - NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. FAU - Page, Angie AU - Page A AD - Centre for Exercise, Nutrition and Health Sciences, School of Policy Studies, University of Bristol, 8 Priory Road, Bristol, BS8 1TZ, UK. AD - NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. FAU - Searle, Aidan AU - Searle A AD - NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. FAU - England, Clare AU - England C AD - NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. FAU - Thompson, Dylan AU - Thompson D AD - Department for Health, University of Bath, Bath, BA2 7PB, UK. FAU - Andrews, Robert C AU - Andrews RC AD - Institute of Biomedical and Clinical Sciences, Medical Research, University of Exeter Medical School, RILD Level 3, Barrack Road, Exeter, EX2 5DW, Devon, UK. FAU - Foster, Charlie AU - Foster C AD - Centre for Exercise, Nutrition and Health Sciences, School of Policy Studies, University of Bristol, 8 Priory Road, Bristol, BS8 1TZ, UK. FAU - Cooper, Ashley R AU - Cooper AR AD - Centre for Exercise, Nutrition and Health Sciences, School of Policy Studies, University of Bristol, 8 Priory Road, Bristol, BS8 1TZ, UK. AD - NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK. LA - eng PT - Journal Article DEP - 20230418 PL - England TA - Pilot Feasibility Stud JT - Pilot and feasibility studies JID - 101676536 PMC - PMC10111297 OTO - NOTNLM OT - E-cycling OT - Electrically assisted cycling OT - Physical activity OT - Pilot randomized controlled trial OT - Type 2 diabetes mellitus COIS- The authors declare that they have no competing interests. EDAT- 2023/04/19 00:41 MHDA- 2023/04/19 00:42 PMCR- 2023/04/18 CRDT- 2023/04/19 00:00 PHST- 2022/03/07 00:00 [received] PHST- 2023/03/28 00:00 [accepted] PHST- 2023/04/19 00:42 [medline] PHST- 2023/04/19 00:41 [pubmed] PHST- 2023/04/19 00:00 [entrez] PHST- 2023/04/18 00:00 [pmc-release] AID - 10.1186/s40814-023-01283-5 [pii] AID - 1283 [pii] AID - 10.1186/s40814-023-01283-5 [doi] PST - epublish SO - Pilot Feasibility Stud. 2023 Apr 18;9(1):60. doi: 10.1186/s40814-023-01283-5.