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Exercise may be effective in reducing fracture risk by ameliorating muscle dysfunction and reducing risk of fall, though it is unclear whether it can improve bone quality.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>The \u2018Study to Weigh the Effect of Exercise Training on BONE quality and strength (SWEET BONE) in T2D\u2019 is an open-label, assessor-blinded, randomised clinical trial comparing an exercise training programme of 2-year duration, specifically designed for improving bone quality and strength, with standard care in T2D individuals. Two hundred T2D patients aged 65\u201375 years will be randomised 1:1 to supervised exercise training or standard care, stratified by gender, age \u2264 or &gt;70 years and non-insulin or insulin treatment. The intervention consists of two\u2009weekly supervised sessions, each starting with 5\u2009min of warm-up, followed by 20\u2009min of aerobic training, 30\u2009min of resistance training and 20\u2009min of core stability, balance and flexibility training. Participants will wear weighted vests during aerobic and resistance training. The primary endpoint is baseline to end-of-study change in trabecular bone score, a parameter of bone quality consistently shown to be reduced in T2D. Secondary endpoints include changes in other potential measures of bone quality, as assessed by quantitative ultrasound and peripheral quantitative CT; bone mass; markers of bone turnover; muscle strength, mass and power; balance and gait. Falls and asymptomatic and symptomatic fractures will be evaluated over 7 years, including a 5-year post-trial follow-up. The superiority of the intervention will be assessed by comparing between-groups baseline to end-of-study changes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>This study was approved by the institutional ethics committee. Written informed consent will be obtained from all participants. The study results will be submitted for peer-reviewed publication.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02421393\">NCT02421393<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2018-027429","type":"journal-article","created":{"date-parts":[[2023,4,5]],"date-time":"2023-04-05T17:53:59Z","timestamp":1680717239000},"page":"e027429","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Study to Weigh the Effect of Exercise Training on BONE quality and strength (SWEET BONE) in type 2 diabetes: study protocol for a randomised clinical trial"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct02421393","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Stefano","family":"Balducci","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Conti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Massimo","family":"Sacchetti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cosimo R","family":"Russo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giuseppe","family":"Argento","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2319-869X","authenticated-orcid":false,"given":"Jonida","family":"Haxhi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giorgio","family":"Orlando","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gianvito","family":"Rapisarda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valeria","family":"D'Errico","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrizia","family":"Cardelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luca","family":"Pugliese","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Laghi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martina","family":"Vitale","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lucilla","family":"Bollanti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvano","family":"Zanuso","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Nicolucci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1574-0397","authenticated-orcid":false,"given":"Giuseppe","family":"Pugliese","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,11,4]]},"reference":[{"key":"2023040221280709000_9.11.e027429.1","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-006-0253-4"},{"key":"2023040221280709000_9.11.e027429.2","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwm106"},{"key":"2023040221280709000_9.11.e027429.3","doi-asserted-by":"publisher","DOI":"10.1210\/jc.86.1.32"},{"key":"2023040221280709000_9.11.e027429.4","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.165.14.1612"},{"key":"2023040221280709000_9.11.e027429.5","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-014-3289-6"},{"key":"2023040221280709000_9.11.e027429.6","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2006-0614"},{"key":"2023040221280709000_9.11.e027429.7","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.25.10.1749"},{"key":"2023040221280709000_9.11.e027429.8","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.715"},{"key":"2023040221280709000_9.11.e027429.9","doi-asserted-by":"publisher","DOI":"10.1007\/s40279-013-0100-7"},{"key":"2023040221280709000_9.11.e027429.10","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1016\/j.bone.2015.07.027","article-title":"Determinants of bone strength and quality in diabetes mellitus in humans","volume":"82","author":"Farr","year":"2016","journal-title":"Bone"},{"key":"2023040221280709000_9.11.e027429.11","doi-asserted-by":"crossref","unstructured":"Rubin MR , Patsch JM . 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