{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T17:30:46Z","timestamp":1793727046064,"version":"4.6.1"},"reference-count":36,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2024,2,5]],"date-time":"2024-02-05T00:00:00Z","timestamp":1707091200000},"content-version":"unspecified","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003593","name":"Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico","doi-asserted-by":"publisher","award":["302558\/2022-5"],"award-info":[{"award-number":["302558\/2022-5"]}],"id":[{"id":"10.13039\/501100003593","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002322","name":"Coordena\u00e7\u00e3o de Aperfei\u00e7oamento de Pessoal de N\u00edvel Superior","doi-asserted-by":"publisher","award":["Financial code 001"],"award-info":[{"award-number":["Financial code 001"]}],"id":[{"id":"10.13039\/501100002322","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2024,1,19]]},"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Diabetes is a highly prevalent disease that negatively impacts people\u2019s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention\u2014a foot-ankle exercises programme alongside educational strategies\u2014in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, S\u00e3o Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12\u2009week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of S\u00e3o Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05639478\">NCT05639478<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-078958","type":"journal-article","created":{"date-parts":[[2024,2,5]],"date-time":"2024-02-05T22:30:54Z","timestamp":1707172254000},"page":"e078958","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05639478","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Carla B","family":"Rodrigues","sequence":"first","affiliation":[{"name":"School of Medicine, Physical Therapy, Speech and Occupational Therapy Dept, University of S\u00e3o Paulo, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paula N C","family":"Soares","sequence":"additional","affiliation":[{"name":"School of Medicine, Physical Therapy, Speech and Occupational Therapy Dept, University of S\u00e3o Paulo, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana Carolina B","family":"Schmitt","sequence":"additional","affiliation":[{"name":"School of Medicine, Physical Therapy, Speech and Occupational Therapy Dept, University of S\u00e3o Paulo, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3871-7456","authenticated-orcid":false,"given":"Isabel C N","family":"Sacco","sequence":"additional","affiliation":[{"name":"School of Medicine, Physical Therapy, Speech and Occupational Therapy Dept, University of S\u00e3o Paulo, S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,2,5]]},"reference":[{"key":"2025121409030418000_14.2.e078958.1","doi-asserted-by":"crossref","DOI":"10.1186\/s13047-020-00383-2","article-title":"Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer","volume":"13","author":"Armstrong","year":"2020","journal-title":"J Foot Ankle Res"},{"key":"2025121409030418000_14.2.e078958.2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32340-0"},{"key":"2025121409030418000_14.2.e078958.3","unstructured":"Imperatore G , Mayer-davis EJ , Orchard TJ , et al . Prevalence and Incidente of type 1 and incidence of type 1 diabetes among children and adults in the United States and comparison with non-U.S countries. In: Diabetes Am 3rd ed. 2018."},{"key":"2025121409030418000_14.2.e078958.4","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.1046\/j.1463-1326.2000.00003.x","article-title":"Diabetes and vascular disease","volume":"2 Suppl 2","author":"Garber","year":"2000","journal-title":"Diabetes Obes Metab"},{"key":"2025121409030418000_14.2.e078958.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jelekin.2014.04.007"},{"key":"2025121409030418000_14.2.e078958.6","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1016\/j.jelekin.2016.08.006","article-title":"Muscle fiber conduction velocity in different gait phases of early and late-stage diabetic neuropathy","volume":"30","author":"Suda","year":"2016","journal-title":"J Electromyogr Kinesiol"},{"key":"2025121409030418000_14.2.e078958.7","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1002\/dmrr.2737","article-title":"From treatment to preventive actions: improving function in patients with diabetic polyneuropathy","volume":"32","author":"Sacco","year":"2016","journal-title":"Diabetes Metabolism Res"},{"key":"2025121409030418000_14.2.e078958.8","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2474-15-216"},{"key":"2025121409030418000_14.2.e078958.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinbiomech.2013.08.004"},{"key":"2025121409030418000_14.2.e078958.10","doi-asserted-by":"crossref","DOI":"10.1186\/s12984-017-0327-x","article-title":"Muscle force distribution of the lower limbs during walking in diabetic individuals with and without polyneuropathy","volume":"14","author":"Gomes","year":"2017","journal-title":"J Neuroeng Rehabil"},{"key":"2025121409030418000_14.2.e078958.11","doi-asserted-by":"crossref","first-page":"1343","DOI":"10.1007\/s00125-004-1463-y","article-title":"The diabetic foot: from art to science. The 18th Camillo Golgi lecture","volume":"47","author":"Boulton","year":"2004","journal-title":"Diabetologia"},{"key":"2025121409030418000_14.2.e078958.12","doi-asserted-by":"crossref","DOI":"10.1186\/s12891-018-2323-0","article-title":"Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial","volume":"19","author":"Monteiro","year":"2018","journal-title":"BMC Musculoskelet Disord"},{"key":"2025121409030418000_14.2.e078958.13","doi-asserted-by":"crossref","unstructured":"Bus SA , Sacco ICN , Monteiro-Soares M , et al . Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update). Diabetes Metab Res Rev 2023:1\u201320. doi:10.1002\/dmrr.3651","DOI":"10.1007\/s13300-024-01578-7"},{"key":"2025121409030418000_14.2.e078958.14","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1002\/dmrr.2738","article-title":"A shift in priority in diabetic foot care and research: 75% of foot ulcers are preventable","volume":"32","author":"Bus","year":"2016","journal-title":"Diabetes Metabolism Res"},{"key":"2025121409030418000_14.2.e078958.15","unstructured":"Brasil. Minist\u00e9rio da sa\u00fade . Brasil. (2013A) Portaria no 874, De 16 de Maio de 2013. Institui a Pol\u00edtica Nacional para a Preven\u00e7\u00e3o E Controle do C\u00e2ncer NA Rede de Aten\u00e7\u00e3o \u00c0 Sa\u00fade Das Pessoas com Doen\u00e7as Cr\u00f4nicas no \u00c2mbito do Sistema \u00danico de Sa\u00fade (SUS). Se\u00e7\u00e3 Di\u00e1rio Oficial da Uni\u00e3o; 2013."},{"key":"2025121409030418000_14.2.e078958.16","unstructured":"Brasil.Minist\u00e9rio da sa\u00fade . Estrat\u00e9Gias para O Cuidado DA Pessoa com Doen\u00e7A Cr\u00f4Nica: diabetes mellitus; 2006."},{"key":"2025121409030418000_14.2.e078958.17","doi-asserted-by":"publisher","DOI":"10.1007\/s10464-012-9522-x"},{"key":"2025121409030418000_14.2.e078958.18","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3182408812"},{"key":"2025121409030418000_14.2.e078958.19","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.i6795","article-title":"Standards for reporting implementation studies (StaRI) statement","volume":"356","author":"Pinnock","year":"2017","journal-title":"BMJ"},{"key":"2025121409030418000_14.2.e078958.20","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.9941"},{"key":"2025121409030418000_14.2.e078958.21","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1590\/S0066-782X2010005000095","article-title":"Therapeutic inertia and control of high blood pressure in primary health care units","volume":"95","author":"Hoepfner","year":"2010","journal-title":"Arq Bras Cardiol"},{"key":"2025121409030418000_14.2.e078958.22","unstructured":"CONSORT 2010 checklist of information to include when reporting a randomized trial; 2010. 1\u20132."},{"key":"2025121409030418000_14.2.e078958.23","unstructured":"Brasil.Minist\u00e9rio da Sa\u00fade . Revista de Ci\u00eancias do Estado. In: Vigitel Brasil 2019. Vol. 6. 2019: 1\u201312."},{"key":"2025121409030418000_14.2.e078958.24","doi-asserted-by":"crossref","unstructured":"van Netten JJ , Sacco ICN , Lavery L , et al . Clinical and biomechanical effectiveness of foot-ankle exercise programs and weight-bearing activity in people with diabetes and neuropathy: A systematic review and meta-analysis. Diabetes Metab Res Rev 2023:e3649. doi:10.1002\/dmrr.3649","DOI":"10.1002\/dmrr.3649"},{"key":"2025121409030418000_14.2.e078958.25","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0218560","article-title":"Rehabilitation technology for self-care: customised foot and ankle exercise software for people with diabetes","volume":"14","author":"Ferreira","year":"2019","journal-title":"PLoS One"},{"key":"2025121409030418000_14.2.e078958.26","first-page":"100402","article-title":"Development of a customized booklet of foot-ankle exercises for people with diabetes mellitus as a management and prevention tool for musculoskeletal complications","volume":"26","author":"Ver\u00edssimo","year":"2022","journal-title":"BJPT"},{"key":"2025121409030418000_14.2.e078958.27","doi-asserted-by":"publisher","DOI":"10.1007\/s10488-010-0314-z"},{"key":"2025121409030418000_14.2.e078958.28","doi-asserted-by":"publisher","DOI":"10.1186\/1748-5908-4-50"},{"key":"2025121409030418000_14.2.e078958.29","doi-asserted-by":"publisher","DOI":"10.2105\/ajph.89.9.1322"},{"key":"2025121409030418000_14.2.e078958.30","doi-asserted-by":"crossref","DOI":"10.1186\/s13012-021-01111-5","article-title":"Rapid versus traditional qualitative analysis using the consolidated framework for implementation research (CFIR)","volume":"16","author":"Nevedal","year":"2021","journal-title":"Implement Sci"},{"key":"2025121409030418000_14.2.e078958.31","first-page":"222","article-title":"Cross-cultural adaptation and measurement properties of the Brazilian version of the michigan neuropathy screening instrument","volume":"22","author":"Sartor","year":"2018","journal-title":"BJPT"},{"key":"2025121409030418000_14.2.e078958.32","doi-asserted-by":"publisher","DOI":"10.1016\/S1050-6411(00)00027-4"},{"key":"2025121409030418000_14.2.e078958.33","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1186\/1743-0003-11-11","article-title":"Effect of diabetic neuropathy severity classified by a fuzzy model in muscle dynamics during gait","volume":"11","author":"Watari","year":"2014","journal-title":"J Neuroeng Rehabil"},{"key":"2025121409030418000_14.2.e078958.34","doi-asserted-by":"crossref","first-page":"4709","DOI":"10.3390\/app9214709","article-title":"Test-retest reliability of kinematic parameters of timed up and go in people with type 2 diabetes","volume":"9","author":"Dominguez-Mu\u00f1oz","year":"2019","journal-title":"Applied Sciences"},{"issue":"July","key":"2025121409030418000_14.2.e078958.35","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1016\/j.gaitpost.2020.07.011","article-title":"Reliability and validity of an enhanced paper grip test; a simple clinical test for assessing lower limb strength","volume":"81","author":"Chatzistergos","year":"2020","journal-title":"Gait Posture"},{"key":"2025121409030418000_14.2.e078958.36","doi-asserted-by":"crossref","first-page":"664","DOI":"10.20344\/amp.1317","article-title":"Contributos para a valida\u00e7\u00e3o da vers\u00e3o portuguesa do EQ-5D","volume":"26","author":"Ferreira","year":"2013","journal-title":"Acta Med Port"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-078958","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T17:03:17Z","timestamp":1765731797000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-078958"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2]]},"references-count":36,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,2,5]]},"published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1136\/bmjopen-2023-078958"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-078958","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2]]}}}