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However, implementing exercise into daily life and long-term adherence remain challenging. To increase a sustainable engagement with physical activity of people with PD, interventions that are motivating, accessible, and scalable are needed. We primarily aim to investigate whether a smartphone app (STEPWISE app) can increase physical activity (i.e., step count) in people with PD over one year. Our second aim is to investigate the potential effects of the intervention on physical fitness, and motor- and non-motor function. Our third aim is to explore whether there is a dose-response relationship between volume of physical activity and our secondary endpoints.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>STEPWISE is a double-blind, randomized controlled trial. We aim to include 452 Dutch people with PD who can walk independently (Hoehn &amp; Yahr stages 1\u20133) and who do not take more than 7,000 steps per day prior to inclusion. Physical activity levels are measured as step counts on the participant\u2019s own smartphone and scaled as percentage of each participant\u2019s baseline. Participants are randomly assigned to an active control group with an increase of 5\u201320% (active controls) or any of the three intervention arms with increases of 25\u2013100% (intermediate dose), 50\u2013200% (large dose), or 100\u2013400% (very large dose). The primary endpoint is change in step count as measured by the STEPWISE smartphone app from baseline to 52 weeks. For our primary aim, we will evaluate the between-group difference in average daily step count change from baseline to 52 weeks. For our second aim, measures of physical fitness, and motor- and non-motor function are included. For our third aim, we will associate 52-week changes in step count with 52-week changes in secondary outcomes.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This trial evaluates the potential of a smartphone-based intervention to increase activity levels in people with PD. We envision that motivational apps will increase adherence to physical activity recommendations and could permit conduct of remote clinical trials of exercise for people with PD or those at risk of PD.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov; NCT04848077; 19\/04\/2021. Clinicaltrials.gov\/ct2\/show\/NCT04848077.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12883-023-03355-8","type":"journal-article","created":{"date-parts":[[2023,9,12]],"date-time":"2023-09-12T06:02:13Z","timestamp":1694498533000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson\u2019s Disease (randomized controlled trial)"],"prefix":"10.1186","volume":"23","author":[{"given":"Sabine","family":"Schootemeijer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nienke M.","family":"de Vries","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric A.","family":"Macklin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kit C.B.","family":"Roes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilde","family":"Joosten","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larsson","family":"Omberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Ascherio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael A.","family":"Schwarzschild","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bastiaan R.","family":"Bloem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,9,12]]},"reference":[{"issue":"5","key":"3355_CR1","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1016\/S1474-4422(18)30499-X","volume":"18","author":"VL Feigin","year":"2019","unstructured":"Feigin VL, et al. 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J Med Syst, 2020. 44(2).","DOI":"10.1007\/s10916-019-1506-z"}],"container-title":["BMC Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12883-023-03355-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12883-023-03355-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12883-023-03355-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,20]],"date-time":"2023-11-20T09:14:58Z","timestamp":1700471698000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcneurol.biomedcentral.com\/articles\/10.1186\/s12883-023-03355-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,12]]},"references-count":50,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["3355"],"URL":"https:\/\/doi.org\/10.1186\/s12883-023-03355-8","relation":{},"ISSN":["1471-2377"],"issn-type":[{"value":"1471-2377","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,12]]},"assertion":[{"value":"22 June 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 August 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 September 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"E.A. Macklin reports receiving grants to his institution on his behalf from AI Therapeutics, Alector, Amylyx, Biohaven, Calico Life Sciences, Chase Therapeutics, Clene Nanomedicine, Denali Therapeutics, Mitsubishi Tanabe Pharma America, Prilenia, Revalesio, Seelos Therapeutics, and UCB Ra Pharma; serving on Steering Committees for Stoparkinson Healthcare and UCB; serving on Data Monitoring Committees for NeuroSense, Novartis, and Sanofi; and serving on advisory boards for Alector, Bial Biotech, Cortexyme, Enterin, InTrance, nQ Medical, and Partner Therapeutics. Prof. Schwarzschild serves on the scientific advisory boards of Michael J. Fox Foundation for Parkinson\u2019s Research SAB (New York, NY) [2017-2019], Cure Parkinson\u2019s Trust foundation Linked Clinical Trials program SAB (London, UK) [~2012- ], Eli Lilly & Company (clinical trial DSMB service) [2018-2021], Prevail Therapeutics (clinical advisory board) [2018-2019], Parkinson\u2019s Foundation (Genetics initiative advisory board) [2018- ], X-linked Dystonia Parkinsonism Clinical Center [2018- ], Denali Therapeutics (clinical advisory board) [2019], NIH\/NIA-funded TOPAZ trial SC via Sutter Health, NIH\/NINDS-funded SPARX3 trial SC, STEPWISE trial SC via Farmer Family Foundation award, Bial Pharmaceuticals (via the Parkinson Study Group), Biogen (via the Parkinson Study Group) [2021- ], UCB (via the Parkinson Study Group) [2022]. He received fees for speaking by Denali Therapeutics (2019), all other speaker fees were fore non-profit entities (Krembil Conference, World Parkinson Congress, Parkinson Study Group, Cure Parkinson\u2019s Trust). Moreover, he performed consultancies for Harvard University (Parkinson\u2019s disease case reviews and epidemiology research) [~2002- ], Eli Lilly & Company (clinical trial DSMB service) [2018-2021], Prevail Therapeutics, Inc (New York City) [2018-2019], Denali Therapeutics (Nice, France) [2019], Parkinson Study Group services to nQ Medical (Cambridge, MA) [2019], Chase Therapeutics (Washington, DC) [2019], Partner Therapeutics (virtual) [2020], Bial (virtual) [2021- ], Biogen (virtual) [2021- ], UCB (virtual) [2022- ]. He received research support by NIH R01 NS110879 (PI) 08\/01\/19 \u2013 05\/31\/24, NIH U01 NS107009 (a PI) 07\/01\/18 to 04\/30\/23, NIH R01NS102735 (Co-Investigator [Xiqun Chen, PI]) 4\/1\/18 - 3\/31\/23, NIH R13 NS111953 (PI) 04\/01\/19 \u2013 03\/31\/22, IH R13 (co-I) 2022-2023, NIH U01 NS090259 (PI) 9\/1\/2015 to 6\/30\/2020, NIH R01 (Collaborator [A. Ascherio, PI]). Prof. Schwarzschild received grant support via his institution (MGH) on projects for which he is the Principal Investigator: (1) Michael J. Fox Foundation\/ASAP (2) Parkinson\u2019s Foundation (3) Farmer Family Foundation. Prof. Schwarzschild served on the editorial advisory board of the Journal of Adenosine and Caffeine Research and Parkinsonism and Related Disorders. Prof. Bloem, currently serves as the co-Editor in Chief for the Journal of Parkinson\u2019s disease, serves on the editorial board of Practical Neurology and Digital Biomarkers, has received fees from serving on the scientific advisory board for UCB, Kyowa Kirin, Zambon and the Critical Path Institute (paid to the Institute), has received fees for speaking at conferences from AbbVie, Biogen, UCB, Zambon, Roche, GE Healthcare, Oruen and Bial (paid to the Institute), and has received research support from the Netherlands Organization for Health Research and Development, the Michael J Fox Foundation, UCB, the Stichting Parkinson Fonds, Hersenstichting Nederland, de Stichting Woelse Waard, Stichting Alkemade-Keuls, de Maag Lever Darm Stichting, Parkinson NL, Davis Phinney Foundation, the Parkinson\u2019s Foundation, Verily Life Sciences, Horizon 2020, the Topsector Life Sciences and Health, Nothing Impossible and the Parkinson Vereniging. Other authors have no competing interests to report.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"The study is performed in accordance with the Declaration of Helsinki. Ethical approval was granted by the medical ethical committee of Arnhem-Nijmegen (NL75501.091.20) and the STEPWISE Parkinson study is registered at clinicaltrials.gov (NCT04848077) on April 19 2021. All participants provided informed-consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"NA.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}],"article-number":"323"}}