Experimental study protocol of the project “MOtor function and VItamin D: Toolkit for motor performance and risk Assessment (MOVIDA)”

Valeria Belluscio; Amaranta S. Orejel Bustos; Valentina Camomilla; Francesco Rizzo; Tommaso Sciarra; Marco Gabbianelli; Raffaella Guerriero; Ornella Morsilli; Francesco Martelli; Claudia Giacomozzi

doi:10.1371/journal.pone.0254878

Peer Review History

Original SubmissionFebruary 26, 2021
16 Jun 2021 Decision Letter - Georg Osterhoff, Editor PONE-D-21-06273 Experimental study protocol of the project “MOtor function and VItamin D: toolkit for motor performance and risk Assessment (MOVIDA)” PLOS ONE Dear Dr. Giacomozzi, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jul 29 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. 3. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Additional Editor Comments (if provided): [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Partly Reviewer #2: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Yes Reviewer #2: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes Reviewer #2: No ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: No Reviewer #2: No ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: 1-Please check the spelling of vitamin D and correct it all over the paper; vitamin D or vit D? 2-The rationale of evaluation vitamin D is not clear; please use reference for the prevalence of vitamin D deficiency among military staff and soldiers. Also, please explain why you do not start vitamin D supplementation (even 50000 IU per month) to prevent hypovitaminosis among military staff. Is it not cost effective? 3-Line 171. Please add the reference for WHO classification. 4- Any potential limitations regarding the project? Please add to the discussion. Also you can mention the strength points of this work. Reviewer #2: This study protocol is clearly described, the rationale and motivations well-identified and the manuscript is clearly written and easy to read. Although I think the manuscript is ready for publication, I saw a few unclear aspects and I would like to see them solved if possible: - which devices will be used for the physiological and biomechanical parameters - are they all medical devices? - will biomechanical measurements be performed also in ecological conditions (not in the lab)? - will fatigue be assessed through subjective reporting only? Minor: on line 263 there is an undefined symbol ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0254878.r001
Revision 1
2 Jul 2021 Author Response We thank the Reviewers for the constructive comments. Below, we reported how we have addressed each of the Reviewers’ comments. Corresponding changes have been highlighted in the manuscript. Reviewer #1: 1-Please check the spelling of vitamin D and correct it all over the paper; vitamin D or vit D? Authors. We checked and corrected the incongruencies adopting “Vitamin D” throughout the Manuscript. 2-The rationale of evaluation vitamin D is not clear; please use reference for the prevalence of vitamin D deficiency among military staff and soldiers. Also, please explain why you do not start vitamin D supplementation (even 50000 IU per month) to prevent hypovitaminosis among military staff. Is it not cost effective? Authors. Three answers have been formulated to address this issue. Answer 1. Despite its contribution to altered motor function performance is still partly debated, more and more scientific evidence is reported in the literature which links D hypovitaminosis with stress fractures/injuries, and a high level of interest is found in the literature with respect to the development of effective nutrition plans, at the level of global public health but also with respect to Service Members in the Army. In this study, we aim to monitor the Vitamin D biomarker within our cohort and to possibly include it as a co-variate in our generalized models. This concept has been better clarified in the objectives of the study through the adaptation of point ii of the objective list as follows: “ii) modelling of risk factors interaction, including modelling to associate the assessment outcomes with both retrospective (previous injuries occurred within 2 years) and prospective (during a follow-up period up to 2 years) information; in particular, the Vitamin D biomarker will be monitored within the examined cohort to possibly include it as a relevant co-variate in the models;” Answer 2. The sentence at previous lines 70-72 has been completed with few examples of D hypovitaminosis prevalence, and 2 references have been added purposely, now listed as reference #28 and #29. The sentence has been re-written as follows: “Moreover, in the military populations, there is a significant predisposition to develop low levels of Vitamin D or to undergo relevant level fluctuations [7,9], with reported high D hypovitaminosis incidence and prevalence among soldiers [28-30]. This phenomenon has been partly ascribed to low exposure to sunlight [22] and to the lack of adequately supplemented food [7].” Answer 3. Within the MOVIDA Project, the experimental study had been designed as an observational study, for several reasons but mainly due to the limited duration of the project itself, not enough long for a robust interventional study. However, the developed toolkit may effectively serve as support for interventional studies to reduce injury risk, also addressing D hypovitaminosis treatment. This “potentiality” has been added as a strength in the Discussion, while addressing comment #4. 3-Line 171. Please add the reference for WHO classification. Authors. The following reference has been added as ref #53 “WHO guidelines on physical activity and sedentary behaviour. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO. ISBN 978-92-4-001512-8”. Successive references have been shifted accordingly. A refuse was also corrected in previous line 171, namely the lower limit “1” was replaced by “2.5” which is the proper boundary between sedentary and healthy active adults. 4- Any potential limitations regarding the project? Please add to the discussion. Also you can mention the strength points of this work. Authors. Following this constructive comment, limitations and strengths have been added to the Discussion. The following paragraph has been added: “At a more general level, the overall execution of the project might cope with some possible limitations. First of all, it must be noted that Sars-Cov-2 pandemic situation not only delayed all data collection phases; it also contributed, and is currently contributing, to partial rescheduling of professional and elite sport events which are either suspended, postponed or cancelled, thus resulting in poor availability of enrolled volunteers in the period June-August 2021. In addition, the hot temperatures and the concomitance with the “working summer break” in Italy will further slowdown the experimental phase timeline. As for the strengths and relevance of the overall project, some points are worth to be here highlighted. The toolkit integrates, in a single assessment, several preventive perspectives on the risk of injury, allowing their combined monitoring. Although currently performed with selected, well characterized devices, the protocol is based on off-the-shelf sensors and allows for an easy up-date with evolving sensor market or for being implemented by other research groups with different sensors, provided that quality of the used sensors is similarly assessed. At this stage of the project we want to check the suitability of the protocol in a controlled situation such as the laboratory environment; nevertheless, the whole experimental setup can be moved outside the lab and used in ecological conditions, more similar to those of real-life. Last, despite this project deals with an observational study only, the developed toolkit may effectively serve as support for interventional studies to reduce injury risk, as is might be the case for Vitamin D supplementation studies.” Reviewer #2: This study protocol is clearly described, the rationale and motivations well-identified and the manuscript is clearly written and easy to read. Authors. We want to thank the Reviewer for his/her appreciation and hope to have satisfactorily addressed all below comments Although I think the manuscript is ready for publication, I saw a few unclear aspects and I would like to see them solved if possible: - which devices will be used for the physiological and biomechanical parameters Authors. Devices have been specified in Table 2, column 3 - are they all medical devices? Authors. Certified medical devices had been previously indicated in Table 2, column 3. To better clarify the issue, details have been added (same column) for those devices which are not (or not yet) certified as medical devices. Additionally, a small paragraph has been added ahead of Table 2 to state that all used devices are safe for the use on human volunteers and that all of them have been previously characterized with respect to their technical performance. (“All devices included in the toolkit had been technically characterized and assessed during the first part of the MOVIDA project (implementation of the toolkit) to check the appropriateness of their measurement performance; some of them are certified as medical devices (as indicated in Table 2, column 3); for those which are not, or not yet, technical documentation from the Companies has been checked to guarantee for their safe use on human volunteers”) - will biomechanical measurements be performed also in ecological conditions (not in the lab)? Authors. Thank you for the pertinent comment. At this stage of the project the toolkit is going to be used in lab, since one of our objectives is to check the suitability of the protocol in a controlled situation such as the laboratory environment. Nevertheless, the whole experimental setup can be moved “outside” and used in ecological conditions, more similar to those of real-life. We mentioned this potential strength in the Discussion. - will fatigue be assessed through subjective reporting only? Authors. Fatigue will be monitored and assessed at various levels. As previously reported in Table 2, perceived fatigue will be monitored by using the Borg’s Rating of Perceived Exertion Scale, which has been proved to be highly correlated with both Heart Rate and blood lactate concentration changes during exercise (Scherr et al. Associations between Borg’s rating of perceived exertion and physiological measures of exercise intensity, Eur J Appl Physiol. 2013). Additionally, fatigue will be monitored through Heart Rate continuous measurement (listed in Table 2 as physiological measurement). Last, muscle fatigue indicators will be estimated based on changes of all biomechanical measurements, especially those coming from sEMG. Line “fatigue perception” in Table 2 has been slightly modified for better clarity. Minor: on line 263 there is an undefined symbol Authors. The typo has been corrected. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0254878.r002
6 Jul 2021 Decision Letter - Georg Osterhoff, Editor Experimental study protocol of the project “MOtor function and VItamin D: toolkit for motor performance and risk Assessment (MOVIDA)” PONE-D-21-06273R1 Dear Dr. Giacomozzi, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Georg Osterhoff, M.D. Academic Editor PLOS ONE Additional Editor Comments (optional): The authors addressed all concerns raised by the Reviewers sufficiently. Reviewers' comments: https://doi.org/10.1371/journal.pone.0254878.r003
Formally Accepted
13 Jul 2021 Acceptance Letter - Georg Osterhoff, Editor PONE-D-21-06273R1 Experimental study protocol of the project “MOtor function and VItamin D: toolkit for motor performance and risk Assessment (MOVIDA)” Dear Dr. Giacomozzi: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Georg Osterhoff Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0254878.r004

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