Home-based exercise for people living with frailty and chronic kidney disease: A mixed-methods pilot randomised controlled trial

Andrew C. Nixon; Theodoros M. Bampouras; Helen J. Gooch; Hannah M. L. Young; Kenneth W. Finlayson; Neil Pendleton; Sandip Mitra; Mark E. Brady; Ajay P. Dhaygude

doi:10.1371/journal.pone.0251652

Peer Review History

Original SubmissionNovember 18, 2020
13 Jan 2021 Decision Letter - Antony Bayer, Editor PONE-D-20-35665 Home-based exercise for people living with frailty and chronic kidney disease: a mixed-methods pilot randomised controlled trial PLOS ONE Dear Dr. Nixon, Thank you for submitting your manuscript to PLOS ONE. Both reviewers agree that it provides a clear and well presented account of your trial, but they highlight a few minor points of concern. After careful consideration, therefore, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. 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 Feb 06 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. 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Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: I Don't Know ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: Yes ****** 4. 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 ******** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: A pilot randomized controlled trial was conducted to inform the design of a definitive RCT evaluating the effectiveness of home-based exercise intervention in older adults with chronic kidney disease. Primary outcome measures included eligibility, recruitment, adherence, outcome measure completion, and attrition rate. Fifteen participants were randomized to intervention and 14 to usual care. Participant perceived benefits in the areas of fitness, balance, strength, well-being, energy levels and confidence. The study identified challenges with recruitment and retention. Minor revisions: 1- Line 247: Indicate the statistical method(s) used to estimate the 95% confidence intervals. 2- Line 344: The power calculations should include: (1) the estimated outcomes in each group; (2) the α (type I) error level; (3) the statistical power (or the β (type II) error level); (4) the target sample size and (5) for continuous outcomes, the standard deviation of the measurements. Reviewer #2: Nixon et al. reported a pilot RCT regarding home-based exercise for frail elderly patients with advanced CKD. The study is very well structured and performed, and the manuscript is well written. Also, it is a very important and relevant area of research to explore the efficacy and effectiveness of very practical and applicable way of long-term exercise such as home-based exercise in those with CKD. However, current version of manuscript is still immature to be published as it appears. * Although the outcomes are various, several studies of home-based exercise in CKD were already reported elsewhere (Eidemak et al. Nephron 1997, Tang et al. Int J Nurs Pract. 2017, Hiraki et al. Clin Exp Nephrol 2017, Aoike et al. Clin Exp Nephrol 2018, all of which were cited in recent metanalysis paper ; Nakamura et al. Sci Rep 2020) and all of those should be cited and compared to current study in terms of methods/durations/intensities of the exercise, adherence to and completion rate of the protocols, and the outcomes. * One of the major limitations of this study is that exercise was only measured subjectively (diaries and phone calls). This should be also noted and discussed as a major limitation of the study. * Intensity of the exercise seems relatively weak for those with almost normal Barthel Index. Authors should also discuss about this, which might affected the judgement of effect of the exercise. * In Table 3, all the data are presented as mean +- SD, however, I wonder if all data were distributed normally or not. ******** 6. 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.0251652.r001
Revision 1
15 Apr 2021 Author Response Dear Editorial Board, We thank the Editors and Reviewers for taking the time to consider our manuscript ‘Home-based exercise for people living with frailty and chronic kidney disease: a mixed-methods pilot randomised controlled trial’ for publication as a clinical trial in PLOS One. Thank you also for the extension to the time usually permitted for a response. We endeavour to respond to the Academic Editor’s and Reviewers’ points comprehensively below. Academic Editor 1. We have now formatted the manuscript to meet PLOS ONE’s style requirements. 2. We have provided additional information about the eligibility criteria and about the intervention. 3. We have provided additional information on qualitative methodology. 4. We have updated our Competing Interests section. 5. An abstract of preliminary results was presented at an ERA-EDTA conference and the abstract was published in a NDT supplementary issue, associated with the ERA-EDTA conference. The manuscript under consideration for publication in PLOS ONE, however, contains the full details of the study and updated results that have not been published previously. 6. The minimal anonymized data set necessary to replicate study findings is now available at https://doi.org/10.5061/dryad.3ffbg79hp. Reviewer 1 1. We are uncertain as to what is meant by the statistical methods used to calculate the 95% confidence intervals. All 95% confidence intervals were calculated using the described statistical software, e.g. 95% confidence intervals of proportions using R (version 4.0.2, R Foundation for Statistical Computing). We would be happy to revise again if the Reviewer could provide further detail on this point. 2. Thank you for this comment. We have updated the section titled ‘Sample Size Estimation’ to improve clarity. Reviewer 2 1. Thank you for highlighting these papers. We have amended the Introduction to acknowledge the systematic review and meta-analysis, which includes all the mentioned papers. 2. Thank you for highlighting this. We acknowledge that exercise diaries and telephone calls are subject to recall bias, though do not entirely agree that the use of exercise diaries and telephone calls is a major limitation of the study. We have amended the limitations section of the Discussion to address this point. 3. Although participants had a high Barthel Index score, they were assessed as pre-frail or frail using the Frailty Phenotype. There is overlap between disability and frailty, but an individual can be frail without having disability; frailty itself can affect ability to participate in physical activity. Moreover, The American College of Sports Medicine and American Heart Association Guidelines highlight the importance of physical activity being increased gradually in older adults, particularly those that are very deconditioned. Participants used the Borg Rating of Perceived Exertion (RPE) to report their perceived exertion during each exercise session; these scores were used to guide the progression to more challenging exercise levels each week. The intended RPE exercises 2-6 was achieved (mean RPE score for exercises 2-6 was 12+/-2). Considering the above, we do not believe that the intensity of the exercise programme affected the trial feasibility outcomes. 4. Barthel Index scores are now presented as median and interquartile range. The results are presented in the Results section titled ‘Physical Function and Patient Reported Outcome Measures’. Thank you for considering our revised manuscript. We hope that you are satisfied with our responses and we look forward to hearing from you. Yours sincerely, Dr Andrew Nixon Renal Medicine and General Internal Medicine Specialist Trainee Attachments Attachment Submitted filename: Response Letter_April.docx https://doi.org/10.1371/journal.pone.0251652.r002
30 Apr 2021 Decision Letter - Antony Bayer, Editor Home-based exercise for people living with frailty and chronic kidney disease: a mixed-methods pilot randomised controlled trial PONE-D-20-35665R1 Dear Dr. Nixon, Thank you for your thoughtful responses to the issues raised by your original submission. We’re pleased to inform you that your revised 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, Antony Bayer Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0251652.r003
Formally Accepted
22 Jun 2021 Acceptance Letter - Antony Bayer, Editor PONE-D-20-35665R1 Home-based exercise for people living with frailty and chronic kidney disease: a mixed-methods pilot randomised controlled trial Dear Dr. Bampouras: 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 Professor Antony Bayer Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0251652.r004

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