PONE-D-20-23831

Effects of whole-body electromyostimulation on function, muscle mass, strength, social participation, and falls-efficacy in older people: A randomized trial protocol

PLOS ONE

Dear Dr. MALAGUTI,

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.

The reviewers had some minor concerns about the methods that need to be addressed prior acceptance, particularly the choice of control group needs to be better supported.

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Cameron J. Mitchell, PhD

Academic Editor

PLOS ONE

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3. Thank you for submitting the above manuscript to PLOS ONE. During our internal evaluation of the manuscript, we found significant text overlap between your submission and the following previously published work:

https://link.springer.com/article/10.1007%2Fs11357-013-9575-2

https://www.hindawi.com/journals/ecam/2016/9236809/

https://www.physiotherapyjournal.com/article/S0031-9406(16)30024-4/fulltext

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0221937

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4. There is a discrepancy in the number of participants between the manuscript/ protocol and registry (http://www.ensaiosclinicos.gov.br/rg/RBR-422x64/). Please clarify why this is so.

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"This study is partially funded by FAPEMIG - number APQ-0354-17 –

 Universal Demand 001/2017 and Coordenação de Aperfeiçoamento de Pessoal

de Nível Superior - Brasil (CAPES) – Finance Code 001."

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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: Yes

Reviewer #2: Partly

Reviewer #3: Yes

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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

Reviewer #3: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

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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: Yes

Reviewer #2: Yes

Reviewer #3: No

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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

Reviewer #3: Yes

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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: The investigators propose to conduct a randomized controlled clinical trial with a target accrual of 66. Individuals will be assessed at four time points.

Minor revisions:

1- Abstract, Background: Typographical error: the majority of older people…

2- Line 155: Sample size calculation: Indicate the statistical testing methods which achieves the state power estimates.

3- Line 367: Should time have 4 levels since assessments will be collected at 4 time points?

4- Line 369: State the criteria that will be used to select the underlying covariance structure in the mixed linear model.

Reviewer #2: This manuscript describes the protocol of an 8-week RCT on the effect of whole-body electrical stimulation versus a resistance exercise program in older adults. The study includes a comprehensive set of measures of muscle mass, strength, and function, as well as secondary outcomes related to social participation and falls efficacy. The study protocol seems well thought-through, but I do have the following comments:

Major comments:

1) My main comment is about the aim of the study, based on the hypotheses (line 117): is it really expected that the ‘active control group’ will show greater reductions in strength and FFM than the WB-EMS group? I understand that the longer-term compliance to a RE program is not large, but I find it hard to believe that WB-EMS will have a greater effect on muscle function and strength than supervised resistance exercise. Would it not be better to compare the WB-EMS group with a true control group, doing habitual physical activity only?

2) What gap in the literature will this study fill? What will this study demonstrate that the studies in line 111 haven’t?

3) The sample size calculation is currently unclear: is the study powered to pick up a change in variables in the WB-EMS group, or a difference between both intervention groups?

Minor comments:

1) With n=29 participants per group required for functional lower extremity strength, and a dropout of 5 participants per group, should the sample size not be n=34 per group?

2) Line 79: should this be ‘annual loss’?

3) How will the four free options be decided? (line 218)

4) Line 307: time of day?

5) Line 367: pre-intervention instead of pre-WB-EMS

6) Line 398: why poor adherence to long-term programs relevant for such a short study?

Reviewer #3: Thank you for the opportunity to review this manuscript. In general, it is well written and well designed.

I have just a few comments regarding the methods.

1- I believe that the word “sex” is more appropriated than “gender”.

2- The randomization method should be better described. The authors describe the allocation concealing method with opaque envelopes, which is appropriated. However, how will the random allocation be performed? Will the authors use some software or website for this? Or will the authors draw envelopes? Please clarify.

3- “Pulse width” should be replaced by “pulse duration” as it is measured in time unit.

4- The current amplitude/intensity adjust should be better described. Please give more details. Will the amplitude be increased during the same treatment session?

5- Why the ON time will be longer than the OFF time 6/4? In traditional NMES programs for increase of muscle strength the OFF time is longer than the ON time to avoid fatigue. Please clarify.

6- Why did authors decided to perform 2 sessions per week rather than 3? Are 2 sessions per week an appropriated dose for exercise/electrical stimulation?

7- In the Primary and Secondary Outcomes section the timepoint (s) for each outcome should be described.

8- I suggest some assessment regarding patient’s satisfaction. In introduction authors describe the lack of adherence in exercise programs and suggest the whole-body electromyostimulation as a new training strategy to improve older people’s adherence to the therapeutic programs. Therefore, I believe it is very important to assess the patients’ impressions on this new method compared to the traditional (control group).

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Effects of whole-body electromyostimulation on function, muscle mass, strength, social participation, and falls-efficacy in older people: A randomized trial protocol

PONE-D-20-23831R1

Dear Dr. MALAGUTI,

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.

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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,

Cameron J. Mitchell, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

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: Yes

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?

Reviewer #1: Yes

Reviewer #2: Yes

**********

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: Yes

Reviewer #2: Yes

**********

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: All comments have been adequately addressed.

Reviewer #2: The authors have satisfarily addressed all my comments, and I wish them the best of luck with the study.

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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