PONE-D-23-43186Feasibility and preliminary effects of a Mindfulness-Based Physical Exercise (MBPE) program for community-dwelling older people with sarcopenia: A protocol for a parallel, two-armed pilot randomised controlled trialPLOS ONE

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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: 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

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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: Yes

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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

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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

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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.

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(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Major Revision Required

This seems a very good protocol for a worthwhile, well designed feasibility trial. However, there are some important points that need to be re-examined.

Page Lines

10 181 This statement needs rephrasing from: “… 25 per group will produce at least a small standardised effect size in a main study [46].” to something like “… 25 per group is likely to provide sufficient information for planning the proposed subsequent main randomised trial with an anticipated standardised effect size of about 0.2 [46].”

18 Primary outcomes and measures: This section needs to stipulate somewhere that a primary outcome is also the estimation of the SD for the main endpoint measure. Feasibility relates to statistical aspects of the future trial as well as practicability. See comments below regarding page 24.

23 Probably best not to conduct statistical significance tests with p-values reported, but merely report (say) the mean difference between the two randomised groups with corresponding 95% confidence intervals.

24 Reference [46] states: “When the outcome is a continuous variable, the sample size calculation requires an accurate estimate of the standard deviation of the outcome measure. A pilot trial can be used to get an estimate of the standard deviation, which could then be used to anticipate what may be observed in the main trial. However, an important consideration is that pilot trials often estimate the standard deviation (SD) parameter imprecisely.”

Thus, the main statistical issue in this feasibility study is to provide information to help ascertain a meaningful standardised effect size. This requires an estimate of the SD for the intended main outcome variable for planning the size of the subsequent randomised Phase III controlled trial. Consequently, the Statistical Analysis section should state this explicitly and thus the eventual results section requires the SD to be reported.

This in turn implies that the principal endpoint for the subsequent trial needs to be identified and clearly stipulated in this Protocol.

Some minor points are listed below:

Page Lines

9 169 ‘CONSORT’ is misspelt

11 203 “Prifysgol” is the Welsh language word for “University” so need not be included here.

24 13 Reporting minimum and maximum values rather than quartiles is likely to be more informative.

24 18-19 I cannot imagine ‘generalised estimating equations; will really be necessary.

Reviewer #2: This protocol is an intervention that addresses a very important problem that concerns public health, gerontology and geriatrics due to its magnitude and significance in the healthy aging process. Sarcopenia is a predictor of dependency, loss of autonomy, increased mortality and higher health care costs. Having scientifically verifiable intervention strategies provides an incentive for their application, even more so by including two factors as important as motivation and adherence that are recognized as problems in maintaining a longer-term program. A randomized controlled pilot trial is a good initial design to continue searching for more viable actions and their effects in the prevention of Sarcopenia.

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Reviewer #1: No

Reviewer #2: Yes: Elva Dolores Arias Merino.

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Feasibility and preliminary effects of a Mindfulness-Based Physical Exercise (MBPE) program for community-dwelling older people with sarcopenia: A protocol for a parallel, two-armed pilot randomised controlled trial

PONE-D-23-43186R1

Dear Dr. Kor,

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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Kind regards,

Meryem Merve Ören Çelik

Academic Editor

PLOS ONE

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

**********

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

**********

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

**********

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

**********

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

**********

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: Accept

This seems a very good protocol for a worthwhile and well-designed study. The authors have now included the estimation of the standardised effect size for planning an eventually larger Phase III trial as an objective of this study. However, I remain concerned that the statistical analysis plan over complicates the eventual analysis that will be needed. More focus on confidence intervals rather than p-values from statistical tests of significance is likely to be required.

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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

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