PONE-D-24-48588Vibrational Exercise for Crohn’s to Observe Response (VECTOR): Protocol for a Randomized Controlled Trial.PLOS ONE

Dear Dr. Bottoms,

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.

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We look forward to receiving your revised manuscript.

Kind regards,

Amna Aamir Khan, PhD, MScPT, ADPT, BSPT

Academic Editor

PLOS ONE

Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. 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. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match.  When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. 3. Thank you for stating the following financial disclosure: "Funded fully by Crohn's and Colitis Foundation" Please state what role the funders took in the study.  If the funders had no role, please state: ""The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."" If this statement is not correct you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf. 4. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. 5. We note that the original protocol that you have uploaded as a Supporting Information file contains an institutional logo. As this logo is likely copyrighted, we ask that you please remove it from this file and upload an updated version upon resubmission.

Additional Editor Comments:

Editors comments

Subheadings such as "Aims & Objectives," "Rationale," and "Hypotheses" are unnecessary and should be removed.

The term "health-related questionnaires" is vague and insufficient, requiring more elaboration.

Introduction

• The term "Inflammatory bowel diseases" is overly emphasized, while the primary sample, "Crohn's disease," is underrepresented.

Methods

• The methods section is overly complex and filled with unnecessary details, yet critical elements are missing.

• Ethical approval, a fundamental requirement, was not mentioned in right place, which is a significant oversight.

• Exclusion criteria are inadequate. For instance, conditions like knee pain are not addressed, and related protocols remain unclear.

• Secondary outcomes, such as stool biomarkers and VAS for pain assessment, are insufficiently detailed and lack clarity.

In conclusion, your manuscript requires substantial revisions in both scientific content and writing quality. It cannot be accepted in its current state.

Reviewer 1 Comments:

The study can not be blinded to the participants. How will the potential bias be handled?

Sample size calculation needs more details. What are the assumed mean and standard deviation? What test was used?

For the linear mixed model, may consider other covariance matrices in addition to CS.

How will missing data and early termination be handled?

Reviewer 2 Comments:

) Include a brief discussion on potential adverse effects or contraindications of WBV, supported by references.

2) The WBV protocol description is clear but lacks justification for the chosen frequency and amplitude settings. (method section) Provide a brief explanation or reference supporting the selection of the vibration parameters (1.5 mm, 30 Hz).

3) The rationale for selecting specific biomarkers and quality-of-life questionnaires is not fully explained.

4) Justify the inclusion of certain biomarkers (e.g., calprotectin, cytokines) and how they specifically reflect WBV effects.

5) Provide brief captions or explanations for Figure 1 and Figure 2 within the manuscript.

[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: Yes

Reviewer #2: Yes

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: Partly

Reviewer #2: Yes

Reviewer #3: Partly

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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: No

Reviewer #2: Yes

Reviewer #3: 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: No

Reviewer #2: Yes

Reviewer #3: 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: No

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: Thank you for your submission. While your study aims to provide an innovative approach to managing Crohn's disease, it has been found to be insufficient in terms of scientific standards and writing quality. Therefore, your manuscript cannot be accepted for publication in its current form. Below are the reasons for this decision:

General Assessment

• The methodological structure and writing style of your manuscript do not meet the requirements of a scientific publication.

• Significant gaps and inconsistencies are observed in both the introduction and methods sections.

Abstract

• The abstract is overly generic and does not clearly reflect the key points of the study.

• Details about the intervention for the control group are missing.

• The term "health-related questionnaires" is vague and insufficient, requiring more elaboration.

Introduction

• The term "Inflammatory bowel diseases" is overly emphasized, while the primary sample, "Crohn's disease," is underrepresented.

• Subheadings such as "Aims & Objectives," "Rationale," and "Hypotheses" are unnecessary and should be removed.

• Unpublished and small-sample pilot studies should not be presented as evidence but rather with caution.

• The writing style lacks academic rigor and needs to adopt a more professional and formal tone.

Methods

• The methods section is overly complex and filled with unnecessary details, yet critical elements are missing.

• Ethical approval, a fundamental requirement, was not mentioned in right place, which is a significant oversight.

• Exclusion criteria are inadequate. For instance, conditions like knee pain are not addressed, and related protocols remain unclear.

• Secondary outcomes, such as stool biomarkers and VAS for pain assessment, are insufficiently detailed and lack clarity.

Outcome Measures

• The primary and secondary outcome measures lack clear criteria. The focus should shift towards more clinical and measurable outcomes.

Writing and Formatting

• The overall writing style falls short of academic standards. Excessive use of subheadings and overly detailed descriptions result in a lack of focus.

• Headings and subheadings are inconsistent and need careful revision throughout the manuscript.

In conclusion, your manuscript requires substantial revisions in both scientific content and writing quality. It cannot be accepted in its current state.

Reviewer #2: The study can not be blinded to the participants. How will the potential bias be handled?

Sample size calculation needs more details. What are the assumed mean and standard deviation? What test was used?

For the linear mixed model, may consider other covariance matrices in addition to CS.

How will missing data and early termination be handled?

Reviewer #3: 1) Include a brief discussion on potential adverse effects or contraindications of WBV, supported by references.

2) The WBV protocol description is clear but lacks justification for the chosen frequency and amplitude settings. (method section) Provide a brief explanation or reference supporting the selection of the vibration parameters (1.5 mm, 30 Hz).

3) The rationale for selecting specific biomarkers and quality-of-life questionnaires is not fully explained.

4) Justify the inclusion of certain biomarkers (e.g., calprotectin, cytokines) and how they specifically reflect WBV effects.

5) Provide brief captions or explanations for Figure 1 and Figure 2 within the manuscript.

**********

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

Reviewer #3: Yes:  Esedullah AKARAS

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Vibrational Exercise for Crohn’s to Observe Response (VECTOR): Protocol for a Randomized Controlled Trial.

PONE-D-24-48588R1

Dear Dr. Bottoms,

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,

Amna Aamir Khan, PhD, MScPT, ADPT, BSPT

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 #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 #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 #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 #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 #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 #2: All my concerns are addressed.

**********

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 #2: No

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