Immediate Effect of Whole-Body Vibration on Skin Temperature and Lower-Limb Blood Flow in Older Adults with Type 2 Diabetes: Pilot Study

Round 1

Reviewer 1 Report

The research presented, in principle, has an interesting objective for science, for health and as potential work to be cited.

The bibliographic review on the state of the art is complete and helps the reader to situate himself before the problem.

However, the work needs care and attention both in its presentation and in the weakness of the research design itself, since the experiment has only been carried out once and with a very, very small sample.

The attached file points out the improvements in the presentation.
As an example I indicate some of them below:
Line 42: "Sham" appears in lower case and throughout the text it appears indistinctly in upper and lower case.
Line 43: There is a space between º C.
Line 58: Include the number of the quotation after the end point of the sentence when the period is the spelling sign that should close the sentence. This should be corrected throughout the text.
Line 130. Does not indicate the units of measure
Line 136: Does not indicate the units of measurement
Line 140: Not translated into English
Line 144: Does not indicate the units of measurement
Line 212: See recommendations in Table 1 In general it is misaligned, and decimals appear with a comma (,) while in the text they appear with a period (.) There are also unclosed parentheses. The abbreviation MW is not described in the table footer.
Line 222: Please check all corrections in table 2.
Line 232: Please check all corrections in table 3.
Line 278. Wrong authorship.
The Conclusions create confusion because, although it is true, the treatment with vibration produces improvements that are not statistically significant and the size of the effect in almost all of them is very small

Comments for author File: Comments.pdf

Author Response

Brazil, January 5, 2020.

 

Dear Reviewer,

Thanks for the corrections that were suggested. In conversation with the authors we decided to welcome and revise them so that the study will be published as soon as possible.

 

RESPONSE TO REVIEWER 1

 

Line 42: "Sham" appears in lowercase and throughout the text appears indistinctly in uppercase and lowercase.

Response: Thank you for the correction made. We standardize “Sham” with the first letter capitalized and the others lowercase for the entire manuscript.

 

Line 43: There is a space between ° C

Response: Thank you very much for your suggestion. We standardize ° C for the entire manuscript.

 

Line 58: Include the citation number after the end point of the sentence when the end point is the spelling sign that should close the sentence. This must be corrected throughout the text.

Response: Thank you for your attention. We revised all the text and placed as requested.

 

Line 130. Does not indicate units of measure

Response: Thanks for the correction. We have included in the manuscript the missing units of measurement.

 

Line 136: Does not indicate units of measure

Response: We add the information as requested. Thanks.

 

Line 140: Not translated into English

Response: Thank you for your attention. We apologize for the failure and inform you that we have done the missing translation.

 

Line 144: Does not indicate units of measure

Response: Sorry. You have already made the correct corrections. Thanks.

 

Line 212: See recommendations in Table 1 Typically misaligned and decimals appear as (,) while text is displayed with dot (.) There are also unclosed parentheses. The abbreviation MW is not written in the table footer.

Response: We had a problem training while sending the file. Although. We are sending the manuscript with corrections. Thanks for the suggestions. We are sure that corrections made or handwritten were captured with a better read.

 

Line 222: Check all corrections in table 2.

Response: Thank you for making notes in the PDF file. They were instrumental in the corrections that were made. Thanks.

 

Line 232: Check all corrections in table 3.

Response: We apologize for our inattention. We have already made the requested corrections. Thanks.

 

Line 278. Wrong authorship

Response: We made the correction as shown in the reviewer's file. Thanks.

 

The conclusions are confusing because, although true, vibration treatment produces improvements that are not statistically significant and the effect size in almost all of them is very small.

Response: To avoid confusion, we come to a new conclusion. We hope it meets the requirements. Thanks.

 

 

Thank you for your contributions.

 

Have a great year.

 

Sincerely,

Maria das Graças Rodrigues de Araújo.

Author Response File: Author Response.docx

Reviewer 2 Report

Thank you for the opportunity to read your manuscript 'Immediate effect of whole body vibration on skin temperature and lower limb blood flow in elderly people with type 2 diabetes: pilot study'. I have a couple of comments to make to the authors: Keywords: Please, use MeSH terms. Whole body vibration it's not a MeSH term, and in your study you use Type 2 Diabetes Mellitus patients, and there is a MeSH term for this case. Introduction: Be careful the use of acronyms. For example, in the abstract 'post IVC' appears without specifying what it means. In the text of the manuscript it is necessary to indicate the acronym next to the word, although it has appeared in the abstract (e.g.:WBV). The introduction can be improved with most of the articles cited in the discussion. This will place the reader in the context of the study and then the results obtained with those of the other authors can be discussed. Methods: Please indicate the registration number of clinicaltrials.gov. The authors need to specify where they got the patients and by what method. Selection of patients who attended the consultation consecutively? Did they call on diabetic patients to come voluntarily? When I make this observation, I mean the initial selection of the patients, then it is understood in the explanation that the authors randomly assigned them to the two study groups. With the information provided by the authors, I understand that the patients' metabolic control status, such as glycated hemoglobin, was not taken into account for patient selection. Is this assumption true? Discussion: Did your study have limitations? For example, in the selection of the sample there are factors such as the control of the metabolic state that can influence the response of the intervention performed. There is also a gender bias, since 80% and 90% of the participants (intervention group and control group respectively) are women. Also the limitations that concern the conduct of a pilot study. Here you can record the aspects that you consider positive and others that you have seen that can improve in the following phases of the study (medium and long term, for example). Conclusion: Based on the results obtained in the pilot study and the sample size, the authors must formulate the conclusions with caution. They may present the results as favorable but that should be corroborated with more subjects, their effects in the medium and long term ...

Author Response

Brazil, January 2, 2020.

 

Dear Reviewer,

Thanks for the corrections that were suggested. In conversation with the authors we decided to welcome and revise them so that the study will be published as soon as possible.

 

RESPONSE TO REVIEWER 2

 

Thank you for the opportunity to read your manuscript 'Immediate effect of whole body vibration on skin temperature and lower limb blood flow in elderly people with type 2 diabetes: pilot study'. I have a couple of comments to make to the authors: Keywords: Please, use MeSH terms. Whole body vibration it's not a MeSH term, and in your study you use Type 2 Diabetes Mellitus patients, and there is a MeSH term for this case. Introduction: Be careful the use of acronyms. For example, in the abstract 'post IVC' appears without specifying what it means. In the text of the manuscript it is necessary to indicate the acronym next to the word, although it has appeared in the abstract (e.g.:WBV). The introduction can be improved with most of the articles cited in the discussion. This will place the reader in the context of the study and then the results obtained with those of the other authors can be discussed. Methods: Please indicate the registration number of clinicaltrials.gov. The authors need to specify where they got the patients and by what method. Selection of patients who attended the consultation consecutively? Did they call on diabetic patients to come voluntarily? When I make this observation, I mean the initial selection of the patients, then it is understood in the explanation that the authors randomly assigned them to the two study groups. With the information provided by the authors, I understand that the patients' metabolic control status, such as glycated hemoglobin, was not taken into account for patient selection. Is this assumption true? Discussion: Did your study have limitations? For example, in the selection of the sample there are factors such as the control of the metabolic state that can influence the response of the intervention performed. There is also a gender bias, since 80% and 90% of the participants (intervention group and control group respectively) are women. Also the limitations that concern the conduct of a pilot study. Here you can record the aspects that you consider positive and others that you have seen that can improve in the following phases of the study (medium and long term, for example). Conclusion: Based on the results obtained in the pilot study and the sample size, the authors must formulate the conclusions with caution. They may present the results as favorable but that should be corroborated with more subjects, their effects in the medium and long term

Answer: Thank you for reading and reviewing our manuscript. We are sure that your participants want to improve our study and serve our growth as researchers. Their suggestions were discussed between authors and authors. Thanks. We revised as MeSH keywords, corrected as acronyms that were wrong throughout the manuscript. We indicate the registration number in clinictrials.gov. We did not add patient selection manuscripts as needed. An era of glycated hemoglobin considers evidence of disease (diabetes). Regarding gender, we believe that women seek more medical care when compared to men. This justifies a higher percentage of demand from this population for projects such as our lab. We draw a new and more cautious conclusion as suggested.

 

Thank you for your contributions.

 

Have a great year.

 

Sincerely,

Maria das Graças Rodrigues de Araújo.

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report

None

Author Response

Brazil, January 7, 2020.

We appreciate your contributions to the improvement of our manuscript. We are sure that your comments were extremely important for the article to be published soon.

Grateful for the attention.

Kennedy Freitas

Reviewer 2 Report

Thank you for the opportunity to review your manuscript 'Immediate effect of whole body vibration on skin temperature and lower limb blood flow in elderly people with type 2 diabetes: pilot study'. Despite the improvements included in the manuscript, the authors have ignored suggestions that I consider important for the improvement of the manuscript, which I state in this revision:

Keywords: in your study you use Type 2 Diabetes Mellitus patients, and there is a MeSH term for this case.

Introduction: The introduction can be improved with most of the articles cited in the discussion. This will place the reader in the context of the study and then the results obtained with those of the other authors can be discussed.

Methods: If the patients' metabolic control status, such as glycated hemoglobin, was not taken into account for patient selection, authors should state it as a limitation of the study (Or the authors should state that no condition on the metabolic control of diabetes was taken into account). As the International Diabetes Federation includes in its 2017 guide, the general target for glucose control in Type 2 Diabetes should be less than 7% (53 mmol/mol), glycated hemoglobin is not only a diagnostic tool. Reference: International Diabetes Federation. Recommendations For Managing Type 2 Diabetes In Primary Care, 2017. Available in: www.idf.org/managing-type2-diabetes

Discussion: Did your study have limitations? For example, in the selection of the sample there are factors such as the control of the metabolic state that can influence the response of the intervention performed. There is also a gender bias, since 80% and 90% of the participants (intervention group and control group respectively) are women. As you can see in the WHO infographic link (you can check it here https://www.who.int/diabetes/country-profiles/bra_en.pdf?ua=1) of the prevalence of type 2 diabetes in Brazil, it is similar between men and women, hence there is a gender bias. The fact that the authors consider that women consult more than men does not imply that they should be excluded from research. If you look at your conclusions, you do not indicate anything about the gender of the patients and extend them to people with type 2 diabetes.

Also the limitations that concern the conduct of a pilot study. Here you can record the aspects that you consider positive and others that you have seen that can improve in the following phases of the study (medium and long term, for example).

Conclusion: Change the meaning of your conclusion also in the abstract.

Author Response

Brazil, January 7, 2020.

 

Dear Reviewer,

Thanks for the corrections that were suggested. In conversation with the authors we decided to welcome and revise them so that the study will be published as soon as possible.

 

RESPONSE TO REVIEWER 2

 

Keywords: in your study you use Type 2 Diabetes Mellitus patients, and there is a MeSH term for this case.

Answer: Thank you so much for your suggestion.We changed the term as requested. Thank you

 

Introduction: The introduction can be improved with most of the articles cited in the discussion. This will place the reader in the context of the study and then the results obtained with those of the other authors can be discussed.

Answer: Thank you so much for your suggestion. We made the requested improvements for better contextualization. We hope you enjoy the new version. Thank you.

 

Methods: If the patients' metabolic control status, such as glycated hemoglobin, was not taken into account for patient selection, authors should state it as a limitation of the study (Or the authors should state that no condition on the metabolic control of diabetes was taken into account). As the International Diabetes Federation includes in its 2017 guide, the general target for glucose control in Type 2 Diabetes should be less than 7% (53 mmol/mol), glycated hemoglobin is not only a diagnostic tool. Reference: International Diabetes Federation. Recommendations For Managing Type 2 Diabetes In Primary Care, 2017. Available in: www.idf.org/managing-type2-diabetes

Answer: Thank you for your qualified reading and for your recommendations. We decided to adopt as a limitation of the study the non metabolic control. Because the study has a unique intervention characteristic and glycated hemoglobin has an average glycemia over a period of 3 to 4 months. Thanks for the tip.

 

Discussion: Did your study have limitations? For example, in the selection of the sample there are factors such as the control of the metabolic state that can influence the response of the intervention performed. There is also a gender bias, since 80% and 90% of the participants (intervention group and control group respectively) are women. As you can see in the WHO infographic link (you can check it here https://www.who.int/diabetes/country-profiles/bra_en.pdf?ua=1) of the prevalence of type 2 diabetes in Brazil, it is similar between men and women, hence there is a gender bias. The fact that the authors consider that women consult more than men does not imply that they should be excluded from research. If you look at your conclusions, you do not indicate anything about the gender of the patients and extend them to people with type 2 diabetes.

Answer: We are pleased with the very pertinent comments. Thanks. We included the limitations of the study as suggested. We hope to have answered all suggestions. Thank you so much for your contribution.

 

Also the limitations that concern the conduct of a pilot study. Here you can record the aspects that you consider positive and others that you have seen that can improve in the following phases of the study (medium and long term, for example).

 

Answer: Thank you one more time. Suggestions were promptly accepted as requested. We appreciate your review and congratulate you on your excellent work.

 

Conclusion: Change the meaning of your conclusion also in the abstract.

Answer:  Sorry for our failed act. We made the correction. Thank you for your brilliant review. Thank you.

 

Thank you for your contributions.

 

Have a great year.

 

Sincerely,

Maria das Graças Rodrigues de Araújo.

Author Response File: Author Response.doc

Round 3

Reviewer 2 Report

I enjoyed the improvement of the manuscript by the authors, thank you. Happy New Year.