Review for 10.1186/s12876-019-0936-x (2019)

Reviewer ’s report  
 
Title: High -intensity interval training and moderate -intensity continuous training in adults with 
Crohn’s disease: a pilot  randomised controlled trial  
 
Version: 1 Date: 31 Dec 2018  
 
Reviewer: Jessica Elia  
 
Reviewer's report:  
 
1. Several of the reviewers as well as the editor asked for an in -depth review of MICT and 
HIIT in the IBD population.  There is sound reasoning for this that must be considered in orde r 
for this manuscript to move forward to publication.  
 
This feasibility study steps into a challenging area.  Feasibility studies do not generally address 
issues of safety.  However, HIIT in the IBD population raises concerns, as extreme caution with 
high intensity cardiovascular training is well documented in the IBD literature. This is 
compounded by the number of subjects who experienced adverse "symptoms" (we will call 
them) during the feasibility study.  This is why the following are crucial:  
a. The int roduction, including a through explanation of MICT v. HIIT in the IBD 
population is so important.  (see specific notes below)  
b. Describe type of HIIT chosen and why it was chosen  
2. The methodology also raised many questions. How was it determined based u pon your 
HITT, MICT, and IBD research and how did you decide to amend it so drastically?  
i. How was everyone who administered the trial across 3 facilities trained?  
ii. Did the subjects perform cardiovascular testing prior to the first training session to 
determine baseline or was that the first session?  Is that when anthropormorphic and other data 
was collected?  This is how you figured out your feasibility…so what did you do and what did 
you decide worked?  Write so it could be replicated.  
iii. Perhaps t est patients at several points throughout the trial to catch a CDAI moving toward 
>400?  
iv. Specific instructions regarding eating and hydration behaviors?  
v. Consider only adult subjects? Over 18?  
vi. Page 23, Line 386: Is not comparing the MICT and HIIT exercise programmes the goal 
of this protocol?  Essentially you are abandoning your protocol and creating a completely new 
study with new interventions.  How does this make your feasibility study a success?  Would this 
not require a new feasibility study?  I would suggest staying with the original protocol as MICT 
and HIIT studies are needed and you do not yet have any data to compare the two or determine 
safety, outcomes, etc.  
3. Please name all tables/figures in manuscript as they will appear in the publi shed article 
ex. (Figure 1) NOT (AdditionalFile2).  Please indicate which tables/figures are supplementary 
ex. (SupplementaryFigure1).  
 
Abstract:  
 
1. Page 10, Line 41:  The "overall attendance rate…"  The trial looked at two different 
groups.  HIIT and MIC T, 62 and 78% participation respectively.  Those numbers should be 
reported separately.  Not taken as an average.  
 
Introduction  
 
2. An adequate rationale for this study has not been presented.  IBD subjects suffer from a 
myriad of extra -intestinal symptoms and complications.  These disease -specific items must be 
addressed within the context of cardiovascular training to reassure rea ders (1) subject safety was 
well understood, considered, and addressed, (2) methodology was given proper consideration, 
(3) suitable outcomes and appropriate objective measures were chosen, and (4) [in a feasibility 
study] is this protocol feasible.  
 
 
3. Page 11, Line 66: The references listed are not from IBD or IBD -similar subjects.  Please 
address:  
a. Why MICT has been the aerobic exercise of choice for IBD subjects both for physiologic 
and functional outcomes.  
b. Why you believe HIIT is a good cardiovas cular exercise choice for IBD subjects and 
discuss the disease specific physiologic benefits and risks.  
c. What the functional subject outcomes/benefits are for utilizing HIIT in terms of exercise 
specificity.  How will this improve the subject's quality o f life?   
d. Physiologic similarities/differences between adult and pediatric IBD  
4. Page 11, Line 73: How did you draw the conclusion that HIIT would be safe for adult 
IBD subjects?   
a. How did you determine the proper HIIT protocol for adult subjects wi th quiescent or 
mild-active CD?  
b. Even if you have published this elsewhere, a brief description is warranted.  
 
Interventions  
 
5. Page 14, Line 136:  Feeling Scale Data should be published with exercise data  
a. Given the questions surrounding the best way  to measure exertion in IBD subjects due to 
autonomic dysfunction, HR, Feeling Scale, and Borg CR -10 data should be published together.  
6. Page 14, Line 146: Please name the standardized questionnaire used.  
7. Page 15, Line 173: Please change "generic heal th status" to "quality of life"  
8. Page 16, Line 193: Please include CONSORT diagram figure number.  
 
Results  
 
9. Page 17, Line 212:  Please include figure number  
 
 
10. Page 19 Line 261 -263: Again, report HIIT and MICT figures separately.  Two separate 
groups were studies, two separate groups should be reported.  
 
 
11. Page 19 Line 267: What does the literature say about 2 v. 3x per week aerobic exercise 
for MICT and HIIT why did you choose 3x per week?  This should be addressed in the 
Introduction  
 
12. Page 19, Line 287: Please give figure number  
 
13. Line 300 -308:  Please distinguish interviewee groups HIIT v. MICT  
 
14. Page 22, Line 359:  IBD population & moderate intensity exercise choice is very clear in 
the literature and should be addressed in the introduction and discussion  
a. Again, what are the physiologic & functional goals  
b. How does the specificity of MICT and HIIT address each differently?  
 
15. Page 22, Line 361: a feasibility trial does not present clinical findings, it cannot say if an  
intervention works, just if a project can be done.  You did no analysis to justify that HIIT 
concerns are not supported.  
 
16. Line 384 I would not remove the HIIT v. MICT component, this has yet to be settled and 
is worthy of further study  
 
17. For data b eing published elsewhere, it is appropriate to provide a brief paragraph 
explaining revelant results and how they informed your conclusions.  
 
 
Recommendations for future trials:  
1. Objectively quantify pre -trial exercise habits: average METS, etc.  
2. Page 17 Line 231:  Consider sex and activity matching groups in future trials  
3. Page 17 Line 226: Consider for future study, limiting control to exercise 2x/week.  Not 
uncommon in exercise studies.  
4. Clearly define exercise goal: intervention group to partic ipate x/wk, total 
x/session/xweeks  
5. Basic patient safety exercise instruction:  
a. stop if you develop a headache, feel faint, dizzy, etc.   
b. brief patient interview prior to each exercise session: change in status ->back to MD for 
clearance (stomach f eels funny)  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
No 
 
Are you able to assess any statistics in the manuscript or would you recommend an  
additional statistical review?  
If an add itional statistical review is recommended, please specify what aspects require further  
assessment in your comments to the editors.  
 
I recommend additional statistical review  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Needs some language corrections before being published  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an  
organisation that may in any way ga in or lose financially from the publication of this  
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisation that may in any way gain or lose  
financially from the publication of this manuscript, either now or in the f uture?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the  
manuscript?  
 
4. Have you received reimbursements, fees, funding, or salary from an organization that 
holds  or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper?  
 
If you can answer no to all of the above, write 'I  declare that I have no competing interests' 
below.  If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests  
 
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