Critical appraisal checklist for Randomized Controlled Trials (RCT)

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Article Title: Sieljacks P, Matzon A, Wernbom M. et al. Muscle Damage and Repeated Bout Effect
Following Blood Flow Restricted Exercise. Eur J Appl Physiol 2016; 116:513-525.
https://doi.org/10.1007/s00421-015-3304-8

Reviewer: Bersano, Matthew

Yes No Unclear NA
1. Was true randomization used for assignment of X
participants to treatment groups?
2. Was allocation to treatment groups concealed? X

3. Were treatment groups similar at the baseline? X

4. Were participants blind to treatment assignment? X

5. Were those delivering treatment blind to treatment X

assignment?
6. Were outcomes assessors blind to treatment X
assignment?
7. Were treatment groups treated identically other X
than the intervention of interest?
8. Was follow up complete and if not, were X
differences between groups in terms of their
follow up adequately described and analyzed?
9. Were participants analyzed in the groups to which X
they were randomized?
10. Were outcomes measured in the same way for X
treatment groups?
11. Were the instruments used to measure outcomes X
reliable and valid?
12. Was appropriate statistical analysis used? X

13. Was the trial design appropriate, and any X

deviations from the standard RCT design
(individual randomization, parallel groups)
accounted for in the conduct and analysis of the
trial?
Overall credibility of article results per your assessment on the scale of 0-10, with 0 –“I don’t trust
the results, as the intervention study outcomes are questionable” to 10 – “I will definitely use the
results of the study in planning interventions for my patients” __5__-

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Explanation of critical appraisal of Randomized Controlled Trial (RCT)

Brief and structured summary of the article in a form of Abstract

The purpose of this study was to determine the muscle damaging effects of blood flow restricted
exercise (BFRE) and to determine if eccentric exercises would provide comparable adaptation for
BFRE as purely exercising with BFRE. The researchers hypothesized that both BFRE and eccentric
exercise would inflict muscle damage and that eccentric exercising would not provide an adaptive
protection for subsequent/future BFRE training. 18 participants were divided into two groups that
did two bouts of exercise. The BB group performed BFRE for both bouts, while the EB group
performed an eccentric exercise for their first bout and BFRE for their second bout. All subjects had
their maximal unilateral knee extensor strength tested 7 days before bout 1, an MRI (quadriceps
cross-sectional area and T2) 4 days before both bouts 1 and 2, and their performance and damage
measurements (muscle function, creatine kinase, myoglobin, and subjective muscle soreness level)
taken directly before each bout as well as 1 hour and 1, 2, 4, and 7 days after each bout of exercise.
The study found that both eccentric exercise and BFRE produce muscle damage as well as provide
similar amounts of protective adaptation against future BFRE. This suggests that eccentric
exercises and BFRE elicit similar mechanisms of damage leading to the need for further research to
confirm this.

1. Was true randomization used for assignment of participants to treatment groups?

Yes, once the desired number of subjects were recruited they were randomly assigned to
one of the two groups. The authors do not clarify what method they used to randomly assign
each subject to a group.

2. Was allocation to groups concealed?

The authors did not indicate whether or not they knew who was in which group before the
study began. Because it was not mentioned, I’m going to assume the authors didn’t take this
into account when creating the methods.

3. Were treatment groups similar at the baseline?

Yes, the two groups consisted of active, healthy young males around 19-25 years old who
had similar baseline data at the beginning of the study.

4. Were participants masked (or blinded) to treatment assignment?

No, the participants were not blinded to their study group. Since one group would have a
pressure cuff on their thigh to restrict blood flow during the first bout of exercise, it wasn’t
possible to conceal who was in which group.

5. Were those delivering treatment blind to treatment assignment?

No, the people delivering the treatment were not blind to the treatment. They had to apply
the pressure cuff to the BFRE group during bout one while the eccentric exercise group did not
have a pressure cuff.

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should be sent to jbisynthesis@adelaide.edu.au.
6. Were outcomes assessors blind to treatment assignment?

This is unclear. The article does not note whether or not the outcome assessors were blind
to the treatment assignment. However, since they don’t directly mention assessors, I believe it
is safe to assume every stage of the study was performed by the same people. Therefore, I
don’t think the outcome assessors were blind.

7. Were treatment groups treated identically other than the intervention of interest?

Yes, other than the first bout of exercise both treatment groups were treated identically.
They both had all the same tests: 1RP, MRI, blood drawing, muscle function, subjective muscle
soreness level.

8. Was follow up complete and if not, were differences between groups in terms of their follow
up adequately described and analyzed?

Follow up was completed. Data was collected from the participants 7 and 4 days before the
experiment; the day of the experiment (before the exercise and 1 hour after the exercise); and
1, 2, 3, 4, and 7 days after the exercise for both bouts of exercise.

9. Were participants analyzed in the groups to which they were randomized?

There is no mention of intention-to-treat in the article. One subject did drop out but the
authors don’t tell us if his data was used in the analysis.

10. Were outcomes measured in the same way for treatment groups?

Yes, both groups received the same tests and assessments with the same instruments and
scales at the same time intervals for both bouts of exercise.

11. Were the instruments used to measure outcomes reliable and valid?

The authors used several different measurement tools to get an accurate representation of
the muscle damage. They had the subjective muscle soreness assessment as well as very
reliable and valid objective tests such as the levels of creatine kinase and myoglobin from the
blood sampling. They also had several other tests such as maximum repetition and muscle
function testings in which they minimized inter-rater variability by using the same machine and
documenting all of the settings of the test and machine.

12. Was appropriate statistical analysis used?

Appropriate statistical analysis was used. The authors used the blood creatine kinase as the
primary outcome to calculate sample size through a power analysis. They had a power of 0.8
and an ɑ of 0.05 for their power analysis. They recruited 9 subjects (the calculated required
number was 7) as insurance incase of dropouts. The Shapiro-Wilk test and QQ plots were used
to determine normality of distribution of the data. Paired and unpaired t tests were used to
assess differences within and between the groups. A one-way ANOVA with a

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 Student-Newman-Keuls post hoc test was used to determine if BFRE and/or eccentric exercise
produced muscle damage.

13. Was the trial design appropriate for the topic, and any deviations from the standard RCT
design accounted for in the conduct and analysis?

The study design was the most appropriate option for the research question. A previous
study was able to be used to calculate an appropriate sample size. The results of the study
indicate the muscle damaging effects of both BFRE and eccentric exercise as well as their
adaptive capabilities for subsequent BFRE. The similar adaptive effects might indicate that
patients can perform eccentric exercises in preparation or substitution of BFRE during training
or therapy. I do think the cost might outweigh the benefit of this study. I’m not aware how
much blood tests cost for creatine kinase and myoglobin but their significance in the study may
make them worth the cost. However, I believe the MRI was a waste of money because no
significant or useful data was gathered using the MRI. No difference was found between the
two groups.

Additional consideration

The impact factor of the European Journal of Applied Physiology is 3.078 as of 2021. It
appears 4 of the authors have a good background in BFRE, muscle damage, or exercise in
general. The others don’t have many or any other articles published under their name making
them less credible. I found one other article that some of the authors collaborated on. It didn’t
look at the same variables but it does seem to be in agreement that BFRE causes a
physiological response indicating muscle damage.

Why you should or should not use this evidence?

BFRE is still a relatively new idea but the research doesn’t appear to go contrary to any
previously conceived ideas of muscle damage and adaptation. The interventions aren’t tedious
or costly to implement in the clinic and neither have significant risks associated with them if
the therapist has sound clinical reasoning (i.e. consider contraindications before using BFRE on
individuals with cardiovascular issues). However, I don’t believe this article alone should be
cited to justify using or not using BFRE or eccentric exercises during training or therapy. I think
it would be useful if other articles are used to back its data up or if it were used as a
foundational work to build more research off of.

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should be sent to jbisynthesis@adelaide.edu.au.