Effects of aerobic and resistance training on hemoglobin A1c levels in patients with type 2 diabetes

Running head: CASP
PICO Question
P (Population) Suffering from type 2 diabetes mellitus
I (Intervention) Physical activity
C (Comparison) No physical activity
O (Outcome) Improvement in the disease state of diabetes mellitus
Question
Whether practice of physical activity helps in improving the overall disease state of
type 2 diabetes mellitus (T2DM)?
Article selected
Church, T.S., Blair, S.N., Cocreham, S., Johannsen, N., Johnson, W., Kramer, K., Mikus,
C.R., Myers, V., Nauta, M., Rodarte, R.Q. and Sparks, L., 2010. Effects of aerobic and
resistance training on hemoglobin A1c levels in patients with type 2 diabetes: a randomized
controlled trial. Jama, 304(20), pp.2253-2262.
Critical analysis tool
CASP tool for RCT

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Answer 1
Yes.
The article highlighted that main population of interest over which the analysis is required to
be undertaken and this include men and women in Louisiana who led a sedentary life and is
suffering from T2DM with high HbA1c.
The main interventions given to the population include resistance training for 3 days a week
for one group (72 individuals) and another group (72 individuals) to aerobic exercise training
(12 kcal/kg per week and rest 76 individuals (10 kcal/kg per week) are given combined
aerobic and resistance training.
The comparison was done with the control group (no exercise control group).
The outcomes that are considered include change in the HB1c level and the secondary
outcomes are anthropometry and fitness.
Thus, the issue is focused with all the important term of the assignment.
Answer 2
Yes.
Health Benefits of Aerobic and Resistance Training in individuals with type 2
diabetes (HART-D) study was randomized for 9-month of exercise intervention with a
control group. Initially 2421 individuals were screened for the eligibility. Of them 1139 were
excluded (declines, non-diabetic, enrolled to other studies, taking medications and exceed the
preferred age). 1282 were found eligible of them finally 262 were selected for the final study.
Among them 41 were included to the control group and rest in the study group. The division

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of 262 participants in the experimental and the control group was done randomly and the
allocation sequence was concealed from researchers and the patients. According to Opie
(2019), randomization of the participants in the RCT study helps to improve the outcome of
the results by reducing the selection bias.
Answer 3
No.
All the patients who entered in the trial, do not accounted for its conclusion. This is
because, in the control group (41), 4 lost follow-up, in the randomized group to resistance
training (73), 5 participants lost follow-up). In the group of randomized to aerobic exercise
training (72), 3 lost to take part in the follow-up session and the number of 5 for the
randomized to combination exercise group (76). Thus, the total of the 262 participants, only
245 complete the study. Moreover, the level of adherence of the physical exercise was less in
70 % among some of the participants of the experimental groups. Thus, though the trial was
not stopped early, but the follow-up session lead to participants’ dropout and thereby
reducing the overall strength of the study. The patient analyzed in groups. However, the
analysis was based on intent-to-treat analysis and per-protocol analysis.
Answer 4
No.
Members of the HART-D scientific advisory committee recommended that the
placebo group is required to be monitored stringently. Safety monitoring of the control group
included blinded monitoring of the levels of HbA1c. The blinding of the placebo group was
withdrawn after seven of the participants of the placebo group (17.1%) experienced increase
in the level of HbA1c by 1.0% or higher. However, the separate intervention and the

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assessment teams who were used for the analysis of the results ere blinded to the participants
randomization assignment. Thus, the study is single blinded randomized control trial.
According to Teare et al. (2014) double blinded randomized control trail score more in the
domain of reliability and validity of the study in comparison to the single blinded trial. The
unbinding of the placebo group might lead to the generation of placebo effects.
Answer 5
Yes.
All the groups were similar before the initial of the trial. During the initial of the trial
first 1139 prospective individuals who were screened were excluded from 2421 group. Apart
from excluding the declined o non-interested group, the screened individuals were excluded
if they were non-diabetic, average age not meeting 55.8 years, BMI not meeting the limit of
greater than/equals to 48.0. The main criteria for the selection of the participant include both,
women of them 63% are women, and 47.3% were nonwhite participants. The age group of
the participants resides with the average bar of 55.8 years with a baseline HbA1c level of
7.7%. The individuals who lead a sedentary life were only included in the study. Teare et al.
(2014) are of the opinion that having uniform inclusion criteria for recruiting of the
individuals in the RCT helps to increase the validity of the study. Having the same
demographic characteristics of the individuals in the RCT helps to get uniform baseline data
and thus reducing the level of bias.
Answer 6
Yes.