Effect of an Intensive Exercise Intervention Strategy on Modifiable

Cardiovascular Risk Factors in Subjects with Type 2 Diabetes Mellitus

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Critical Appraisal Worksheet

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Elements of Appraisal Discussion

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Study Design

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The study was quantitative. This is due to the use of quantitative data collection and
Was the study a qualitative or quantitative analysis methods. The data collected was empirical data, which was then analyzed

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design? Explain. statistically. Moreover, the relationship between different variables was checked with the
value P. The analyses of how various study variables interact with each other were looked
into. The mentioned are some of the characteristics of quantitative design inherent in the

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study (Balducci et al., 2010)
Practice Problem

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The problem issue that the study focuses on is how to reduce the modifiable risk factors
State the practice problem/issue that is the focus of cardiovascular disease (CVD) that are inherent in type 2 diabetes mellitus (T2DM)

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of the study. patients (Balducci et al., 2010). The CVD risk factors associated with T2DM patients pose a

co rc risk to the patients because the development of the two chronic conditions poses many
difficulties in treatment and maintenance (Balducci et al., 2010).
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Study Purpose
The purpose was assessing the efficacy of an intensive, extensive intervention approach in
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State the purpose of the study. the promotion of physical activity and enhancing hemoglobin A 1c (HbA1c) level and other
risk factors of cardiovascular disease that can be modified in type 2 diabetes mellitus
Discuss whether this study was feasible to (T2DM) patients (Balducci et al., 2010).
conduct in terms of money commitment, the The study was feasible due to the availability of numerous studies that have been
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researchers' expertise, subjects' availability, and conducted on the topic, hence the availability of numerous data to support the study.
ethical considerations. Moreover, the researcher's expertise depicts that the study was feasible. However, the
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amount of money required to collect the data and time was numerous despite the
resources' availability to conduct the study. However, since most of the data (Balducci et
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al., 2010) was collected through self-reported and unsupervised assessments, this has
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 created many data biases. However, the study followed ethics by ensuring that the people
conducting the research were professionals in dealing with the patients, and proper safety
and ethical guidelines were followed (Balducci et al., 2010).
Research Question(s) and Hpothesis(es)
The research question is "what is the efficacy of intensive, extensive intervention

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What is the research question? Is it stated? approach in the promotion of physical activity and enhancing hemoglobin A 1c (HbA1c) level

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and other risk factors of cardiovascular disease that can be modified in type 2 diabetes
mellitus (T2DM) patients?" (Balducci et al., 2010) However, the question is not clearly
What is the research hypothesis? Is it stated? stated

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On the other hand, the research hypothesis based on previous studies is that "intensive,

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extensive intervention approach is effective in the promotion of physical activity and

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enhancing hemoglobin A1c (HbA1c) level and other risk factors of cardiovascular disease
that can be modified in type 2 diabetes mellitus (T2DM) patients?" (Balducci et al., 2010)

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Study Design
The study design involved a qualitative study that incorporated 606 diabetic patients who
What design was used in the study? Was it the were selected randomly. Any patients with conditions limiting physical activities were

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most appropriate design to answer the study eliminated. However, the design and methods used in the research were stated in a
question? Explain. different document (Balducci et al., 2010). Many variables that are associated with T2DMK

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were recorded after the participants were involved in extensive physical activities. The
Was the design logically linked to the sampling approach was appropriate because it enabled the collection of unbiased and collected

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method and statistical analyses? data. Additionally, the approach enhanced the collection of the data easily, which reduced

Did the design provide a means to examine all co rc the time and money resources that would have been spent (Balducci et al., 2010)
The design was logically properly linked to the sampling method and data analyses
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objectives, questions, or hypotheses? because the collected data were in an empirical form. The comparisons and relationships
between the variables and other statistical calculations were therefore possible. The data
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If there was an intervention (treatment) in the recorded by the patients was validated with the test-retest reliability, which eliminated
study: biases (Balducci et al., 2010).
- what was the intervention? Was it clearly A means of examining all the objectives were provided by measuring many variables, thus
described? allowing the relationship between various aspects and conditions related to the reduction
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of hemoglobin and other components that pose a risk to CVD for T2MD patients (Balducci
- Was the treatment appropriate for et al., 2010).
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examining the study purpose and A standard care treatment regimen was used as an intervention measure. The
hypotheses? intervention aimed at enhancing optimal glycemic, lipid, blood pressure, and body weight
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values. This is in the requirements of current guidelines. This included components that
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 - Did the study framework explain the links
between the treatment (independent
variable) and the proposed outcomes
(dependent variables)?
- Were subjects randomly assigned to the
treatment group, or were the treatment and
comparison groups dependent?
- Were the treatment and comparison group
assignments appropriate for the study?
- Was a protocol developed to promote
consistent implementation of the treatment
to ensure intervention fidelity?
- Did the researcher monitor implementation
of the treatment to ensure consistency?
How might this impact findings?
Study Sample
How large is the sample?
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How was the sample size determined?
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Data Analysis
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What were statistical tests used to analyze data?
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would lower glucose, lipid, and blood pressure as required. Drugs were adjusted
throughout the study to attain the target levels and account for reduced needs (Balducci
et al., 2010). Caloric intake was reduced because all the patients were obese to attain a
negative balance against the energy expended. The treatment was appropriate for the
investigation because it was a requirement and followed the present guidelines for
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conducting such a study (Balducci et al., 2010).
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The subjects were randomly assigned to the comparison groups using a permuted-
randomization software program. However, the assignment of the patients to the groups
was also dependent on the type of diabetes (diet ± oral agents vs. insulin) and age
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(Balducci et al., 2010). The assignment groups were appropriate in conducting the study
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because of the differences in patients' conditions like age and type of diabetes treatment,
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which would affect the study. The protocol was developed to enhance consistency in the
treatment implementation and ensure intervention fidelity because the different
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treatments may affect the study and results differently (Balducci et al., 2010). The
treatment's implementation was monitored to ensure that the study and results were not
affected, thus enhancing consistency and fidelity. This minimized the biases in the
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findings.
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co rc The sample size was large, composing of 606 patients with an allowed dropout rate of
25%. The sample size calculation considered the Hb1c level reduction of a minimum of
0.5% in the EXE and CON groups. The standard deviation of the baseline Hb 1c was 1.6 and
statistical power of 90% (alpha = 0.5) (Balducci et al., 2010)
They compared the patient's characteristics at the baseline involved x 2 test for categorical
variables and unpaired 2-tailed t-test for continuous variables. Logistic regression was also
applied for the analysis of the categorical variables. Additionally, multiple regression and
sensitivity analyses were conducted to account for the changes in medication. McNemar
tests were used to compare the within-group end-of-study vs. the baseline values
(Balducci et al., 2010).
 Adapted from: Gray, J.R., Grove, S. K., & Sutherland, S. (2017). Burns and Grove's The practice of nursing research: Appraisal, synthesis, and generation of evidence (8th ed.). St.
Louis: Elsevier.

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