CNA450 Understanding Nursing Research

Section A: Is the basic study design valid for a Randomized controlled trial?

Did the study address a clearly focused research question?

Yes. The article addresses the  focused research question. This is so because the study seeks to answer the question ‘Are there additional benefits for older hypertensive adults in using combined aerobic and resistance training?’ This particular research question is focused because specific about the population studied. For instance, the population studied is ‘older hypertensive adults’. Besides, the intervention provided is concrete and help towards pinning down the research question (Lima et al, 2017). The comparator provided is also clear and easily distinguished from the interventions provided. This is so because the study establishes that combined treatment and aerobic treatment were both effective in reducing abdominal and waist circumference, body mass index and blood pressure. However, the addition of resistance components in the combined exercise helps in cutting down fat mass. The outcomes considered also answer the overall research question raised (Ratan, Anand, Ratan, 2019). 

Was the assignment of participants to interventions randomized?

Yes. The entire process as observed in the study was randomized because the allocation was concealed from both the research participants and the researcher. This is so because in this particular study, the forty-four participants were randomly assigned to the different groups. The allocation of concealment in randomized controlled trial is important because it prevents the researcher from influencing how participants are assigned to intervention groups (Deaton & Cartwright, 2018). 

Were all participants who entered the study accounted for at its conclusion?

Cannot tell. As depicted above, 44 participants were involved. They were randomly divided into different intervention groups but the study does not provide an account of this number in the results, discussion as well as conclusion. For instance, in its conclusion, the randomized trial does not indicate how this number was distributed between the various intervention groups. The study only gives a general conclusion on the results obtained rather than indicating how these participants were distributed between the different intervention groups.

Section B: Was the study methodologically sound?

Were the participants ‘blind’ to intervention they were given?

No. The participants were not blind to the intervention they were giving because prior to the study, participants gave their informed consent and were assessed with a wide range of laboratory tests and structured questionnaires. According to Purcaru et al (2014), informed consent is where a researcher informs the participants on the nature of the study, its benefits, risks as well as an intervention to be used. Participants then make a voluntary decision to either take part in the study or not (Nijhawan et al, 2014).

Since participants were informed on the nature of the study, this clearly indicates that the participants were informed the nature of the research as well as its implications. In this connection, the participants were not ‘blind’ to intervention they were given.

Were the investigators ‘blind’ to the intervention they were giving to participants?

No. The investigators were not blind to the intervention they were giving to participants. In the entire article one tends to observe that there were no blinding methods that have been discussed. With this in mind, one tends to realize that the study investigators were not blind to the interventions targeted to the participants. Also, the investigators were responsible for all activities and experimental work. Also, they ensured all treatments were done appropriately by ensuring that patients obtained specific treatments. Thus, no risks incurred during the treatments.

Aside from the experimental intervention, were the groups treated equally?

Yes. According to the article, after applying the inclusion and exclusion procedure, the remaining 44 participants were treated equally. The methodology section of this article outlines that all participants underwent a 24-hour process after the general assessment. This helped in determining various aspects, such as ambulatory blood pressure monitoring (ABPM). The study protocol section of this article shows that the glucose tolerance test (OGTT) was treated equally (Bunn et al 2019). The entire process was performed with the insulin measurements, but the homeostasis model assessment determined the amount of insulin used. Also, the participants were divided into three subgroups that are: resistance and aerobic training (RAG), control (CG), and aerobic training (AG) were all subjected to 10 consecutive weeks. Each sub-group went three times training for the entire week, and this went for uninterrupted thirty days. The whole idea is that the groups were treated equally; thus being easy to come up with precise data for comparison purposes (Kokic et al 2018).

How large was the treatment effect?

Concerning this article, one tends to identify multiple elements that culminated in the treatment effect applied to the study. Ideally, the study aimed to measure a couple of outcomes, such as the impact of aerobic and resistance training on aerobic exercise on topics such as insulin sensitivity, blood pressure, and body composition in adults. The treatment effect was significant enough, and the primary outcome is supported (Orsano et al 2018). This is based on the results obtained from the targeted groups in this study. Lastly, as indicated in the results section, each work shows precise data supporting the targeted subject matter. The group that incurred resistance and anaerobic training did not indicate risk, which was confirmed by the reduced BP depicted in the 24-hour ABPM. Also, the group's fat mass reduced, which occurred after applying both aerobic training and resistance (Ferrari et al 2017). Also, the other outcome proves that fat mass reduced after working with both workouts, and therefore, there were no cardiovascular cases during the exercise.

How precise was the estimate of the treatment effect?

Based on the confidence interval, (Cl=0.67-0.98) the estimate value is (60%-96%) and this is precise. First of all, the authors outline that those older adults who underwent the resistive training indicate increased workload, 65% on their leg press, and the plantarflexion, which was 95%. These results were obtained after ten weeks of continuous training.

Moreover, at the event (CL=0.345-0.90) this limit is narrow and within the targeted values (20%-26%). The study reveals that VO2 increased by 23.8%, especially for the AG. Additionally, when it came to the RAG group, the results increased by 19.2%. All these results were obtained in both pre and post-training procedures (Annibalini et al 2019). The evidence is crucial since the standard data indicates that VO2 increase by 10% contributes to 15% death reduction of heart-related disorders such as cardiovascular.

Thus, the above outlined outcome shows that the estimate was precise.  

Section C: Will the results help locally?

Can the results be applied to the local population or in your context?

Yes. The entire study shows that all clinical treatments and other procedures used were safe for the participants' bodies. First of all, the article indicates that those groups that underwent the resistance and aerobic training incurred no risks. The data shows that when this group performed exercises, there was a reduction in BP, but no healthcare-related issues were observed in the participants (Mirza & Yaqoob, 2018). The fact is that both groups experienced a couple of physical exercises that were healthier for their bodies. For example, at the end of the study, it was outlined that the fat mass reduced. This happened after the participants applied both resistance and aerobic training. The fact is that physical exercises play a crucial role in managing multiple disorders, especially heart-related infections. Being active makes the body reduce the calories in our body that leads to healthcare diseases.  Ideally, all these concepts applied to the participants can be used to the local population.

Were all clinically important outcomes considered?

No. In the methodology section, I expected to know how drugs can handle blood pressure, insulin sensitivity, and body composition. I expected to get information on how the study used at least a fourth group to happen as a control experiment in this study. There are various types of drugs that can handle disorders such as cardiovascular infections in older people (Lin & Lee, 2018). With this in mind, I expected to get content on the effectiveness of these drugs in managing various elements such as blood pressure, diabetes, and hypertension in elder populations. The fact is that this article lacks information on the effectiveness of different prescribed drugs for the treatment of cardiovascular in the elder population. The authors should have compared how prescribed medicines work in treating hypertension in older people.

Are the benefits worth the harms and costs?

Can't tell. There is no adequate information to show whether the benefits were worth the costs and harms. The fact is that the article has concluded on the problem statement identified. There is no idea of deviations in terms of costs and disadvantages of the targeted benefits. Therefore, based on the missing information in this article, one can conclude that if a larger trial is conducted, then it will be easy to argue that the occurrence of these data is not by chance, and by this time, benefits can worthy as compared to the harms and costs.

 References

Annibalini, G., Lucertini, F., Agostini, D., Vallorani, L., Gioacchini, A., Barbieri, E., ... & Stocchi, V. (2017). Concurrent aerobic and resistance training has anti-inflammatory effects and increases both plasma and leukocyte levels of IGF-1 in late middle-aged type 2 diabetic patients. Oxidative medicine and cellular longevity, 2017. https://www.hindawi.com/journals/omcl/2017/3937842/abs/

Bunn, P. D. S., Lima, N. D. S., Venturini, G. R. D. O., & Silva, E. B. D. (2019). The chronic effects of muscle-resistance training in arterial pressure of hypertensive older adults: a meta-analysis. Fisioterapia em Movimento, 32. https://www.scielo.br/scielo.php?pid=S0103-51502019000100206&script=sci_arttext

Deaton, A., & Cartwright, N. (2018). Understanding and misunderstanding randomized controlled trials. Social Science & Medicine, 210, 2-21. https://www.sciencedirect.com/science/article/pii/S0277953617307359

Ferrari, R., Umpierre, D., Vogel, G., Vieira, P. J., Santos, L. P., de Mello, R. B., ... & Fuchs, S. C. (2017). Effects of concurrent and aerobic exercises on postexercise hypotension in elderly hypertensive men. Experimental gerontology, 98, 1-7. https://www.sciencedirect.com/science/article/pii/S0531556517300414

Kokic, I. S., Ivanisevic, M., Biolo, G., Simunic, B., Kokic, T., & Pisot, R. (2018). Combination of a structured aerobic and resistance exercise improves glycaemic control in pregnant women diagnosed with gestational diabetes mellitus. A randomised controlled trial. Women and birth, 31(4), e232-e238. https://www.sciencedirect.com/science/article/pii/S1871519216302712

Lima, L. G., Bonardi, J., Campos, G. O., Bertani, R. F., Scher, L. M., Moriguti, J. C., ... & Lima, N. K. (2017). Combined aerobic and resistance training: are there additional benefits for older hypertensive adults?. Clinics, 72(6), 363-369. https://www.scielo.br/scielo.php?pid=S1807-59322017000600363&script=sci_arttext

Lin, Y. Y., & Lee, S. D. (2018). Cardiovascular benefits of exercise training in postmenopausal hypertension. International journal of molecular sciences, 19(9), 2523. https://www.mdpi.com/1422-0067/19/9/2523

Mirza, R. A., & Yaqoob, I. (2018). Effects of combined aerobic and virtual reality-based cognitive training on 76 years old diabetic male with mild cognitive impairment. J Coll Physicians Surg Pak, 28(9), S210-S212. https://www.jcpsp.pk/archive/2018/SS_Sep2018/23.pdf

Nijhawan, L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N., & Musmade, P. B. (2013). Informed consent: Issues and challenges. Journal of advanced pharmaceutical technology & research, 4(3), 134. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3777303/

Orsano, V. S. M., de Moraes, W. M. A. M., de Sousa, N. M. F., de Moura, F. C., Tibana, R. A., de Oliveira Silva, A., ... & Prestes, J. (2018). Comparison of the acute effects of traditional versus high velocity resistance training on metabolic, cardiovascular, and psychophysiological responses in elderly hypertensive women. Clinical interventions in aging, 13, 1331. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6074841/

Purcaru, D., Preda, A., Popa, D., Moga, M. A., & Rogozea, L. (2014). Informed consent: how much awareness is there?. PloS one, 9(10), e110139. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0110139

Ratan, S. K., Anand, T., & Ratan, J. (2019). Formulation of research question–Stepwise approach. Journal of Indian Association of Pediatric Surgeons, 24(1), 15. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6322175/

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