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The present report is a critical analysis of a randomized control trial, reported by Lamb et al. (2018) on the behalf of dementia and physical activity (DAPA) trial investigators. The trial was registered under section of Current Controlled Trials (ISRCTN 10416500)
A brief summary of the paper
The present report summarized a randomized control trial performed over 494 people having dementia. The objective of this work was to conclude the effect of moderate to intense aerobic exercise program on the clinical outcomes related to cognitive and physical improvement. The random allocation of sample population included in this study is 2:1, in conjunction to the group receiving exercise program. The outcomes of intervention was based on cognitive scale assessment for organized Alzheimer disease after 12 months, and secondary outcomes analysis include involvement in routine activities, well-being status, quality of life, and neuropsychiatric behavior. The overall conclusion of this randomized control trial indicates that the effect of aerobic and strength exercises does not reduce d dementia and cognitive related impairment. Furthermore, the treatment intervention only shows improvement in physical fitness, where is are there secondary outcomes shows no significant improvement (Lamb et al. 2018).
Critical analysis according to the CASP guidelines
The framework used for the analysis is based on Critical Appraisal Skills Program (CASP) guidelines (Zeng et al., 2015).
Section A: Are the results of the trail valid?
Focused issue of trial - Yes
This study aims at identifying the clinical efficacy of aerobic and strength exercise on the cognitive improvement of dementia patient. Previous studies have concluded that such intervention not only improves the physical fitness but also have positive effect on cognitive skills it is protective of the dementia type and its corresponding intervention (Forbes et al., 2015). However, these studies are based on low quality methodologies with limited duration of follow-up; as a result of which the heterogeneity of the findings we're unexplained (Groot et al., 2016). The issue of dementia symptoms was considered with national priority, and thus this trial is important to conclude the debate of exercise training importance on control of dementia.
Randomized assignment of patient to treatment - Yes
All the participants in this trial study were qualified for dementia based on DSM-IV (Chagas, Pessoa, & Almeida, 2018), and were able to sit and walk without assistance. The package menswear assist for health conditions such as diabetes, musculoskeletal, and cardiovascular conditions as well as for drugs which might be required during sessions. The exercise group received gym session twice a week for four months which lasts from 60 to 90 minutes. The dementia patient where supervised in 6-8 participants per group with one physiotherapist and one assistant, in order to minimize the cost. The care program related to all participants include counseling far family, clinical assessment, grief advice and physical activities and prescription of symptomatic treatment.
Accounting patient for conclusion - Yes
All the participants were analyzed in accordance to their random a location. The follow-up for all the participants where closest at interval of six months and 12 months, whereas the analysis was made at 12 months. 96% of participants were assigned to exercise among which 88% assist is egress exercise session. 7% of participants report adverse events. The primary outcome data we're based on 83% of participants, among which 75% of participants received motivational telephone calls after the session. The data collected from all the participants were used are multilevel regression model which refrigerants to time point and account for distributed data sampling. The statistical conclusion where based on 95% of confidence level or alpha value 0.05.
Is it worth continuing?
If “blind’ to treatment? - No
Adopted protocol of exercise intervention skills of dementia patient was based on the report of brown et al. (2015). All the participants involved in the clinical trial we're informed about the intervention, objective of the study, and probable outcomes. Hence, consent from all the participants were taken prior to this clinical trial. The design of the study including screening of patients from various settings randomize a location of control and intervention group, assigning responsibilities to physiotherapist and assistant, and involvement of panel for evaluation of the results are carefully determined.
If groups similar the start of trail? - Yes
The prime criteria for selection of participants based on conformation with dementia, according to DSM IV criteria (Chagas et al., 2018). The patients were also qualified for their ability to walk and sit without assistance. In addition to this, the participants were also assessed for health complications and medications that might be available during the intervention session. Thus, it could be mentioned that apart from having the dementia as qualifying criteria for the participants, the factors including perspective and emotional characteristics, acute or chronic health complications, and other traits might differ based on gender, cultural originality, race, other diversity factors. For example, more women (38%) were living along compared to men (8%). Ethnicity-wise, 404 (478) were white and 11 (16) were black, as indicated by final sample population available for primary analysis (and randomized sample).
If the groups treated equally (except from experimental intervention)? - Yes
In order to manage a cost-effective intervention process, the treatment group was further divided into small subgroups of 6-8 participants and are supervised by one physiotherapist and assistant. Based on this, in total 21 physiotherapist and 17 assistant deliver the intervention session with direct interaction to the participants in 1697 sessions. Overall 88% of participants received the physiotherapy assessment.
Section B: What are the results?
How large was treatment effect?
The outcomes considered include progress in cognitive skills as well as physical fitness. The primary outcome include assessment for Alzheimer disease based on cognitive scale (0 to 70 - cognitive impairment and ADAS cog 11 scale) (Nogueira et al., 2018), at 12 months. The secondary outcome were analyzed at 6 and 12 months, based on Bristol activity of daily life index (score 0 to 60, higher value worse impairment) (Parsons et al., 2016), neuropsychiatric index (score 0 to 144, higher value worse symptoms) (Jones et al., 2019) and EQ-5D quality of life measure (score 0-5, higher value better quality) (Svedbom et al., 2018). The primary outcomes indicates worse cognition. The secondary outcomes reflect that only physical fitness is improved, however, no significant improvement were found for other clinical outcomes.
Precision for estimation of treatment effect
Devaluation of assessment criteria reflects that but our usual Care group, 90% of assignment where identified correctly. On the other hand for exercise and physical group, 96% of assignment where identified correctly.
The results of the primary outcome is based on 95% confidence interval, suggesting that the obtained results confirm the alternative hypothesis that physical fitness and exercise does not improve the cognitive skills in dementia. However, the secondary clinical outcomes no evidence was found which suggests improvement in quality of life or neuropsychiatric symptoms. The confidence interval for these results 0.8 to 1.6. The corresponding level of confidence is 95% and alpha value is 0.69.
Section C: Will the results help locally?
Can results be applied to local population? - Yes
It would be justified to state that the results could be applied to local population with dementia. As argued by the office of this clinical study, majority of previous reports except one concludes that physical fitness and aerobic exercise are beneficial to obtain improvement in cognitive skills for dementia people. Hollywood the methodologies used in previous studies were of low quality and there is no explanation for the heterogeneity included for the conclusions. in this perspective, the prison clinical study aerobic and physical exercise dance to worse the cognitive skills and that it have no significant improvement in the quality of life except that the patients becomes physically fit. This study put forward a conclusion that can be used as evidence for future practices in which aerobic and physical exercises will not be included in the treatment of dementia. Additionally, it was also found that the selection of participants for this intervention study, received high number of decline; indicating that physical program related intervention are not attractive for patients.
If clinically important outcomes considered? - Can’t Tell
The present clinical trial only concludes about the effect on cognitive, neuropsychiatric symptoms as well as quality of life. Although the authors have included the effect of other chronic diseases as well as medications, however they were not included within the scope of analysis. Hence, the effect of medications, contraindications, and emotional factors were not considered a difference to the clinical outcomes of physical exercise on dementia treatment.
Are benefits worth the harms and costs? - Yes
The adverse effect with reference to the physical exercise session where found over 7% of participants. Importantly the clinical outcome of this study suggests that physical fitness program can still watch the cognitive skills. These conclusions put forward the notation that physical fitness related interventions are not effective, rather worsening, the dementia conditions. The harm and cost are useful, as they will serve as evidence for future practices. Based on the results of this clinical study, the future intervention and treatment strategies of dementia will not include physical fitness and exercise related options.
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