Value And Challenges Of Investigating Real-world Effectiveness Of Exercise Physiology Services For Type-2 Diabetes

Abstract

PURPOSE: The evidence from randomised controlled trials (RCTs) and meta-analyses supports the use of exercise to manage type 2 diabetes (T2D), and most guidelines propose exercise as a cornerstone of clinical management. However, there is a paucity of evidence for how this translates to real-world practices, specifically the effectiveness of exercise in patients with T2D when delivered as part of complex health service models, rather than in tightly controlled research trials. METHODS: A collaboration of universities and health clinics in Australia is addressing this evidence gap by investigating the effectiveness of services provided by Accredited Exercise Physiologists on a range of outcome measures in people with T2D. The novelty of this approach is the authenticity of 1) the sample population, which excludes no one who is referred to the service; and 2) the type of intervention, which is whatever the individual clinic, clinician and/or patient deem suitable for each situation, subject to any cost constraints. This study is a preliminary analysis of the challenges encountered with this real-world research approach and of the population presenting for exercise physiology services in this context. RESULTS: Key challenges encountered were 1) delays in regional ethics committees, 2) participant recruitment particular to each site, 3) attrition, 4) access to medical records. Sixty-two participants (59% female, 65 ± 10 y.o, HbA1c 7 ± 1%, BP 137/77 including 23% stage 1 and 33% Stage 2 hypertension based on ACC levels) have been enrolled to date. All were on 1 or more hypoglycaemic medication, 88% were on 1 or more cardiovascular medication and 83% were on 1 or more other medication. Of those on additional medications the mean number of medications prescribed was 7.5 per person. CONCLUSIONS: The challenges encountered are consistent with similar approaches of translational research. The sample recruited so far is older with more comorbidity and complex polypharmacy, but has relatively good glycaemic control compared to the typical patient population studied in published RCTs. The difficulty in accrual considered alongside the patient characteristics supports the need for more focus on this type of implementation research to inform the real-world evidence for the benefits of exercise, rather than relying only on RCTs.