Economic evaluation plan (EEP) for a very early rehabilitation trial (AVERT): an international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset

RATIONALE: A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection. AIM AND HYPOTHESIS: To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data. SAMPLE SIZE ESTIMATES: Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial. METHODS AND DESIGN: Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended. STUDY OUTCOME: The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life. DISCUSSION: Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke.

Concurrent transcranial direct current stimulation and progressive resistance training in Parkinson's disease: study protocol for a randomised controlled trial

BACKGROUND: Parkinson's disease (PD) results from a loss of dopamine in the brain, leading to movement dysfunctions such as bradykinesia, postural instability, resting tremor and muscle rigidity. Furthermore, dopamine deficiency in PD has been shown to result in maladaptive plasticity of the primary motor cortex (M1). Progressive resistance training (PRT) is a popular intervention in PD that improves muscular strength and results in clinically significant improvements on the Unified Parkinson's Disease Rating Scale (UPDRS). In separate studies, the application of anodal transcranial direct current stimulation (a-tDCS) to the M1 has been shown to improve motor function in PD; however, the combined use of tDCS and PRT has not been investigated.

METHODS/DESIGN: We propose a 6-week, double-blind randomised controlled trial combining M1 tDCS and PRT of the lower body in participants (n = 42) with moderate PD (Hoehn and Yahr scale score 2-4). Supervised lower body PRT combined with functional balance tasks will be performed three times per week with concurrent a-tDCS delivered at 2 mA for 20 minutes (a-tDCS group) or with sham tDCS (sham group). Control participants will receive standard care (control group). Outcome measures will include functional strength, gait speed and variability, balance, neurophysiological function at rest and during movement execution, and the UPDRS motor subscale, measured at baseline, 3 weeks (during), 6 weeks (post), and 9 weeks (retention). Ethical approval has been granted by the Deakin University Human Research Ethics Committee (project number 2015-014), and the trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615001241527).

DISCUSSION: This will be the first randomised controlled trial to combine PRT and a-tDCS targeting balance and gait in people with PD. The study will elucidate the functional, clinical and neurophysiological outcomes of combined PRT and a-tDCS. It is hypothesised that combined PRT and a-tDCS will significantly improve lower limb strength, postural sway, gait speed and stride variability compared with PRT with sham tDCS. Further, we hypothesise that pre-frontal cortex activation during dual-task cognitive and gait/balance activities will be reduced, and that M1 excitability and inhibition will be augmented, following the combined PRT and a-tDCS intervention.

Variations in area-level disadvantage of Australian registered fitness trainers usual training locations

BACKGROUND: Leisure-time physical activity and strength training participation levels are low and socioeconomically distributed. Fitness trainers (e.g. gym/group instructors) may have a role in increasing these participation levels. However, it is not known whether the training location and characteristics of Australian fitness trainers vary between areas that differ in socioeconomic status.

METHODS: In 2014, a sample of 1,189 Australian trainers completed an online survey with questions about personal and fitness industry-related characteristics (e.g. qualifications, setting, and experience) and postcode of their usual training location. The Australian Bureau of Statistics 'Index of Relative Socioeconomic Disadvantage' (IRSD) was matched to training location and used to assess where fitness professionals trained and whether their experience, qualification level and delivery methods differed by area-level disadvantage. Linear regression analysis was used to examine the relationship between IRSD score and selected characteristics adjusting for covariates (e.g. sex, age).

RESULTS: Overall, 47 % of respondents worked in areas within the three least-disadvantaged deciles. In contrast, only 14.8 % worked in the three most-disadvantaged deciles. In adjusted regression models, fitness industry qualification was positively associated with a higher IRSD score (i.e. working in the least-disadvantaged areas) (Cert III: ref; Cert IV β:13.44 [95 % CI 3.86-23.02]; Diploma β:15.77 [95 % CI: 2.17-29.37]; Undergraduate β:23.14 [95 % CI: 9.41-36.86]).

CONCLUSIONS: Fewer Australian fitness trainers work in areas with high levels of socioeconomic disadvantaged areas than in areas with low levels of disadvantage. A higher level of fitness industry qualifications was associated with working in areas with lower levels of disadvantage. Future research should explore the effectiveness of providing incentives that encourage more fitness trainers and those with higher qualifications to work in more socioeconomically disadvantaged areas.