SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.

BACKGROUND: Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy. METHODS: The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition) is a multi-site, double-blinded, five-arm, controlled trial that assesses the potential synergic effect of combined AE and RT on cognition and mobility, with and without cognitive training and vitamin D supplementation in older adults with MCI. Two-hundred participants with MCI aged 60 to 85 years old will be randomized to one of five arms, four of which include combined exercise plus combinations of dual-task cognitive training (real vs. sham) and vitamin D supplementation (3 × 10,000 IU/wk. vs. placebo) in a quasi-factorial design, and one arm which receives all control interventions. The primary outcome measure is the ADAS-Cog (13 and plus modalities) measured at baseline and at 6 months of follow-up. Secondary outcomes include neuroimaging, neuro-cognitive performance, gait and mobility performance, and serum biomarkers of inflammation (C reactive protein and interleukin 6), neuroplasticity (brain-derived neurotropic factor), endothelial markers (vascular endothelial growth factor 1), and vitamin D serum levels. DISCUSSION: The SYNERGIC Trial will establish the efficacy and feasibility of a multimodal intervention to improve cognitive performance and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. TRIAL REGISTRATION: Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .

Intravesical ropivacaine as a novel means of analgesia post-robot-assisted radical prostatectomy: a randomized, double-blind, placebo-controlled trial.

PURPOSE: This study evaluates the safety and efficacy of intravesical ropivacaine as part of a mulitimodal approach to the provision of analgesia after robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: In this double-blind, placebo-controlled trial, 40 patients who were scheduled to undergo RARP for treatment of localized prostate cancer by a single surgeon (SP) were randomized 1:1 to receive either alkalinized intravesical ropivacaine or placebo (0.9% sodium chloride) at the completion of the vesicourethral anastomosis. A standardized general anesthetic was administered in each case. The primary outcome was a reduction in postoperative pain as assessed by a visual analogue scale (VAS). The need for alternate analgesic agents was recorded. Adverse events related to the administration of intravesical ropivacaine were documented prospectively. RESULTS: No serious adverse events related to the administration of intravesical ropivacaine were identified. In the ropivacaine group, there was a significant reduction in the cumulative needed dose of ketoralac relative to placebo at 6 hours postoperatively. There was no statistically significant difference between the groups with regard to pain scores or narcotic use at any time point. CONCLUSIONS: Intravesical administration of ropivacaine may be used safely in the context of RARP and is associated with a significant, albeit modest reduction in the need for supplementary analgesic agents, but did not result in a decrease in postoperative pain scores.