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Background. Exercise is emerging as an important aspect in the management of disease-related symptoms and functional decline in people with Huntington disease (HD). Long-term evaluation of physical activity and exercise participation in HD has yet to be undertaken. Objective. The objective is to investigate the feasibility of a nested randomized controlled trial (RCT) alongside a longitudinal observational study of physical activity and exercise outcomes in people with HD. Design. This will be a 12-month longitudinal observational study (n = 120) with a nested evaluation of a physical activity intervention (n = 30) compared with usual activity (n = 30) using a 'trial within a cohort' design. Setting. The study will take place in HD specialist clinics in Germany, Spain, and the United States, with intervention delivery in community settings. Participants. The participants will have early-mid--stage HD and be participating in the Enroll-HD study. Intervention. This will be a 12-month physical activity behavioral change intervention, delivered by physical therapists in 18 sessions, targeting uptake of aerobic exercise and increased physical activity. Measurements. All participants (n = 120) will complete Enroll-HD assessments (motor, cognitive, behavioral, and quality of life) at baseline and at 12 months. Additional Physical Activity and Exercise Outcomes in Huntington Disease (PACE-HD) assessments include fitness (predicted maximal oxygen uptake [[Vo.sub.2max]]), self-reported and quantitative measures of physical activity, disease-specific symptoms, and walking endurance. RCT participants (n = 60) will complete an additional battery of quantitative motor assessments and a 6-month interim assessment. Enroll-HD data will be linked to PACE-HD physical activity and fitness data. Limitations. The limitations include that the embedded RCT is open, and assessors at RCT sites are not blinded to participant allocation. Conclusion. PACE-HD will enable determination of the feasibility of long-term physical activity interventions in people with HD. The novel 'trial within a cohort' design and incorporation of data linkage have potential to reduce participant burden. This design could be applied to other neurological diseases and movement disorders where recruitment and retention are challenging., Huntington Disease (HD) is an inherited neurodegenerative disease resulting in the loss of striatal neurons leading to disruption of corticostriatal pathways. HD is characterized by progressive deficits in cognition, behavior, [...]

Background. Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective. This study assessed feasibility and outcomes of a 14-week physical activity self-management and coaching intervention [...]

Background. Task-specific training may be a suitable intervention to address mobility limitations in people with Huntington disease (HD). Objective. The aim of this study was to assess the feasibility and safety of goal-directed, task-specific mobility training for individuals with mid-stage HD. Design. This study was a randomized, blinded, feasibility trial; participants were randomly assigned to control (usual care) and intervention groups. Setting. This multisite study was conducted in 6 sites in the United Kingdom. Patients. Thirty individuals with mid-stage HD (13 men, 17 women; mean age=57.0 years, SD=10.1) were enrolled and randomly assigned to study groups. Intervention. Task-specific training was conducted by physical therapists in participants' homes, focusing on walking, sit-to-stand transfers, and standing, twice a week for 8 weeks. Goal attainment scaling was used to individualize the intervention and monitor achievement of personal goals. Measurements. Adherence and adverse events were recorded. Adjusted between-group comparisons on standardized outcome measures were conducted at 8 and 16 weeks to determine effect sizes. Results. Loss to follow-up was minimal (n=2); adherence in the intervention group was excellent (96.9%). Ninety-two percent of goals were achieved at the end of the intervention; 46% of the participants achieved much better than expected outcomes. Effect sizes on all measures were small. Limitations. Measurements of walking endurance were lacking. Conclusions. The safety of and excellent adherence to a home-based, task-specific training program, in which most participants exceeded goal expectations, are encouraging given the range of motivational, behavioral, and mobility issues in people with HD. The design of the intervention in terms of frequency (dose), intensity (aerobic versus anaerobic), and specificity (focused training on individual tasks) may not have been sufficient to elicit any systematic effects. Thus, a larger-scale trial of this specific intervention does not seem warranted., Huntington disease (HD) is an autosomal dominant, neurodegenerative disease, predominantly affecting the medium spiny neurons of the striatum and resulting in a triad of mobility, cognitive, and behavioral symptoms. Onset [...]

In the Omnicare opinion, the Delaware Supreme Court seemingly changed the rules surrounding the use of defensive strategies in merger agreements in order to reduce their potency. The most shocking [...]

In the aftermath of the recent wave of corporate governance and accounting scandals, federal prosecutors and the Securities and Exchange Commission (SEC) have targeted corporate executives for insider trading violations [...]

Recent corporate scandals and the resulting flurry of legislative and regulatory activity has fostered an atmosphere of intense scrutiny of corporate governance activities. The effect upon institutional shareholders is expected [...]

The Sarbanes-Oxley Act dramatically expands the oversight responsibilities of audit committees. Similarly, the national securities exchanges and associations, notably the NYSE and Nasdaq, have formulated rulemaking initiatives intended to substantially [...]

ObjectiveTo determine if guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF) is non-inferior to individual face-to-face CBT-TF for mild to moderate post-traumatic stress disorder (PTSD) to one traumatic event.DesignPragmatic, multicentre, randomised controlled non-inferiority trial (RAPID).SettingPrimary and secondary mental health settings across the UK’s NHS.Participants196 adults with a primary diagnosis of mild to moderate PTSD were randomised in a 1:1 ratio to one of two interventions, with 82% retention at 16 weeks and 71% retention at 52 weeks. 19 participants and 10 therapists were purposively sampled and interviewed for evaluation of the process.InterventionsUp to 12 face-to-face, manual based, individual CBT-TF sessions, each lasting 60-90 minutes; or guided internet based CBT-TF with an eight step online programme, with up to three hours of contact with a therapist and four brief telephone calls or email contacts between sessions.Main outcome measuresPrimary outcome was the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 16 weeks after randomisation (diagnosis of PTSD based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5). Secondary outcomes included severity of PTSD symptoms at 52 weeks, and functioning, symptoms of depression and anxiety, use of alcohol, and perceived social support at 16 and 52 weeks after randomisation.ResultsNon-inferiority was found at the primary endpoint of 16 weeks on the CAPS-5 (mean difference 1.01, one sided 95% confidence interval −∞ to 3.90, non-inferiority P=0.012). Improvements in CAPS-5 score of more than 60% in the two groups were maintained at 52 weeks, but the non-inferiority results were inconclusive in favour of face-to-face CBT-TF at this time point (3.20, −∞ to 6.00, P=0.15). Guided internet based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF and seemed to be acceptable and well tolerated by participants. The main themes of the qualitative analysis were facilitators and barriers to engagement with guided internet based CBT-TF, treatment outcomes, and considerations for its future implementation.ConclusionsGuided internet based CBT-TF for mild to moderate PTSD to one traumatic event was non-inferior to individual face-to-face CBT-TF and should be considered a first line treatment for people with this condition.Trial registrationISRCTN13697710.