Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: The Seniors Health and Activity Research Program Pilot (SHARP-P) Study, a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial.</p> <p>Methods</p> <p>SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA) and/or cognitive training intervention (CT) in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment.</p> <p>Results</p> <p>Intervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004), the interventions produced marked changes in cognitive and physical performance measures (p≤0.05), and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01). Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome) or 2,000 participants (categorical outcome).</p> <p>Conclusions</p> <p>Good levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible.</p> <p>Trial Registration</p> <p>Clinicaltrials.gov Identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00688155">NCT00688155</a></p

Differential Benefits of Memory Training for Minority Older Adults in the SeniorWISE Study

Purpose: Cognitive training improves mental abilities in older adults, but the benefit to minority elders is unclear. We conducted a subgroup analysis of subjects in the SeniorWISE (Wisdom Is Simply Exploration) trial to examine this issue. Design and Methods: SeniorWISE was a Phase 3 randomized trial that enrolled 265 nondemented community-dwelling older adults aged 65 years and older between 2001 and 2006. Participants were randomly assigned to 12 hr of either memory or health training. Results: The sample was 79% female, 71% Caucasian, 17% Hispanic, and 12% African American. On the Rivermead Behavioural Memory Test (RBMT), 28% of the sample scored normal, 47% scored poor, and 25% impaired. Memory performance changed differently over time depending on the demographic characteristics of participants. Both Hispanics and Blacks performed better than Whites on visual memory, and Blacks performed better over time on instrumental activities of daily living. On all performance measures, lower pretest scores were associated with relatively greater improvements over time. Implications: Our analyses suggested that minority participants received differential benefits from the memory training; however, this remains speculative because the 3 ethnic groups in the sample were not equivalent in size. The question of why Black and Hispanic participants often made greater improvements needs further exploration

Memory enhancement in healthy older adults using a brain plasticity-based training program: A randomized, controlled study

Normal aging is associated with progressive functional losses in perception, cognition, and memory. Although the root causes of age-related cognitive decline are incompletely understood, psychophysical and neuropsychological evidence suggests that a significant contribution stems from poorer signal-to-noise conditions and down-regulated neuromodulatory system function in older brains. Because the brain retains a lifelong capacity for plasticity and adaptive reorganization, dimensions of negative reorganization should be at least partially reversible through the use of an appropriately designed training program. We report here results from such a training program targeting age-related cognitive decline. Data from a randomized, controlled trial using standardized measures of neuropsychological function as outcomes are presented. Significant improvements in assessments directly related to the training tasks and significant generalization of improvements to nonrelated standardized neuropsychological measures of memory (effect size of 0.25) were documented in the group using the training program. Memory enhancement appeared to be sustained after a 3-month no-contact follow-up period. Matched active control and no-contact control groups showed no significant change in memory function after training or at the 3-month follow-up. This study demonstrates that intensive, plasticity-engaging training can result in an enhancement of cognitive function in normal mature adults

Foreign Policy and Dyadic Identities: the Role of the CFSP

The article presents an innovative way of looking at the second pillar of the EU (CFSP): not merely a foreign policy instrument, but as an identity forum. The article introduces the role of identity as an analytical took by which to judge the national and trans-national tensions inherent in EU foreign policy-making and suggests that ‘enhanced cooperation’ may soon present itself as a new foreign policy tool for EU practitioners and analysts alike