INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST): a randomized controlled trial of percutaneous vertebroplasty

Background: The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body) is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. Methods/Designs: Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma), tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12). Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12) to determine subsequent fracture rates. Our co-primary outcomes are the modified Roland score and pain numerical rating scale at 1 month. Discussion: Although extensively utilized throughout North America for palliation of pain, vertebroplasty still has not undergone rigorous study. The study outlined above represents the first randomized, controlled study that can account for a placebo effect in the setting of vertebroplasty. Trial Registration: Current Controlled Trials ISRCTN81871888.The source of funding for the study and all authors for this publication was National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Integral strategy to supportive care in breast cancer survivors through occupational therapy and a m-health system: design of a randomized clinical trial

Background: Technological support using e-health mobile applications (m-health) is a promising strategy to improve the adherence to healthy lifestyles in breast cancer survivors (excess in energy intake or low physical activity are determinants of the risk of recurrence, second cancers and cancer mortality). Moreover, cancer rehabilitation programs supervised by health professionals are needed due to the inherent characteristics of these breast cancer patients. Our main objective is to compare the clinical efficacy of a m-health lifestyle intervention system alone versus an integral strategy to improve Quality of Life in breast cancer survivors. Methods: This therapeutic superiority study will use a two-arm, assessor blinded parallel RCT design. Women will be eligible if: they are diagnosed of stage I, II or III-A breast cancer; are between 25 and 75 years old; have a Body Mass Index > 25 kg/m2; they have basic ability to use mobile apps; they had completed adjuvant therapy except for hormone therapy; and they have some functional shoulder limitations. Participants will be randomized to one of the following groups: integral group will use a mobile application (BENECA APP) and will receive a face-to-face rehabilitation (8-weeks); m-health group will use the BENECA app for 2-months and will received usual care information. Study endpoints will be assessed after 8 weeks and 6 months. The primary outcome will be Quality of Life measured by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core and breast module. The secondary outcomes: body composition; upper-body functionality (handgrip, Disability of the Arm, Shoulder and Hand questionnaire, goniometry); cognitive function (Wechsler Adult Intelligence Scale, Trail Making Test); anxiety and depression (Hospital Anxiety and Depression Scale); physical fitness (Short version of the Minnesota Leisure Time Physical Activity Questionnaire, Self-Efficacy Scale for Physical Activity); accelerometry and lymphedema. Discussion: This study has been designed to seek to address the new needs for support and treatment of breast cancer survivors, reflecting the emerging need to merge new low cost treatment options with much-needed involvement of health professionals in this type of patients. Trial registration: ClinicalTrials.gov Identifier: NCT02817724 (date of registration: 22/06/2016).The study was funded by the Spanish Ministry of Economy and Competitiveness (Plan Estatal de I + D + I 2013-2016), Fondo de Investigación Sanitaria del Instituto de Salud Carlos III (PI14/01627), Fondos Estructurales de la Unión Europea (FEDER) and by the Spanish Ministry of Education (FPU14/01069). This is part of a Ph.D. Thesis conducted in the Clinical Medicine and Public Health Doctoral Studies of the University of Granada, Spain

French Choral Music from the Renaissance to the 20th Century

For my senior honors project I have recruited and directed a choral ensemble comprised of musicians from the conservatory, college, and community. We are preparing a concert of French music from the 15th and 20th centuries, for which the historical research closely informed the development of my stylistic interpretations, my rehearsal process, and my program notes. The project culminates in a performance on April 29 in Finney Chapel, which includes Fauré\u27s Requiem with choir, orchestra, soloist, organ, and harp

A single bout of moderate-intensity aerobic exercise improves motor learning in premanifest and early Huntington’s disease

IntroductionCardiorespiratory exercise has emerged as a promising candidate to modify disease progression in Huntington’s disease (HD). In animal models, exercise has been found to alter biomarkers of neuroplasticity and delay evidence of disease, and some interventions–including exercise–have shown benefits in human HD patients. In healthy human populations, increasing evidence suggests that even a single bout of exercise can improve motor learning. In this pilot study, we investigated the effect of a single bout of moderate intensity aerobic exercise on motor skill learning in presymptomatic and early manifest HD patients.MethodsParticipants were allocated to either an exercise (n = 10) or control (n = 10) group. They performed either 20 min of moderate intensity cycling or rest before practicing a novel motor task, the sequential visual isometric pinch force task (SVIPT). After 1 week, the retention of the SVIPT was measured in both groups.ResultsWe found that the exercise group performed significantly better during initial task acquisition. There were no significant differences in offline memory consolidation between groups, but total skill gain across both acquisition and retention sessions was greater in the group who exercised. The better performance of the exercise group was driven by improvements in accuracy, rather than speed.DiscussionWe have shown that a single bout of moderate intensity aerobic exercise can facilitate motor skill learning in people with HD gene-expansion. More research is needed to investigate the underlying neural mechanisms and to further explore the potential for neurocognitive and functional benefits of exercise for people with HD.</jats:sec

A single bout of moderate-intensity aerobic exercise improves motor learning in premanifest and early Huntington's disease

IntroductionCardiorespiratory exercise has emerged as a promising candidate to modify disease progression in Huntington's disease (HD). In animal models, exercise has been found to alter biomarkers of neuroplasticity and delay evidence of disease, and some interventions-including exercise-have shown benefits in human HD patients. In healthy human populations, increasing evidence suggests that even a single bout of exercise can improve motor learning. In this pilot study, we investigated the effect of a single bout of moderate intensity aerobic exercise on motor skill learning in presymptomatic and early manifest HD patients. MethodsParticipants were allocated to either an exercise (n = 10) or control (n = 10) group. They performed either 20 min of moderate intensity cycling or rest before practicing a novel motor task, the sequential visual isometric pinch force task (SVIPT). After 1 week, the retention of the SVIPT was measured in both groups. ResultsWe found that the exercise group performed significantly better during initial task acquisition. There were no significant differences in offline memory consolidation between groups, but total skill gain across both acquisition and retention sessions was greater in the group who exercised. The better performance of the exercise group was driven by improvements in accuracy, rather than speed. DiscussionWe have shown that a single bout of moderate intensity aerobic exercise can facilitate motor skill learning in people with HD gene-expansion. More research is needed to investigate the underlying neural mechanisms and to further explore the potential for neurocognitive and functional benefits of exercise for people with HD.ISSN:1664-107

Data_Sheet_1_A single bout of moderate-intensity aerobic exercise improves motor learning in premanifest and early Huntington’s disease.docx

IntroductionCardiorespiratory exercise has emerged as a promising candidate to modify disease progression in Huntington’s disease (HD). In animal models, exercise has been found to alter biomarkers of neuroplasticity and delay evidence of disease, and some interventions–including exercise–have shown benefits in human HD patients. In healthy human populations, increasing evidence suggests that even a single bout of exercise can improve motor learning. In this pilot study, we investigated the effect of a single bout of moderate intensity aerobic exercise on motor skill learning in presymptomatic and early manifest HD patients.MethodsParticipants were allocated to either an exercise (n = 10) or control (n = 10) group. They performed either 20 min of moderate intensity cycling or rest before practicing a novel motor task, the sequential visual isometric pinch force task (SVIPT). After 1 week, the retention of the SVIPT was measured in both groups.ResultsWe found that the exercise group performed significantly better during initial task acquisition. There were no significant differences in offline memory consolidation between groups, but total skill gain across both acquisition and retention sessions was greater in the group who exercised. The better performance of the exercise group was driven by improvements in accuracy, rather than speed.DiscussionWe have shown that a single bout of moderate intensity aerobic exercise can facilitate motor skill learning in people with HD gene-expansion. More research is needed to investigate the underlying neural mechanisms and to further explore the potential for neurocognitive and functional benefits of exercise for people with HD.</p

The Nature of Adverse Childhood Experiences on the Development of Early Maladaptive Schema

Adverse childhood experiences (ACEs), including neglect and physical abuse, were reported at a higher frequency during the COVID-19 pandemic due to social isolation and limited access to public services (Henderson et al., 2020). Prior research suggests that ACEs are associated with adult psychopathology, through the mechanism of early maladaptive schemas, defined using Young’s 18 schemas (Dutra et al., 2008; Young et al., 2003; Zeynel & Uzer, 2020). Children who experience ACEs have unmet core needs, such as insecure attachment and lack of safety, that lead to dysfunctional beliefs about the self, others, and the world (Alaftar & Uzar, 2022). Specifically, Emotional Deprivation, Social Isolation, Mistrust and Vulnerability to Harm have been found to be highly correlated with ACEs (May et al., 2022; Pilkington et al., 2020). While prior research has evaluated associations between ACEs and schema development, there has been no evaluation of the effect of the number of ACEs on schema development. The current study aims to bridge this gap to further understand the relationship between ACEs and early maladaptive schemas that can ultimately inform treatment development. We will also explore whether early maladaptive schemas assessed at pre- treatment are rated present by clinicians who have been working with the patients for at least 10 sessions (i.e., presence of schema's endorsed by the therapist but not the participant). This has implications for the value of the Young Schema Questionnaire as an assessment tool. Participants will include at a minimum 25 adults who are existing patients at the Anxiety and Depression Clinic (ADC) within the Hofstra University Clinical Psychology Department (data will continue to be collected through October so several new participants will be included). Inclusion criteria include being a patient in the ADC, being at least 18 years of age, and having a primary diagnosis of an anxiety or depressive disorder. Exclusion criteria include current psychotic symptoms and/or a current substance use disorder. Participants will complete two self-report questionnaires: The Young Schema Questionnaire Short Form Version 3 (YSQ-S3; Young & Brown, 2005) and the Adverse Childhood Experience Questionnaire for Adults (ACEQ; Felitti et al., 1998). The YSQ-S3 is a component of the standard ADC intake process. ADC patients will be asked for consent to participate in research and complete both the YSQ-S3 and the ACEQ. Demographic information will also be collected. The clinician of each participant will rate their perception of each schema’s presence on a 5-point Likert scale. This provides both self-reported and clinician-reported schema ratings. Beyond sample descriptives, a series of regressions will be conducted to assess ACEs relation to early maladaptive schemas. Specifically, presence/absence of each ACE and total number of ACEs will be examined in relation to severity of each maladaptive schema. Analyses will be conducted using participants’ self-reported schema ratings as the outcome and then repeated using clinician-reported schema ratings as the outcome. Agreement between participants’ self-reported and clinician-reported schema ratings will also be examined. </p