Implementation of an Evidence-Based, Tai Ji Quan Fall Prevention Program in Rural West Virginia Churches: A RE-AIM Evaluation.

This study implemented a 16-week Tai Ji Quan: Moving for Better Balance® intervention for older adults in churches in hard-to-reach, medically underserved, rural communities, and evaluated the process using the RE-AIM Framework. Community-dwelling adults, aged 55 years, or older, were eligible. Data (N = 237) were collected at baseline, 16 weeks, and 32 weeks on falls efficacy, depression, physical/mental health-related quality of life, aerobic activity, gait speed, mobility, balance, and leg strength. Generalized/linear mixed models determined if outcomes improved. Eighteen churches sponsored 16 classes. Church adoption was 94%, instructor adoption was 86%, reach was 90%, and fidelity was good/fair. All outcomes improved except physical health-related quality of life and gait speed. Thirty-six percent of participants, 28% of churches, and 37% of instructors continued Tai Ji Quan: Moving for Better Balance at 32 weeks. Compared with two prior RE-AIM evaluations, adoption and reach rates, improvements in outcomes, and satisfaction were comparable; attendance, program completion, and continuation rates were lower.

Redox imbalance in COVID-19 pathophysiology.

BACKGROUND: The pathophysiologic significance of redox imbalance is unquestionable as numerous reports and topic reviews indicate alterations in redox parameters during corona virus disease 2019 (COVID-19). However, a more comprehensive understanding of redox-related parameters in the context of COVID-19-mediated inflammation and pathophysiology is required. METHODS: COVID-19 subjects (n = 64) and control subjects (n = 19) were enrolled, and blood was drawn within 72 h of diagnosis. Serum multiplex assays and peripheral blood mRNA sequencing was performed. Oxidant/free radical (electron paramagnetic resonance (EPR) spectroscopy, nitrite-nitrate assay) and antioxidant (ferrous reducing ability of serum assay and high-performance liquid chromatography) were performed. Multivariate analyses were performed to evaluate potential of indicated parameters to predict clinical outcome. RESULTS: Significantly greater levels of multiple inflammatory and vascular markers were quantified in the subjects admitted to the ICU compared to non-ICU subjects. Gene set enrichment analyses indicated significant enhancement of oxidant related pathways and biochemical assays confirmed a significant increase in free radical production and uric acid reduction in COVID-19 subjects. Multivariate analyses confirmed a positive association between serum levels of VCAM-1, ICAM-1 and a negative association between the abundance of one electron oxidants (detected by ascorbate radical formation) and mortality in COVID subjects while IL-17c and TSLP levels predicted need for intensive care in COVID-19 subjects. CONCLUSION: Herein we demonstrate a significant redox imbalance during COVID-19 infection affirming the potential for manipulation of oxidative stress pathways as a new therapeutic strategy COVID-19. However, further work is requisite for detailed identification of oxidants (O2•-, H2O2 and/or circulating transition metals such as Fe or Cu) contributing to this imbalance to avoid the repetition of failures using non-specific antioxidant supplementation.

An Exploratory Randomized Controlled Trial of a 12-Week Yoga Versus Educational Film Program for the Management of Restless Legs Syndrome: Feasibility and Acceptability.

Objectives: The primary objectives of this pilot trial were to assess the study feasibility and acceptability of the 12-week yoga and educational film programs for the management of restless legs syndrome (RLS) in preparation for a future randomized controlled trial (RCT). Materials and Methods: This pilot, parallel-arm, randomized feasibility trial was conducted at two sites, Morgantown, WV and Columbus, OH. Yoga group participants attended 75-min Iyengar yoga classes, twice weekly for 4 weeks, then once a week for 8 weeks (16 total classes), and completed a 30-min homework routine on nonclass days. Educational film group participants attended once weekly, 75-min classes (12 total classes), which included information on RLS and other sleep disorders, RLS management including sleep hygiene practices, and complementary therapies. Feasibility and acceptability outcomes included program satisfaction and recruitment, retention, and adherence rates. In addition, participants were asked their preferences regarding three yoga class schedule scenarios for a future study. Attendance, yoga, and treatment logs were collected weekly. Program evaluation and yoga scheduling questionnaires were collected at week 12. Results: Forty-one adults with moderate to severe RLS were randomized to a 12-week yoga (n = 19) or educational film (n = 22) program. Thirty participants (73%) completed the program. Yoga and education group participants attended an average of 13.0 ± 0.84 (81%) and 10.3 ± 0.3 classes (85%), respectively. Participants from both groups indicated satisfaction with the study. All yoga group respondents to the program evaluation reported they would likely (n = 6) or very likely (n = 7) continue yoga practice; 86.7% of education group respondents (13 of 15) indicated that they were likely (n = 7) or very likely (n = 6) to make lasting changes based on what they had learned. The preferred schedule for a future study was a 16-week study with once-weekly yoga classes. Conclusions: The findings of this study suggest that a larger RCT comparing yoga with an educational film group for the management of RLS is feasible. Trial registration: Clinicaltrials.gov: NCT03570515; 02/01/2017.

Incorporating a Usual Care Comparator into a Study of Meditation and Music Listening for Older Adults with Subjective Cognitive Decline: A Randomized Feasibility Trial.

BACKGROUND: Recent studies suggest meditation and music listening (ML) may improve cognitive and psychosocial outcomes in adults with subjective cognitive decline (SCD). However, lack of a usual care group has limited conclusions. OBJECTIVE: To assess the: 1) feasibility of incorporating an enhanced usual care (EUC) comparator in a trial of Kirtan Kriya meditation (KK) and ML for adults experiencing SCD; and 2) preliminary effects of active treatment (KK/ML) versus an EUC program. METHODS: Forty participants with SCD were randomized 1:1:2 to a 12-week KK, ML, or EUC program. KK and ML participants were asked to practice 12 minutes/day; EUC participants were given a comprehensive educational packet regarding healthy aging and strategies for improving/maintaining brain health and asked to record any activities or strategies used. Feasibility was assessed using measures of retention, adherence, treatment expectancies, and participant satisfaction, as well as information from exit questionnaires and daily practice/activity logs. Cognitive functioning, stress, mood, sleep-quality, and health-related quality of life (QOL) were measured pre- and post-intervention using well-validated instruments. RESULTS: Thirty-two participants (80%) completed the 3-month study, with retention highest in the EUC group (p < 0.05). Active treatment participants averaged 6.0±0.4 practice sessions/week, and EUC participants, 7.5±0.6 brain health activities/week. Treatment expectancies were similar across groups. EUC participants indicated high satisfaction with the program and study. Despite limited study power, the active treatment group showed significantly greater gains in subjective memory functioning (ps≤0.025) and nonsignificant improvements in cognitive performance (TMT-B), perceived stress, QOL, and mood (ps≤0.08) compared to the EUC group. CONCLUSION: Findings of this pilot feasibility trial suggest incorporation of an EUC program is feasible, and that participation in a simple 12-week relaxation program may be helpful for adults with SCD versus engagement in an EUC program.

Electrophysiological Evidence of Early Cortical Sensitivity to Human Conspecific Mimic Voice as a Distinct Category of Natural Sound.

Purpose From an anthropological perspective of hominin communication, the human auditory system likely evolved to enable special sensitivity to sounds produced by the vocal tracts of human conspecifics whether attended or passively heard. While numerous electrophysiological studies have used stereotypical human-produced verbal (speech voice and singing voice) and nonverbal vocalizations to identify human voice-sensitive responses, controversy remains as to when (and where) processing of acoustic signal attributes characteristic of "human voiceness" per se initiate in the brain. Method To explore this, we used animal vocalizations and human-mimicked versions of those calls ("mimic voice") to examine late auditory evoked potential responses in humans. Results Here, we revealed an N1b component (96-120 ms poststimulus) during a nonattending listening condition showing significantly greater magnitude in response to mimics, beginning as early as primary auditory cortices, preceding the time window reported in previous studies that revealed species-specific vocalization processing initiating in the range of 147-219 ms. During a sound discrimination task, a P600 (500-700 ms poststimulus) component showed specificity for accurate discrimination of human mimic voice. Distinct acoustic signal attributes and features of the stimuli were used in a classifier model, which could distinguish most human from animal voice comparably to behavioral data-though none of these single features could adequately distinguish human voiceness. Conclusions These results provide novel ideas for algorithms used in neuromimetic hearing aids, as well as direct electrophysiological support for a neurocognitive model of natural sound processing that informs both neurodevelopmental and anthropological models regarding the establishment of auditory communication systems in humans. Supplemental Material https://doi.org/10.23641/asha.12903839.

Effects of a 12-week yoga versus a 12-week educational film intervention on symptoms of restless legs syndrome and related outcomes: an exploratory randomized controlled trial.

STUDY OBJECTIVES: To assess the effects of a yoga versus educational film (EF) program on restless legs syndrome (RLS) symptoms and related outcomes in adults with RLS. METHODS: Forty-one community-dwelling, ambulatory nonpregnant adults with moderate to severe RLS were randomized to a 12-week yoga (n = 19) or EF program (n = 22). In addition to attending classes, all participants completed practice/treatment logs. Yoga group participants were asked to practice at home 30 minutes per day on nonclass days; EF participants were instructed to record any RLS treatments used on their daily logs. Core outcomes assessed pretreatment and posttreatment were RLS symptoms and symptom severity (International RLS Study Group Scale (IRLS) and RLS ordinal scale), sleep quality, mood, perceived stress, and quality of life (QOL). RESULTS: Thirty adults (13 yoga, 17 EF), aged 24 to 73 (mean = 50.4 ± 2.4 years), completed the 12-week study (78% female, 80.5% white). Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04). Relative to the EF group, yoga participants demonstrated significantly greater reductions in RLS symptoms and symptom severity (P ≤ .01), and greater improvements in perceived stress and mood (P ≤ .04), as well as sleep quality (P = .09); RLS symptoms decreased to minimal/mild in 77% of yoga group participants, with none scoring in the severe range by week 12, versus 24% and 12%, respectively, in EF participants. In the yoga group, IRLS and RLS severity scores declined with increasing minutes of homework practice (r = .7, P = .009 and r = .6, P = .03, respectively), suggesting a possible dose-response relationship. CONCLUSIONS: Findings of this exploratory RCT suggest that yoga may be effective in reducing RLS symptoms and symptom severity, decreasing perceived stress, and improving mood and sleep in adults with RLS. CLINICAL TRIAL REGISTRATION: Registry: Clinicaltrials.gov; Title: Yoga vs. Education for Restless Legs: a Feasibility Study; Identifier: NCT03570515; URL: https://clinicaltrials.gov/ct2/show/NCT03570515.

Processing of Real-World, Dynamic Natural Stimuli in Autism is Linked to Corticobasal Function.

Many individuals with autism spectrum disorder (ASD) have been shown to perceive everyday sensory information differently compared to peers without autism. Research examining these sensory differences has primarily utilized nonnatural stimuli or natural stimuli using static photos with few having utilized dynamic, real-world nonverbal stimuli. Therefore, in this study, we used functional magnetic resonance imaging to characterize brain activation of individuals with high-functioning autism when viewing and listening to a video of a real-world scene (a person bouncing a ball) and anticipating the bounce. We investigated both multisensory and unisensory processing and hypothesized that individuals with ASD would show differential activation in (a) primary auditory and visual sensory cortical and association areas, and in (b) cortical and subcortical regions where auditory and visual information is integrated (e.g. temporal-parietal junction, pulvinar, superior colliculus). Contrary to our hypotheses, the whole-brain analysis revealed similar activation between the groups in these brain regions. However, compared to controls the ASD group showed significant hypoactivation in the left intraparietal sulcus and left putamen/globus pallidus. We theorize that this hypoactivation reflected underconnectivity for mediating spatiotemporal processing of the visual biological motion stimuli with the task demands of anticipating the timing of the bounce event. The paradigm thus may have tapped into a specific left-lateralized aberrant corticobasal circuit or loop involved in initiating or inhibiting motor responses. This was consistent with a dual "when versus where" psychophysical model of corticobasal function, which may reflect core differences in sensory processing of real-world, nonverbal natural stimuli in ASD. Autism Res 2020, 13: 539-549. © 2020 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: To understand how individuals with autism perceive the real-world, using magnetic resonance imaging we examined brain activation in individuals with autism while watching a video of someone bouncing a basketball. Those with autism had similar activation to controls in auditory and visual sensory brain regions, but less activation in an area that processes information about body movements and in a region involved in modulating movements. These areas are important for understanding the actions of others and developing social skills.

Acceptability and feasibility of a 12-week yoga vs. educational film program for the management of restless legs syndrome (RLS): study protocol for a randomized controlled trial.

BACKGROUND: Restless legs syndrome (RLS) is a common and burdensome sleep disorder associated with profound impairment of health, well-being, and quality of life. Unfortunately, the medications used for RLS management carry risk of serious side effects, including augmentation of symptoms. Yoga, an ancient mind-body discipline designed to promote physical, emotional, and mental well-being, may offer a viable, low-risk new treatment. The primary objectives of this pilot, parallel-arm, randomized controlled trial (RCT) are to assess the acceptability and feasibility of a 12-week yoga vs. educational film program for the management of RLS. METHODS: Forty-four adults with confirmed moderate to severe RLS will be recruited and randomized to a 12-week yoga (n = 22) or standardized educational film program (N = 22). Yoga group participants will attend two 75-min Iyengar yoga classes per week for the first 4 weeks, then one 75-min class per week for the remaining 8 weeks, and will complete a 30-min homework routine on non-class days. Educational film group participants will attend one 75-min class per week for 12 weeks and complete a daily RLS treatment log; classes will include information on: RLS management, including sleep hygiene practices; other sleep disorders; and complementary therapies likely to be of interest to those participating in a yoga and sleep education study. Yoga and treatment logs will be collected weekly. Feasibility outcomes will include recruitment, enrollment, and randomization rates, retention, adherence, and program satisfaction. Program evaluation and yoga-dosing questionnaires will be collected at week 12; data on exploratory outcomes (e.g., RLS symptom severity (IRLS), sleep quality (PSQI), mood (POMS, PSS), and health-related quality of life (SF-36)) will be gathered at baseline and week 12. DISCUSSION: This study will lay the essential groundwork for a planned larger RCT to determine the efficacy of a yoga program for reducing symptoms and associated burden of RLS. If the findings of the current trial and the subsequent larger RCTs are positive, this study will also help support a new approach to clinical treatment of this challenging disorder, help foster improved understanding of RLS etiology, and ultimately contribute to reducing the individual, societal, and economic burden associated with this condition. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03570515 . Retrospectively registered on 1 February 2017.

Effects of Meditation and Music-Listening on Blood Biomarkers of Cellular Aging and Alzheimer's Disease in Adults with Subjective Cognitive Decline: An Exploratory Randomized Clinical Trial.

BACKGROUND: Telomere length (TL), telomerase activity (TA), and plasma amyloid-ß (Aß) levels have emerged as possible predictors of cognitive decline and dementia. OBJECTIVE: To assess the: 1) effects of two 12-week relaxation programs on TL, TA, and Aß levels in adults with subjective cognitive decline; and 2) relationship of biomarker changes to those in cognitive function, psychosocial status, and quality of life (QOL). METHODS: Participants were randomized to a 12-week Kirtan Kriya meditation (KK) or music listening (ML) program and asked to practice 12 minutes/day. Plasma Aß(38/40/42) and peripheral blood mononuclear cell TL and TA were measured at baseline and 3 months. Cognition, stress, sleep, mood, and QOL were assessed at baseline, 3 months, and 6 months. RESULTS: Baseline blood samples were available for 53 participants (25 KK, 28 ML). The KK group showed significantly greater increases in Aß40 than the ML group. TA rose in both groups, although increases were significant only among those with higher practice adherence and lower baseline TA. Changes in both TL and TA varied by their baseline values, with greater increases among participants with values ≤50th percentile (ps-interaction <0.006). Both groups improved in cognitive and psychosocial status (ps ≤0.05), with improvements in stress, mood, and QOL greater in the KK group. Rising Aß levels were correlated with gains in cognitive function, mood, sleep, and QOL at both 3 and 6 months, associations that were particularly pronounced in the KK group. Increases in TL and TA were also correlated with improvements in certain cognitive and psychosocial measures. CONCLUSION: Practice of simple mind-body therapies may alter plasma Aß levels, TL, and TA. Biomarker increases were associated with improvements in cognitive function, sleep, mood, and QOL, suggesting potential functional relationships.

Effects of Mantra Meditation versus Music Listening on Knee Pain, Function, and Related Outcomes in Older Adults with Knee Osteoarthritis: An Exploratory Randomized Clinical Trial (RCT).

OBJECTIVE: Disease-modifying treatments for OA remain elusive, and commonly used medications can have serious side effects. Although meditation and music listening (ML) have been shown to improve outcomes in certain chronic pain populations, research in OA is sparse. In this pilot RCT, we explore the effects of two mind-body practices, mantra meditation (MM) and ML, on knee pain, function, and related outcomes in adults with knee OA. METHODS: Twenty-two older ambulatory adults diagnosed with knee OA were randomized to a MM (N=11) or ML program (N=11) and asked to practice 15-20 minutes, twice daily for 8 weeks. Core outcomes included knee pain (Knee Injury and Osteoarthritis Outcome Score [KOOS] and Numeric Rating Scale), knee function (KOOS), and perceived OA severity (Patient Global Assessment). Additional outcomes included perceived stress (Perceived Stress Scale), mood (Profile of Mood States), sleep (Pittsburgh Sleep Quality Index), and health-related quality of life (QOL, SF-36). Participants were assessed at baseline and following completion of the program. RESULTS: Twenty participants (91%) completed the study (9 MM, 11 ML). Compliance was excellent; participants completed an average of 12.1±0.83 sessions/week. Relative to baseline, participants in both groups demonstrated improvement post-intervention in all core outcomes, including knee pain, function, and perceived OA severity, as well as improvement in mood, perceived stress, and QOL (Physical Health) (p's≤0.05). Relative to ML, the MM group showed greater improvements in overall mood and sleep (p's≤0.04), QOL-Mental Health (p<0.07), kinesiophobia (p=0.09), and two domains of the KOOS (p's<0.09). CONCLUSIONS: Findings of this exploratory RCT suggest that a simple MM and, possibly, ML program may be effective in reducing knee pain and dysfunction, decreasing stress, and improving mood, sleep, and QOL in adults with knee OA.

Assessing the impact of a targeted electronic medical record intervention on the use of growth factor in cancer patients.

BACKGROUND: Patients receiving chemotherapy are at risk for febrile neutropenia following treatment. The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) recommend screening patients for risk of febrile neutropenia and risk stratification based on likelihood of febrile neutropenia events. The impact of the implementation of an electronic medical record (EMR) system on physician compliance with growth factor support guidelines has not been studied. OBJECTIVE: To investigate whether implementation of automated orders in EMRs can improve adherence to national guidelines in prophylactic G-CSF use in chemotherapy patients. METHODS: A retrospective chart review of cancer patients receiving chemotherapy from January 1, 2007 to August 1, 2008 (pre- EMR) and January 1, 2011 to December 31, 2011 (post-EMR) was conducted. Institutional adherence to ASCO and NCCN guidelines for G-CSF after the implementation of automatic electronic orders for pegfilgrastim in patients who received a high-risk chemotherapy regimen were examined. The results were compared with a similar study that had been conducted before the implementation of the EMR system. RESULTS: The number of regimens that included guideline-driven growth factor usage and nonusage was 75.6% in the post-intervention arm, compared with 67.5% in the pre-intervention arm. This is a statistically significant difference between the pre-EMR and post-EMR compliance with national guidelines on growth factor usage ( P = .041, based on chi-square test). The post-EMR implementation data of 1,042 individual new chemotherapy regimens showed correct use of G-CSF in 89.13% high-risk chemotherapy regimens and 58.74% intermediate-risk regimens, with risk factors and incorrect usage in 26.23% of intermediate-risk regimens without risk factors and 19.34% of low-risk regimens. The appropriateness of use in high- and low-risk regimens was the most compliant, because growth factor was built into chemotherapy plans of high-risk regimens and omitted from low-risk regimens. LIMITATIONS: This project was limited by a change in EMR systems at West Virginia University hospitals on January 1, 2009. All pre- EMR data was collected before 2009 and could not be further collected once the project began in 2013. CONCLUSIONS: Appropriateness of growth factor usage can be improved when integrated into an EMR. This can improve compliance and adherence to national recommendations. Further development and understanding of EMR is needed to improve usage to meet national guidelines, with particular attention paid to integration of risk factors into EMR to improve growth factor usage compliance.

A phase II, randomized, double blind trial of calcium aluminosilicate clay versus placebo for the prevention of diarrhea in patients with metastatic colorectal cancer treated with irinotecan.

PURPOSE: Calcium aluminosilicate clay (CASAD) is a naturally occurring clay that serves as a cation exchange absorbent. We hypothesized that oral administration of CASAD would reduce the rate of grade 3/4 diarrhea associated with irinotecan use for metastatic colorectal cancer (CRC) by adsorbing the SN-38 metabolite. METHODS: Patients receiving irinotecan-based chemotherapy were randomized equally between CASAD and placebo arms in this multicenter trial in order to assess differences in the proportions of patients with grade 3/4 diarrhea within 6 weeks. Additionally, we compared symptom severity between the two arms using the M.D. Anderson Symptom Inventory. RESULTS: Between May 2009 and May 2012, 100 patients were enrolled. In evaluable patients, 7 of 43 (16 %) on the CASAD arm compared to 3 of 32 (9 %) on the placebo arm experienced grade 3/4 diarrhea (P = 0.70). The rate of any diarrhea among all patients was similar (CASAD arm, 64 % vs. placebo arm, 70 %). The rate of study dropout was 14 % in the CASAD arm and 38 % in the placebo arm (P = 0.01). No differences were found in symptom severity, individual symptom items, and in serious adverse events between the two arms. CONCLUSION: Compared to placebo, CASAD use was safe but ineffective in preventing diarrhea in metastatic CRC patients treated with irinotecan-containing chemotherapy regimens. There were no distinct signals in terms of patient symptoms between arms, but there was significantly more patient dropout in the placebo arm. Future CASAD trials will focus on the active treatment of diarrhea.

Multimodality management of urachal carcinoma: the M. D. Anderson Cancer Center experience.

PURPOSE: Enteric type adenocarcinomas arising in the dome of the bladder or along the urachal ligament are uncommon. To improve our understanding of urachal carcinoma and define outcome with current management, we performed a retrospective review of cases seen at the M. D. Anderson Cancer Center. MATERIALS AND METHODS: We reviewed the records of 42 patients with urachal carcinoma evaluated at our institution from 1985 to 2001. Specifically, we sought to evaluate the importance of extent of disease, surgical characteristics and systemic therapy on clinical outcome. RESULTS: Of the 42 patients 7 had clinically evident metastases at diagnosis and 35 had resectable disease that was managed initially with surgery. Overall survival from diagnosis for all 42 patients was 46 months with 40% surviving at 5 years. Of the resected cases 16 (46%) remain disease-free (median followup 31 months). Covariates associated with long-term survival were negative surgical margins (p = 0.004) and absence of nodal involvement (p = 0.01). Median survival from recognition of metastatic disease was 24 months in 26 patients in whom metastases ultimately developed. Chemotherapy for metastatic disease produced only 4 significant responses, including 3 of 9 patients treated with 5-fluorouracil and cisplatin containing regimens. CONCLUSIONS: Urachal carcinomas are usually locally advanced at presentation with a high risk of distant metastases. However, long-term survival following radical resection occurs in a significant fraction of patients (16 of 35 in our series), supporting an attempt at margin-negative, en bloc resection if at all possible. Chemotherapy appropriate for enteric type adenocarcinoma can induce objective responses but meaningful improvement in survival is not yet demonstrated.