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Progressive resistance exercise training (PRT) is the most effective known intervention for combating aging skeletal muscle atrophy. However, the hypertrophic response to PRT is variable, and this may be due to muscle inflammation susceptibility. Metformin reduces inflammation, so we hypothesized that metformin would augment the muscle response to PRT in healthy women and men aged 65 and older. In a randomized, double‐blind trial, participants received 1,700 mg/day metformin (N = 46) or placebo (N = 48) throughout the study, and all subjects performed 14 weeks of supervised PRT. Although responses to PRT varied, placebo gained more lean body mass (p = .003) and thigh muscle mass (p < .001) than metformin. CT scan showed that increases in thigh muscle area (p = .005) and density (p = .020) were greater in placebo versus metformin. There was a trend for blunted strength gains in metformin that did not reach statistical significance. Analyses of vastus lateralis muscle biopsies showed that metformin did not affect fiber hypertrophy, or increases in satellite cell or macrophage abundance with PRT. However, placebo had decreased type I fiber percentage while metformin did not (p = .007). Metformin led to an increase in AMPK signaling, and a trend for blunted increases in mTORC1 signaling in response to PRT. These results underscore the benefits of PRT in older adults, but metformin negatively impacts the hypertrophic response to resistance training in healthy older individuals. ClinicalTrials.gov Identifier: NCT02308228. Because metformin reduces inflammation, we hypothesized that it would augment the muscle response to progressive resistance exercise training (PRT) in healthy older participants. Following 14 weeks of PRT, metformin blunted gains in lean mass, thigh muscle mass, and thigh muscle density compared to placebo. Metformin did not affect increases in muscle macrophage abundance. However, metformin increased AMPK signaling, leading to a reduced mean increase in mTOR signaling.

Diabetic retinopathy (DR) is the leading cause of incident blindness among working-age adults in the United States. Federally designated safety-net clinics (FDSC) often serve as point-of-contact for patients least likely to receive recommended DR screenings, creating opportunity for targeted interventions to increase screening access and compliance. With such a goal, we implemented and assessed the longitudinal performance of an FDSC-based telemedicine DR screening (TDRS) network of 22 clinical sites providing nonmydriatic fundus photography with remote interpretation and reporting. Retrospective analysis of patient encounters between February 2014 and January 2019 was performed to assess rates of pathology and referral. A generalized estimating equation logistic regression model was used for subset analysis from audits of pre- and post-implementation screening rates. Finally, patient surveys were conducted and assessed as a measure of intervention acceptability. Of the 13,923 individual telescreening encounters (4327 female, 4220 male, and 5376 unspecified; mean [SD] age, 54.9 [12.5] years) studied, 10,540 were of adequate quality to identify 3532 (33.5%) patients with ocular pathology: 2319 (22.0%) patients had some level of DR with 1604 (15.2%) requiring specialist referral, and 808 (7.7%) patients required referral for other ocular pathologies. The mean screening rate for audited clinics in the year prior to program implementation was 29.9% (641/2147), which increased to 47.7% (1012/2124) in the program's first year, doubling patients' odds of being screened (OR 2.2; 95% CI: 1.3-3.7; P = .003). These gains were sustained over four years following implementation (OR 1.9; 95% CI: 1.1-3.1; P = .018) despite varied clinic screening performance (4-year averaged range, 22.9-55.1%). Odds of early detection likewise doubled for patients with consecutive screenings (OR 2.2, 95% CI: 2.0-2.4; P < .001). Finally, surveyed patients preferred TDRS to specialist exams (82.5%; 776/941) and would recommend the service to friends (92.7%; 868/936). A statewide, FDSC-centered TDRS network was successfully established and sustained in a medically underserved region of the United States. Our results suggest that large TDRS networks in FDSCs can increase screening access and compliance for otherwise unscreened populations, but outcomes can vary greatly among clinics. Further work to optimize program implementation is needed to maximize this model's impact.

Although ankle sprains have the highest recurrence rate of any musculoskeletal injury, objective estimates of when an athlete is likely to return-to-play (RTP) are unknown. The purpose was to compare time to return-to-play probability timelines for new and recurrent ankle sprains in interscholastic athletes. Observational. Ankle sprain data were collected at seven high schools during the 2007–2008 and 2008–2009 academic years. Ankle sprains were categorized by time lost from participation (same day return, next-day return, 3-day return, 7-day return, 10-day return, >22-day return, no return [censored data]). Time-to-event analyses were used to determine the influence of ankle injury history on return-to-play after an ankle sprain. 204 ankle sprains occurred during 479,668 athlete-exposures, 163 were new (4 censored) and 35 recurrent (1 censored). There was no significant difference (p=0.89) between the time-to-event curves for new and recurrent ankle sprains. The median (inter-quartile rage) time to return-to-play for new sprains (inter-quartile range)=3 days (same day to 7 day return); recurrent sprains=next day return (next day to 7 day return). Noteworthy probabilities [95% CIs] include: same day return (new=25.2[18.7, 31.9], recurrent=17.1[6.6, 30.3]); next-day return (new=43.6[35.3, 52.7], recurrent=51.4[32.5, 67.5]); and 7-day return (new=85.9[73.8, 94.4], recurrent=94.3[47.8, 99.5]). Previous injury history did not affect time until return-to-play probabilities for ankle sprains. Time until return-to-play analyses that describe the likelihood of return-to-play are useful to clinicians by providing prognostic guidelines and can be used for educating athletes, coaches, and parents about the likely timeframe of being withheld from play.

Background Muscle mass and strength are strong determinants of a person’s quality of life and functional independence with advancing age. While resistance training is the most effective intervention to combat age-associated muscle atrophy (sarcopenia), the ability of older adults to increase muscle mass and strength in response to training is blunted and highly variable. Thus, finding novel ways to complement resistance training to improve muscle response and ultimately quality of life among older individuals is critical. The purpose of this study is to determine whether a commonly prescribed medication called metformin can be repurposed to improve the response to resistance exercise training by altering the muscle tissue inflammatory environment. Methods/design Individuals aged 65 and older are participating in a two-site, randomized, double-blind, placebo-controlled trial testing the effects of metformin or placebo on muscle size, strength, and physical function when combined with a progressive resistance training program. Participants consume 1700 mg of metformin per day or placebo for 2 weeks before engaging in a 14-week progressive resistance training regimen, with continued metformin or placebo. Participants are then monitored post-training to determine if the group taking metformin derived greater overall benefit from training in terms of muscle mass and strength gains than those on placebo. Muscle biopsies are taken from the vastus lateralis at three time points to assess individual cellular and molecular adaptations to resistance training and also changes in response to metformin. Discussion The response of aged muscles to a resistance training program does not always result in a positive outcome; some individuals even experience a loss in muscle mass following resistance training. Thus, adjuvant therapies, including pharmacological ones, are required to optimize response to training in those who do not respond and may be at increased risk of frailty. This is the first known metformin repurposing trial in non-diseased individuals, aimed specifically at the resistance exercise “non-responder” phenotype present in the aging population. The overall goal of this trial is to determine if combined exercise-metformin intervention therapy will benefit older individuals by promoting muscle hypertrophy and strength gains, thereby maintaining functional independence. Trial registration ClinicalTrials.gov, NCT02308228 . Registered on 25 November 2014.

Circadian rhythms differ between young adult males and females. For example, males tend to be later chronotypes, preferring later timing of sleep and activity, than females. Likewise, there are sex differences in body composition and cardiorespiratory fitness. Few studies have investigated the association between circadian rhythms, cardiorespiratory fitness, and body composition. We sought to determine whether chronotype and circadian phase were associated with cardiorespiratory fitness, body composition, and anthropometric measures in sedentary males and females. Fifty‐nine adults participated in the study. Circadian phase and chronotype were measured using dim light melatonin onset (DLMO) and the Morningness–Eveningness Questionnaire (MEQ) score. We used peak oxygen uptake (VO2peak) results from a maximal graded exercise test to assess cardiorespiratory fitness. Body composition, BMI, and circumferences were collected as markers of adiposity. We observed a sex difference in the association between DLMO and VO2peak. For males, a later DLMO was associated with a lower VO2peak. VO2peak did not vary based on DLMO in females. Later circadian phase was also associated with increased body fat percentage, fat mass index, and abdominal circumference in males, but not females. Collectively, these results suggest that males who are later chronotypes may be at risk of obesity and low cardiorespiratory fitness.

Context: Fewer athletic injuries and lower anterior cruciate ligament injury incidence rates were noted in studies of neuromuscular-training (NMT) interventions that had high compliance rates. However, several groups have demonstrated that preventive NMT interventions were limited by low compliance rates. Objective: To descriptively analyze coach and athlete compliance with preventive NMT and compare the compliance between study arms as well as among school levels and sports. Design: Randomized, controlled clinical trial. Setting: Middle and high school athletic programs. Participants or Other Participants: A total of 52 teams, comprising 547 female athletes, were randomly assigned to the experimental or control group and followed for 1 athletic season. Intervention(s): The experimental group (n = 30 teams [301 athletes]: 12 basketball teams [125 athletes], 6 soccer teams [74 athletes], and 12 volleyball teams [102 athletes]) participated in an NMT program aimed at reducing traumatic knee injuries through a trunk-stabilization and hip-strengthening program. The control group (n = 22 teams [246 athletes]: 11 basketball teams [116 athletes], 5 soccer teams [68 athletes], and 6 volleyball teams [62 athletes]) performed a resistive rubber-band running program. Main Outcome Measure(s): Compliance with the assigned intervention protocols (3 times per week during the preseason [mean = 3.4 weeks] and 2 times per week in-season [mean = 11.9 weeks] of coaches [coach compliance] and athletes [athlete compliance]) was measured descriptively. Using an independent t test, we compared coach and athlete compliance between the study arms. A 2-way analysis of variance was calculated to compare differences between coach and athlete compliance by school level (middle and high schools) and sport (basketball, soccer, and volleyball). Results: The protocols were completed at a mean rate of 1.3 ± 1.1 times per week during the preseason and 1.2 ± 0.5 times per week in-season. A total of 88.4% of athletes completed 2/3 of the intervention sessions. Coach compliance was greater in the experimental group than in the control group (P = .014). Coach compliance did not differ by sport but was greater at the high school than the middle school (P = .001) level. Athlete compliance did not differ by study arm, sport, or school level. Conclusions: Athletes received instruction in about 50% of each protocol. Nearly 90% of athletes performed more than 2/3 of the assigned NMT interventions. The assigned intervention was performed more often in the experimental arm compared with the control arm. Coaches at the high school level complied with the given protocol more than middle school coaches did. Athletes complied well with the protocol, but coaches did not, especially at the middle school level.

Underage drinking and related risky sexual behavior (RSB) are major public health concerns on United States college campuses. Although technology-delivered personalized feedback interventions (PFIs) are considered a best practice for individual-level campus alcohol prevention, there is room for improving the effectiveness of this approach with regard to alcohol-related RSB. The aims of this study are to (1) evaluate the impact of a brief PFI that integrates content on alcohol use and RSB and is adapted to include a novel cross-tailored dynamic feedback (CDF) component for at-risk first-year college students and (2) identify implementation factors critical to the CDF's success to facilitate future scale-up in campus settings. This study uses a hybrid type 1 effectiveness-implementation design and will be conducted in 3 phases. Phase 1 is a stakeholder-engaged PFI+CDF adaptation guided by focus groups and usability testing. In phase 2, 600 first-year college students who drink and are sexually active will be recruited from 2 sites (n=300 per site) to participate in a 4-group randomized controlled trial to examine the effectiveness of PFI+CDF in reducing alcohol-related RSB. Eligible participants will complete a baseline survey during the first week of the semester and follow-up surveys at 1, 2, 3, 6, and 13 months post baseline. Phase 3 is a qualitative evaluation with stakeholders to better understand relevant implementation factors. Recruitment and enrollment for phase 1 began in January 2022. Recruitment for phases 2 and 3 is planned for the summer of 2023 and 2024, respectively. Upon collection of data, the effectiveness of PFI+CDF will be examined, and factors critical to implementation will be evaluated. This hybrid type 1 trial is designed to impact the field by testing an innovative adaptation that extends evidence-based alcohol programs to reduce alcohol-related RSB and provides insights related to implementation to bridge the gap between research and practice at the university level. ClinicalTrials.gov NCT05011903; https://clinicaltrials.gov/ct2/show/NCT05011903. DERR1-10.2196/43986.

Bystander interventions have been highlighted as promising strategies to reduce sexual violence and sexual harassment, yet their effectiveness for sexual minority youth remains largely unexamined in high schools’ populations. This rigorous cluster randomized control trial addresses this gap by evaluating intervention effectiveness among sexual majority and minority students known be to at increased risk of sexual violence. Kentucky high schools were randomized to intervention or control conditions. In intervention schools, educators provided school-wide Green Dot presentations (phase 1) and intensive bystander training to student popular opinion leaders (phase 2). Each spring from 2010 to 2014, students attending 26 high schools completed anonymous surveys about violence acceptance and violent events. An analytic sample of 74,836 surveys with no missing data over the 5 years was available. Sexual violence acceptance scores declined significantly over time in intervention versus control schools among all but sexual minority males. This intervention was also associated with reductions in both perpetration and victimization of sexual violence, sexual harassment, and physical dating violence among sexual majority yet not sexual minority youth. Both sexual minority and majority youth experienced reductions in stalking victimization and perpetration associated with the intervention. In this large cluster randomized controlled trial, the bystander intervention appears to work best to reduce violence for sexual majority youth. Bystander programs may benefit from explicitly engaging sexual minority youth in intervention efforts or adapting intervention programs to include attitudes that shape the experience of sexual minority high school youth (e.g., homophobic teasing, homonegativity).

Purpose This study aims to evaluate the incidence and prevalence of temporomandibular disorders (TMD) in patients receiving a mandibular advancement device (MAD) to treat obstructive sleep apnea using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). In addition, it also aims to assess the development of posterior open bite (POB). Materials and methods Data from 167 patients were evaluated at baseline, from 159 patients after 118 days (visit II), from 129 patients after 208 days (visit III), and from 85 patients after 413 days (visit IV). The presence of TMD symptoms was evaluated through a questionnaire. TMD signs were assessed using the RDC/TMD. Clinical evaluation assessed for the presence of POB . Results The prevalence of TMD was 33/167 (19.8 %) at baseline. After an initial decrease to 14.5 % on visit II, the prevalence increased to 19.4 % on visit III and finally demonstrated a decrease to 8.2 % on visit IV. The incidence of TMD was 10.6 % on visit II. This decreased on further visits and only two (1.9 %) patients developed TMD from visit III to visit IV. POB was found to develop with an average incidence of 6.1 % per visit. The prevalence of POB was 5.8 % on visit II, 9.4 % on visit III, and 17.9 % on visit IV. Conclusion The use of MADs may lead to the development of TMD in a small number of patients. Nevertheless, these signs are most likely transient. Patients with pre-existing signs and symptoms of TMD do not experience significant exacerbation of those signs and symptoms with MAD use. Furthermore, these may actually decrease over time. POB was found to develop in 17.9 % of patients; however, only 28.6 % of these patients were aware of any bite changes.

The availability of large healthcare datasets offers the opportunity for researchers to navigate the traditional clinical and translational science research stages in a nonlinear manner. In particular, data scientists can harness the power of large healthcare datasets to bridge from preclinical discoveries (T0) directly to assessing population-level health impact (T4). A successful bridge from T0 to T4 does not bypass the other stages entirely; rather, effective team science makes a direct progression from T0 to T4 impactful by incorporating the perspectives of researchers from every stage of the clinical and translational science research spectrum. In this exemplar, we demonstrate how effective team science overcame challenges and, ultimately, ensured success when a diverse team of researchers worked together, using healthcare big data to test population-level substance use disorder (SUD) hypotheses generated from preclinical rodent studies. This project, called Advancing Substance use disorder Knowledge using Big Data (ASK Big Data), highlights the critical roles that data science expertise and effective team science play in quickly translating preclinical research into public health impact.