Testosterone Treatment and Fractures in Men with Hypogonadism.

BACKGROUND: Testosterone treatment in men with hypogonadism improves bone density and quality, but trials with a sufficiently large sample and a sufficiently long duration to determine the effect of testosterone on the incidence of fractures are needed. METHODS: In a subtrial of a double-blind, randomized, placebo-controlled trial that assessed the cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism, we examined the risk of clinical fracture in a time-to-event analysis. Eligible men were 45 to 80 years of age with preexisting, or high risk of, cardiovascular disease; one or more symptoms of hypogonadism; and two morning testosterone concentrations of less than 300 ng per deciliter (10.4 nmol per liter), in fasting plasma samples obtained at least 48 hours apart. Participants were randomly assigned to apply a testosterone or placebo gel daily. At every visit, participants were asked if they had had a fracture since the previous visit. If they had, medical records were obtained and adjudicated. RESULTS: The full-analysis population included 5204 participants (2601 in the testosterone group and 2603 in the placebo group). After a median follow-up of 3.19 years, a clinical fracture had occurred in 91 participants (3.50%) in the testosterone group and 64 participants (2.46%) in the placebo group (hazard ratio, 1.43; 95% confidence interval, 1.04 to 1.97). The fracture incidence also appeared to be higher in the testosterone group for all other fracture end points. CONCLUSIONS: Among middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo. The fracture incidence was numerically higher among men who received testosterone than among those who received placebo. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).

Cardiovascular Safety of Testosterone-Replacement Therapy.

BACKGROUND: The cardiovascular safety of testosterone-replacement therapy in middle-aged and older men with hypogonadism has not been determined. METHODS: In a multicenter, randomized, double-blind, placebo-controlled, noninferiority trial, we enrolled 5246 men 45 to 80 years of age who had preexisting or a high risk of cardiovascular disease and who reported symptoms of hypogonadism and had two fasting testosterone levels of less than 300 ng per deciliter. Patients were randomly assigned to receive daily transdermal 1.62% testosterone gel (dose adjusted to maintain testosterone levels between 350 and 750 ng per deciliter) or placebo gel. The primary cardiovascular safety end point was the first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, assessed in a time-to-event analysis. A secondary cardiovascular end point was the first occurrence of any component of the composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, assessed in a time-to-event analysis. Noninferiority required an upper limit of less than 1.5 for the 95% confidence interval of the hazard ratio among patients receiving at least one dose of testosterone or placebo. RESULTS: The mean (±SD) duration of treatment was 21.7±14.1 months, and the mean follow-up was 33.0±12.1 months. A primary cardiovascular end-point event occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.78 to 1.17; P<0.001 for noninferiority). Similar findings were observed in sensitivity analyses in which data on events were censored at various times after discontinuation of testosterone or placebo. The incidence of secondary end-point events or of each of the events of the composite primary cardiovascular end point appeared to be similar in the two groups. A higher incidence of atrial fibrillation, of acute kidney injury, and of pulmonary embolism was observed in the testosterone group. CONCLUSIONS: In men with hypogonadism and preexisting or a high risk of cardiovascular disease, testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).

Medical Directors, Facilities, and Finances: Resource Deficiencies in Accredited Paramedic Programs.

BACKGROUND: Initial paramedic education must have sufficient rigor and appropriate resources to prepare graduates to provide lifesaving prehospital care. Despite required national paramedic accreditation, there is substantial variability in paramedic pass rates that may be related to program infrastructure and clinical support. Our objective was to evaluate US paramedic program resources and identify common deficiencies that may affect program completion. METHODS: We conducted a cross-sectional mixed methods analysis of the 2018 Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions annual report, focusing on program Resource Assessment Matrices (RAM). The RAM is a 360-degree evaluation completed by program personnel, advisory committee members, and currently enrolled students to identify program resource deficiencies affecting educational delivery. The analysis included all paramedic programs that reported graduating students in 2018. Resource deficiencies were categorized into ten categories: faculty, medical director, support personnel, curriculum, financial resources, facilities, clinical resources, field resources, learning resources, and physician interaction. Descriptive statistics of resource deficiency categories were conducted, followed by a thematic analysis of deficiencies to identify commonalities. Themes were generated from evaluating individual deficiencies, paired with program-reported analysis and action plans for each entry. RESULTS: Data from 626 programs were included (response rate = 100%), with 143 programs reporting at least one resource deficiency (23%). A total of 406 deficiencies were identified in the ten categories. The largest categories (n = 406) were medical director (14%), facilities (13%), financial resources (13%), support personnel (11%), and physician interaction (11%). The thematic analysis demonstrated that a lack of medical director engagement in educational activities, inadequate facility resources, and a lack of available financial resources affected the educational environment. Additionally, programs reported poor data collection due to program director turnover. CONCLUSION: Resource deficiencies were frequent for programs graduating paramedic students in 2018. Common themes identified were a need for medical director engagement, facility problems, and financial resources. Considering the pivotal role of EMS physicians in prehospital care, a consistent theme throughout the analysis involved challenges with medical director and physician interactions. Future work is needed to determine best practices for paramedic programs to ensure adequate resource availability for initial paramedic education.

Effects of long-term testosterone treatment on cardiovascular outcomes in men with hypogonadism: Rationale and design of the TRAVERSE study.

BACKGROUND: Testosterone exerts some effects on the cardiovascular system that could be considered beneficial; some other effects may potentially increase the risk of cardiovascular (CV) events. Neither the long-term efficacy nor safety of testosterone treatment has been studied in an adequately-powered randomized trial. METHODS: The Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) study is a randomized, double-blind, placebo-controlled, parallel group, non-inferiority, multicenter study. Eligible participants are men, 45 to 80 years, with serum testosterone concentration <300 ng/dL and hypogonadal symptoms, who have evidence pre-existing CV disease or increased risk of CV disease. Approximately 6,000 subjects will be randomized to either 1.62% transdermal testosterone gel or a matching placebo gel daily for an anticipated duration of up to 5 years. The primary outcome is CV safety defined by the major adverse CV event composite of nonfatal myocardial infarction, nonfatal stroke, or death due to CV causes. The trial will continue until at least 256 adjudicated major adverse CV event endpoints have occurred to assess whether the 95% (2-sided) upper confidence limit for a hazard ratio of 1.5 can be ruled out. Secondary endpoints include prostate safety defined as the incidence of adjudicated high grade prostate cancer and efficacy in domains of sexual function, bone fractures, depression, anemia, and diabetes. RESULTS: As of July 1, 2021, 5,076 subjects had been randomized. CONCLUSIONS: The TRAVERSE study will determine the CV safety and long-term efficacy of testosterone treatment in middle-aged and older men with hypogonadism with or at increased risk of CV disease.

Validity of the Wattbike 3-Minute Aerobic Test: Measurement and Estimation of V̇o2max.

ABSTRACT: Hanson, NJ, Scheadler, CM, Katsavelis, D, and Miller, MG. Validity of the Wattbike 3-minute aerobic test: measurement and estimation of V̇o2max. J Strength Cond Res 36(2): 400-404, 2022-The Wattbike includes a 3-minute aerobic test (3mAT) along with an estimation of V̇o2max. The estimation equation that is used is from a previous study using a different protocol and sedentary subjects. The purpose of this study was to determine whether (a) the 3mAT is able to elicit V̇o2max, and (b) whether this estimation is accurate. Thirteen cyclists (10 men; age: 29.2 ± 10.0 years, height 178.7 ± 8.3 cm, and mass 75.1 ± 12.5 kg) with a range of experience volunteered for this study. At the first visit, a self-paced V̇o2max (SPV) test was performed to obtain the "true" V̇o2max. At the second session, subjects completed the 3mAT. Primary dependent variables included maximal values of oxygen consumption (V̇o2), carbon dioxide production (V̇co2), heart rate (HR), ventilation (VE), and respiratory exchange ratio (RER). A repeated-measures analysis of variance showed no difference (p = 0.367) between V̇o2max values (3mAT estimation: 54.3 ± 9.3 ml·kg-1·min-1, 3mAT measured: 52.5 ± 8.7, SPV: 54.0 ± 9.7). Paired-samples t-tests showed that HR (p = 0.027) was higher in the SPV (184.7 ± 10.6 vs. 180.9 ± 6.3 b·min-1), whereas RER and V̇co2 were both higher in the 3mAT (1.29 ± 0.10 vs. 1.19 ± 0.06 and 4.92 ± 1.01 vs. 4.62 ± 0.98, respectively; both p < 0.05). The intraclass correlation between the V̇o2max measured from the SPV and 3mAT was 0.96 (95% CI: 0.88-0.99, p < 0.001), and between the 3mAT measured and estimated values was 0.91 (95% CI: 0.71-0.97 p < 0.001). If an athlete has access to a Wattbike, they can complete the 3mAT, receive their V̇o2max estimation, and be confident of its accuracy.

The Effects of a Novel Quadrupedal Movement Training Program on Functional Movement, Range of Motion, Muscular Strength, and Endurance.

ABSTRACT: Buxton, JD, Prins, PJ, Miller, MG, Moreno, A, Welton, GL, Atwell, AD, Talampas, TR, and Elsey, GE. The effects of a novel quadrupedal movement training program on functional movement, range of motion, muscular strength, and endurance. J Strength Cond Res 36(8): 2186-2193, 2022-Quadrupedal movement training (QMT) is a form of bodyweight training incorporating animal poses, transitions, and crawling patterns to reportedly improve fitness. This type of training may improve multiple facets of fitness, unfortunately, little evidence exists to support commercial claims and guide practitioners in the best use of QMT. Therefore, the purpose of this study was to assess the impact of a commercially available QMT program on functional movement, dynamic balance, range of motion, and upper body strength and endurance. Forty-two active college-age (19.76 ± 2.10 years) subjects (males = 19, females = 23) were randomly assigned to a QMT ( n = 21) or control (CON) ( n = 21) group for 8 weeks. Quadrupedal movement training consisted of 60-minute classes performed 2×·wk -1 in addition to regular physical activity. Active range of motion, Functional Movement Screen (FMS), Y-Balance Test (YBT), handgrip strength, and push-up endurance were assessed before and after the intervention. The QMT group showed significantly greater improvements than the CON group in FMS composite score (1.62 ± 1.53 vs. 0.33 ± 1.15, p = 0.004) and FMS advanced movements (0.81 ± 0.87 vs. 0.01 ± 0.71, p = 0.002) and fundamental stability (0.57 ± 0.75 vs. 0.05 ± 0.50, p = 0.011), along with hip flexion, hip lateral rotation, and shoulder extension ( p < 0.05). No significant differences between groups were observed for dynamic balance or upper body strength and endurance. Our results indicate that QMT can improve FMS scores and various active joint ranges of motion. Quadrupedal movement training is a viable alternative form of training to improve whole-body stabilization and flexibility.

Recommendations to Increase Neuromuscular Electrical Stimulation Training Intensity During Quadriceps Treatments for Orthopedic Knee Conditions.

ABSTRACT: Neuromuscular electrical stimulation (NMES) is often used by clinicians as a therapeutic adjunct to improve quadriceps strength deficits following orthopedic knee conditions. The efficacy of NMES treatments is primarily dependent on the NMES training intensity, which is a direct result of NMES-induced torque production. The importance of NMES training intensity is well known, yet adequate NMES training intensities are often difficult to achieve due to a variety of limitations associated with NMES (eg, fatigue and patient discomfort). This article provides recommendations that a clinician can use to increase NMES training intensity when strengthening the quadriceps with NMES for orthopedic knee conditions. These recommendations should allow forceful contractions that can be sustained over a treatment with multiple repetitions without the rapid decline in force that is typically seen when NMES is used.

Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial.

BACKGROUND: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. METHODS: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18-85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR) 25-75 mL/min per 1·73 m2 of body surface area, and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g who had received maximum labelled or tolerated renin-angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders) were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days) or end-stage kidney disease (eGFR <15 mL/min per 1·73 m2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure) in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. FINDINGS: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325) or placebo group (n=1323). Median follow-up was 2·2 years (IQR 1·4-2·9). 79 (6·0%) of 1325 patients in the atrasentan group and 105 (7·9%) of 1323 in the placebo group had a primary composite renal endpoint event (hazard ratio [HR] 0·65 [95% CI 0·49-0·88]; p=0·0047). Fluid retention and anaemia adverse events, which have been previously attributed to endothelin receptor antagonists, were more frequent in the atrasentan group than in the placebo group. Hospital admission for heart failure occurred in 47 (3·5%) of 1325 patients in the atrasentan group and 34 (2·6%) of 1323 patients in the placebo group (HR 1·33 [95% CI 0·85-2·07]; p=0·208). 58 (4·4%) patients in the atrasentan group and 52 (3·9%) in the placebo group died (HR 1·09 [95% CI 0·75-1·59]; p=0·65). INTERPRETATION: Atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease who were selected to optimise efficacy and safety. These data support a potential role for selective endothelin receptor antagonists in protecting renal function in patients with type 2 diabetes at high risk of developing end-stage kidney disease. FUNDING: AbbVie.

Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.

BACKGROUND: Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest. OBJECTIVES: Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up. METHODS: In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL ["low T"] vs. ≥300 ng/dL ["normal T"]) on rates of pre-specified CV outcomes, using Cox proportional hazards models. RESULTS: Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively. CONCLUSIONS: In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke. CONDENSED ABSTRACT: In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The "low T" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.

Homeless Shelter Users and Their Experiences as EMS Patients: A Qualitative Study.

Introduction: Patients who are users of homeless shelters interact with EMS and Emergency Departments (ED) as means of accessing the healthcare system. Patients in this population are known to have chronic health conditions as well as being frequent users of EMS. In this study, we researched how patients living at a homeless shelter experienced EMS. Methods: A phenomenological qualitative approach methodology was used to interview individuals at the largest homeless shelter in Omaha, Nebraska in 2017. Data was transcribed then coded for thematic analysis. Results: Eighteen adult individuals participated with four major themes emerging: Frequency and Medical Histories, Perceived Positive Experiences, Perceived Negative Experiences, and Awareness of EMS. Professionalism and being non-judgmental toward a homeless shelter user appeared to best describe the difference between a positive EMS experience from a negative one. Patients of this population have an awareness and appreciation to the role of EMS. They are also aware and recognize overuse of EMS by others and biases from EMS towards patients of this population. There are recognized opportunities to improve the relationship and role of EMS with patients using homeless shelters and services. Conclusion: Support for increased EMS awareness, research, and relationship building with homeless shelter users and shelters is needed.

Advanced Placement Paramedic Education for Health Care Professionals: A Descriptive Evaluation.

INTRODUCTION: The delivery of emergency medical services is primarily performed by emergency medical technicians and paramedics in the United States. More recently, nurses and physicians have become more involved in the delivery of emergency medical services. Advanced placement paramedic education bridging programs have been developed to prepare the workforce, but the success of these programs is unknown. This study evaluated the demographics and performance of nonemergency medical services health care professionals who attended an advanced placement paramedic education program at a Midwestern university. METHODS: This was a retrospective evaluation of student data from 2007 to 2017. Descriptive statistics were used to tabulate demographics, program performance, and individual performance in the National Paramedic Certification Examination. RESULTS: The program admitted 305 students; registered nurses (95%) were the majority of students. Of the 305 admitted students, 271 (88.9%) fulfilled all program requirements and were eligible to take the National Registry of Emergency Medical Technicians paramedic certification examination. Of these 271 eligible students, 201 (74.2%) took the National Paramedic Certification Examination. A total of 195 (97%) obtained certification at the first test attempt, whereas 200 (99.5%) obtained certification within 3 attempts. Of the 200 who passed the test, 175 (88%) successfully demonstrated entry-level competency in paramedic-level psychomotor testing. DISCUSSION: The advanced placement paramedic program evaluated in this study had high rates of successful program completion, as well as high first-time and cumulative passing rates for the National Paramedic Certification Examination. Further research is needed to identify the best practices in determining student requirements and the methodologies in delivering advanced placement paramedic education bridging programs.

Brain activity during self-paced vs. fixed protocols in graded exercise testing.

Electroencephalography research surrounding maximal exercise testing has been limited to male subjects. Additionally, studies have used open-looped protocols, meaning individuals do not know the exercise endpoint. Closed-loop protocols are often shown to result in optimal performance as self-pacing is permitted. The purpose of this study was to compare brain activity during open- and closed-loop maximal exercise protocols, and to determine if any sex differences are present. Twenty-seven subjects (12 males, ages 22.0 ± 2.5 years) participated in this study. A pre-assembled EEG sensor strip was used to collect brain activity from specific electrodes (F3/F4: dorsolateral prefrontal cortex, or dlPFC; and C3/Cz/C4: motor cortex, or MC). Alpha (8-12 Hz) and beta (12-30 Hz) frequency bands were analyzed. Subjects completed two maximal exercise tests on a cycle ergometer, separated by at least 48 h: a traditional, open-loop graded exercise test (GXT) and a closed-loop self-paced VO2max (SPV) test. Mixed model ANOVAs were performed to compare power spectral density (PSD) between test protocols and sexes. A significant interaction of time and sex was shown in the dlPFC for males, during the GXT only (p = 001), where a peak was reached and then a decrease was shown. A continuous increase was shown in the SPV. Sex differences in brain activity during exercise could be associated with inhibitory control, which is a function of the dlPFC. Knowledge of an exercise endpoint could be influential towards cessation of exercise and changes in cortical brain activity.

Cortical neural arousal is differentially affected by type of physical exercise performed.

Critical flicker frequency (CFF) threshold is a visual discrimination task designed to assess cortical neural arousal, where higher values are associated with increased information processing and improved cognitive function. Previous studies using CFF assessments before and after exercise have only used one type of exercise (e.g., short, fatiguing, steady state, time to exhaustion, etc.). Therefore, the purpose of this study was to determine the effect of exercise type and intensity on neural arousal. 22 recreational runners (10 men, 12 women; age 25 ± 6 years) volunteered to participate in the study. They completed a VO2max test (short, fatiguing trial), and three 30-min treadmill runs (longer, steady-state trials) at rating of perceived exertion (RPE) levels of 13, 15, and 17. Before and after each exercise test, subjects were asked to complete the CFF test; Mtot and Mdi were calculated, which are the average and difference of the ascending/descending frequency trials, respectively. There were no main effects found for either intensity (p = 0.641) or time (p = 0.283); there was, however, a significant interaction found (intensity*time; p = 0.001). In the VO2max test and in the longer, steady-state runs at RPE13 and 15, there was no change in Mtot. There was a significant increase in Mtot after the run at RPE17 (p = 0.019). For Mdi, the VO2max test elicited a significant decrease (p = 0.005), but there was no change after the steady-state runs. The results suggest that short, fatiguing and longer, steady-state exercise affect cortical neural arousal differently. Increases in arousal, and perhaps the related domain of information processing, are more likely to come from steady-state exercise at a vigorous intensity.

Deception of Ambient Temperature Does Not Elicit Performance Benefits During a 5 km Run in Hot, Humid Conditions.

Hanson, NJ, Carriveau, DM, Morgan, HE, Smith, AR, Michael, TJ, and Miller, MG. Deception of ambient temperature does not elicit performance benefits during a 5 km run in hot, humid conditions. J Strength Cond Res 32(8): 2250-2257, 2018-The purpose of this study was to investigate the effect of deception of ambient temperature on 5 km performance in recreational runners. Eleven participants (6 men, 5 women) each performed three 5 km runs in a random order consisting of a control trial (CON) in temperate conditions (21° C, 43% RH), a hot humid trial (HOT; 31° C, 65% RH) and a deception trial (DEC; 31° C, 65% RH), where participants were told it was 5° C lower than it actually was. Overall completion time was recorded at the end of trials; thermal sensation (TS), rating of perceived exertion (RPE), and core temperature (TC) were recorded each kilometer. Participants completed the 5 km run faster in the CON condition (23:18 ± 2:05; mean ± SD) compared with DEC (p = 0.005) and HOT (p = 0.014). There was no difference in completion time (p = 0.554) between DEC (25:11 ± 2:41) and HOT (24:25 ± 2:47). Similarly, TS was lower in the CON condition (5.7 ± 0.2) compared with DEC and HOT (p < 0.001 and p = 0.016, respectively) and no differences were seen between the DEC (6.4 ± 0.2) and HOT (6.5 ± 0.2) conditions. No differences in RPE (p = 0.115) or rise in TC (p = 0.289) were seen between the 3 conditions. Deception of the environmental conditions did not positively affect 5 km running performance, and no differences were seen in physiological or psychological variables.

Over-the-counter performance enhancing mouthguards are unable to decrease blood lactate and improve power output during a Wingate anaerobic test (WAnT).

BACKGROUND/OBJECTIVE: Mouthguards are the primary mode of protection against maxillofacial injuries in contact sports, but recent research has also linked performance enhancement to this piece of equipment. The purpose of this study was to test the claims of the Under Armour ArmourBite (UAAB) mouthguard to decrease blood lactate concentration ([BL]) and increase power when compared to a generic over-the-counter mouthguard (OTC) and no mouthguard (NOMG) during an anaerobic performance test. METHODS: Seventeen recreationally active males (23.4 ±â€¯2.7 years; 179.6 ±â€¯7.4 cm; 83.0 ±â€¯14.0 kg) were tested using the 30 s Wingate anaerobic test (WAnT) during three separate testing sessions. RESULTS: There were no differences in [BL] between any of the conditions immediately or 5 min posttest. There were also no differences in peak, relative or average power, or fatigue index during the WAnT. The UAAB mouthguard was therefore unsuccessful in improving anaerobic performance. CONCLUSION: It is likely that more expensive, custom-fit dental mouthguards may be necessary for individuals to see any benefits to athletic performance.

Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF).

BACKGROUND: The Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF) is a patient-reported outcome measurement designed to evaluate the symptoms of hypogonadism. The HIS-Q-SF is an abbreviated version including17 items from the original 28-item HIS-Q. AIM: To conduct item analyses and reduction, evaluate the psychometric properties of the HIS-Q-SF, and provide guidance on score interpretation. METHODS: A 12-week observational longitudinal study of hypogonadal men was conducted as part of the original HIS-Q psychometric evaluation. Participants completed the original HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants completed the Aging Male's Symptoms Scale, the International Index of Erectile Function, the Short Form-12, and the PROMIS Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change scales and a clinical form. MAIN OUTCOME MEASURES: Item performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed. RESULTS: One hundred seventy-seven men participated (mean age = 54.1 years, range = 23-83). Similar to the full HIS-Q, the final abbreviated HIS-Q-SF instrument includes five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For key domains, test-retest reliability was very good, and construct validity was good for all domains. Known-groups validity was demonstrated for all domain scores, subdomain scores, and total score based on the Clinical Global Impression-Severity. All domains and subdomains were responsive to change based on patient-rated anchor questions. CLINICAL IMPLICATIONS: The HIS-Q-SF could be a useful tool in clinical practice, epidemiologic studies, and other academic research settings. STRENGTHS AND LIMITATIONS: Careful consideration was given to the selection of the final HIS-Q-SF items based on quantitative data and clinical expert feedback. Overall, the reduced set of items demonstrated strong psychometric properties. Testosterone levels for the participating men were not as low as anticipated, which could have limited the ability to examine the relations between the HIS-Q-SF and testosterone levels. Further, the analyses used data collected through administration of the full HIS-Q, and future studies should administer the standalone HIS-Q-SF to replicate the psychometric analyses reported in the present study. CONCLUSION: Similar to the original HIS-Q, the HIS-Q-SF has evidence supporting reliability, validity, and responsiveness. The short form includes a smaller set of items that might be more suitable for use in clinical practice or academic research settings. Gelhorn HL, Roberts LJ, Khandelwal N, et al. Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF). J Sex Med 2017;14:1046-1058.

Development of the Hypogonadism Impact of Symptoms Questionnaire Short Form: Qualitative Research.

INTRODUCTION: Hypogonadism in men is often associated with poor libido, erectile dysfunction, irritability, fatigue, and psychological and relationship problems. Many of these symptoms can be best assessed through patient report. The 28-item Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) was developed to evaluate hypogonadism symptoms in men with low testosterone in the context of clinical trials. AIM: To develop a briefer version of the HIS-Q that could be practical for use in treatment settings. METHODS: Participants with low testosterone levels and symptoms consistent with hypogonadism were recruited through clinical sites. Focus groups and interviews were conducted to elicit symptom concepts and identify those that were most relevant to patients, including changes as a consequence of treatment. MAIN OUTCOME MEASURES: Systematic analysis of the qualitative data and expert clinician input were used to develop the HIS-Q short form (HIS-Q-SF). One-on-one cognitive interviews were conducted to confirm the content validity of the HIS-Q-SF. RESULTS: Thirty-five men participated in this qualitative research. Concept elicitation was conducted through focus group discussions (n = 18) and telephone interviews (n = 2); then, the draft HIS-Q-SF was evaluated through cognitive interviews (n = 15). The mean age of total sample was 53.2 ± 6.8 years, and the mean serum total testosterone level was 184.9 ± 55.2 ng/dL. Results suggest that the HIS-Q-SF has demonstrated content validity, including the content coverage, comprehensibility, and the appropriateness of the response options and recall period. The final version of the HIS-Q-SF includes 17 items and is aligned with the original longer version of the instrument. CONCLUSION: The HIS-Q-SF is a comprehensive measurement of hypogonadism symptom severity in men. Content coverage and content validity were confirmed. The instrument will be evaluated further to establish the psychometric characteristics and to assess the utility of the measurement in clinical treatment settings.

Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire.

INTRODUCTION: The Hypogonadism Impact of Symptoms Questionnaire (HIS-Q) is a patient-reported outcome measurement designed to comprehensively evaluate the symptoms of hypogonadism and to detect changes in these symptoms in response to treatment. AIM: To conduct item analysis and reduction, evaluate the psychometric properties of the HIS-Q, and provide guidance on interpreting the instrument score. METHODS: A 12-week observational, longitudinal study of hypogonadal men was conducted. Participants completed the HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants also completed the Aging Male's Symptoms Scale, the International Index of Erectile Function, the Short Form-12 Health Survey, and the Patient-Reported Outcomes Measurement Information System Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (at baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change measurements and a clinical form. MAIN OUTCOME MEASURES: Individual item performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed. RESULTS: In total, 177 men participated in the study (mean age = 54.1 years, range = 23-83). The original 53-item draft HIS-Q was reduced to 28 items; the final instrument included five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For all domains, test-retest reliability was acceptable (intraclass correlation coefficients > 0.70), construct validity was good (|r > 0.30| for all comparisons). Known-groups validity was demonstrated for all HIS-Q domain scores, subdomain scores, and the total score as measured by the Clinical Global Impression of Severity, and total testosterone level at baseline (P < .05 for all comparisons). All domains and subdomains were responsive to change based on patient-rated anchor questions (P < .05 for all comparisons). CONCLUSION: The final 28-item HIS-Q is reliable, valid, and responsive. The HIS-Q is suitable for inclusion in future clinical trials to help characterize the effects of testosterone replacement therapy.

Modality determines VO2max achieved in self-paced exercise tests: validation with the Bruce protocol.

PURPOSE: The Bruce protocol is traditionally used to assess maximal cardiorespiratory fitness (VO2max), but may have limitations, such as an unknown duration and large work rate increases. The use of self-paced VO2max tests (SPVs) may be beneficial if they are able to elicit similar maximal values in a set period of time. In addition, differences in modality between SPVs have not been explored. The purpose of this study was to compare SPVs, utilizing two different modes, with the Bruce (treadmill) protocol. METHOD: Thirteen healthy, recreationally active individuals (eight men, five women) volunteered and participated in three different laboratory visits with each utilizing a different VO2max testing protocol. The first visit consisted of the Bruce protocol test, and the remaining visits entailed a maximal SPV on a treadmill (TM SPV) and a cycle ergometer (CE SPV). RESULTS: There were no differences in VO2max values between the TM SPV and the Bruce protocol tests (55.6 ± 4.9 vs. 56.2 ± 6.8, respectively; p = .510). As expected, the CE SPV (48.3 ± 7.6) was significantly lower than the other two tests (p < .001). CONCLUSION: The TM SPV was as effective in eliciting an accurate VO2max as the Bruce protocol and did so with less incline and in less time suggesting that there are no changes in the limits of VO2max even when the test is self-paced and perceptually regulated.

The Effect of Rocktape on Rating of Perceived Exertion and Cycling Efficiency.

The purpose of this study was to investigate the effects of Rocktape (RT), a type of kinesiology tape, on perceived exertion and cycling efficiency. Eighteen recreational cyclists volunteered as subjects for this study. Four experimental conditions were used: (a) 60% VO2peak with RT, (b) 60% VO2peak without RT, (c) 80% VO2peak with RT, and (d) 80% VO2peak without RT. The Borg rating of perceived exertion (RPE) scale was used to evaluate subjective exertion during the cycling bouts. Overall RPE and leg, arm, and chest RPEs were obtained (RPE-O, RPE-L, RPE-A, and RPE-C, respectively). Gross cycling efficiency was determined by calculating the ratio of the amount of work performed to the energy expended. Repeated-measures analysis of variance was used to investigate the differences between the 2 intensities and 2 tape conditions. There were main effects of intensity (p < 0.001) and tape (p = 0.02) found for the RPE-O, with RPE-C showing similar results for intensity (p < 0.001) and tape (p = 0.02). Similar findings were present for the RPE-C, and main effects of intensity (p < 0.001) and tape (p = 0.02) were discovered. A significant main effect of intensity was found for efficiency (p = 0.03), with the 80% intensity condition showing a greater level of efficiency than the 60% intensity condition. However, the use of RT did not increase gross efficiency (p = 0.61). The main finding in this study was that subjects reported a lower level of exertion overall and at the chest, which may lead to increases in overall performance of these athletes. The use of RT before athletic events should not be discouraged.