Influence of Dietary Nitrate Supplementation on Physical Performance and Body Composition Following Offseason Training in Division I Athletes.

Purpose: To determine the effects of dietary nitrate supplementation, in the form of red spinach extract (RSE), on adaptations to offseason training in collegiate athletes.Methods: Sixteen Division I male baseball athletes (20.5 ± 1.7y, 90.4 ± 0.5 kg) enrolled in this study and were randomized into a RSE (n = 8) or placebo (n = 8; PL) group. Athletes completed an 11-week resistance training program during the offseason, which consisted of 2-3 workouts per week of upper and lower-body exercises and baseball-specific training. Athletes consumed a RSE (2 g; 180 mg nitrate) or PL supplement daily for the entire offseason training program. Pre and post-training, all athletes underwent one-repetition maximum (1RM) strength testing for the bench press and completed a Wingate anaerobic cycle test (WAnT). Body composition analysis was completed via a 4-compartment model, as well as muscle thickness (MT) measurement of the rectus femoris (RF) and vastus lateralis (VL) via ultrasonography. Resting heart rate and blood pressure (BP) were also obtained. Separate repeated measures analyses of variance were used to analyze all data.Results: Significant (p ≤ 0.05) main effects for time were observed for improved bench 1RM, fat-free mass, body fat percentage, RF MT, and VL MT. No significant group x time interactions (p > 0.05) were found for any measure of performance, body composition, or cardiovascular health. However, a trend for improved peak power in the WAnT was observed (p = 0.095; η2=0.200).Conclusions: These data suggest that daily RSE supplementation had no effect on performance, body composition, or cardiovascular measures in male Division I baseball players following offseason training.

A diagnostic confidence scheme for CLN3 disease.

Over the past 20 years, diagnostic testing for genetic diseases has evolved, leading to variable diagnostic certainty for individuals included in long-term natural history studies. Using genotype and phenotype data from an ongoing natural history study of CLN3 disease, we developed a hierarchical diagnostic confidence scheme with three major classes: Definite, Probable, or Possible CLN3 disease. An additional level, CLN3 Disease PLUS, includes individuals with CLN3 disease plus an additional disorder with a separate etiology that substantially affects the phenotype. Within the Definite and Probable CLN3 disease classes, we further divided individuals into subclasses based on phenotype. After assigning participants to classes, we performed a blinded reclassification to assess the reliability of this scheme. A total of 134 individuals with suspected CLN3 disease were classified: 100 as Definite, 21 as Probable, and 7 as Possible. Six individuals were classified as CLN3-PLUS. Phenotypes included the classical juvenile-onset syndromic phenotype, a "vision loss only" phenotype, and an atypical syndromic phenotype. Some individuals were too young to fully classify phenotype. Test-retest reliability showed 96% agreement. We created a reliable diagnostic confidence scheme for CLN3 disease that has excellent face validity. This scheme has implications for clinical research in CLN3 and other rare genetic neurodegenerative disorders.

Feasibility, Reliability, and Value of Remote Video-Based Trial Visits in Parkinson's Disease.

BACKGROUND: There is rising interest in remote clinical trial assessments, particularly in the setting of the COVID-19 pandemic. OBJECTIVE: To demonstrate the feasibility, reliability, and value of remote visits in a phase III clinical trial of individuals with Parkinson's disease. METHODS: We invited individuals with Parkinson's disease enrolled in a phase III clinical trial (STEADY-PD III) to enroll in a sub-study of remote video-based visits. Participants completed three remote visits over one year within four weeks of an in-person visit and completed assessments performed during the remote visit. We evaluated the ability to complete scheduled assessments remotely; agreement between remote and in-person outcome measures; and opinions of remote visits. RESULTS: We enrolled 40 participants (mean (SD) age 64.3 (10.4), 29% women), and 38 (95%) completed all remote visits. There was excellent correlation (ICC 0.81-0.87) between remote and in-person patient-reported outcomes, and moderate correlation (ICC 0.43-0.51) between remote and in-person motor assessments. On average, remote visits took around one quarter of the time of in-person visits (54 vs 190 minutes). Nearly all participants liked remote visits, and three-quarters said they would be more likely to participate in future trials if some visits could be conducted remotely. CONCLUSION: Remote visits are feasible and reliable in a phase III clinical trial of individuals with early, untreated Parkinson's disease. These visits are shorter, reduce participant burden, and enable safe conduct of research visits, which is especially important in the COVID-19 pandemic.

Video research visits for atypical parkinsonian syndromes among Fox Trial Finder participants.

BACKGROUND: Use of video research visits in neurologic conditions is rising, but their utility has not been assessed in atypical parkinsonian syndromes. We sought to evaluate the diagnostic concordance between video-based vs self-reported diagnoses of multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and corticobasal syndrome. We also assessed patient satisfaction with video-based visits. METHODS: We conducted a study of video-based research visits in individuals with an atypical parkinsonian syndrome enrolled in The Michael J. Fox Foundation's Fox Trial Finder. Participants completed a recorded real-time video visit with a remote evaluator who was blinded to the participant's self-reported diagnosis. The investigator conducted a structured interview and performed standard assessments of motor function. Following the visit, the investigator selected the most likely diagnosis. The recorded visit was reviewed by a second blinded investigator who also selected the most likely diagnosis. We evaluated diagnostic concordance between the 2 independent investigators and assessed concordance between investigator consensus diagnosis and self-reported diagnosis using Cohen's kappa. We assessed participant satisfaction with a survey. RESULTS: We enrolled 45 individuals with atypical parkinsonian syndromes, and 44 completed the investigator-performed video assessment. We demonstrated excellent concordance in diagnosis between the investigators (κ = 0.83) and good reliability of self-reported diagnosis (κ = 0.73). More than 90% of participants were satisfied or very satisfied with the convenience, comfort, and overall visit. CONCLUSIONS: Video research visits are feasible and reliable in those with an atypical parkinsonian syndrome. These visits represent a promising option for reducing burden and extending the reach of clinical research to individuals with these rare and disabling conditions.

Symptom burden among individuals with Parkinson disease: A national survey.

OBJECTIVE: To explore disease burden in Parkinson disease (PD) by evaluating the prevalence of symptoms and key disease milestones (critical events, e.g., hospitalization or frequent falls) and their association with quality of life (QOL) in those with PD. METHODS: We created and pretested an online needs assessment survey to evaluate the clinical characteristics, QOL, symptom prevalence, and critical event frequency among those with PD. We recruited individuals with self-reported Hoehn and Yahr stage II-V PD through online postings and email through the Davis Phinney Foundation. We used logistic regression to evaluate the association between a large number of uncontrolled symptoms and events on QOL. RESULTS: A total of 612 individuals (mean age 70.1 years, 49.8% women) completed the survey. Among respondents, 13.6% reported poor QOL. Nearly 20% of respondents reported >3 falls, and 15% of respondents had been hospitalized over the previous 6 months. Participants had an average of 5.1 uncontrolled symptoms, with 86.1% of respondents reporting at least 1 uncontrolled symptom; more than 10% of respondents reported >10 uncontrolled symptoms. Depression, confusion, pain, and bothersome hallucinations were associated with poor QOL among the cohort. CONCLUSIONS: In this national survey of individuals with PD, we identified poor QOL, frequent critical events, and numerous uncontrolled symptoms among a substantial proportion of respondents. Although motor symptoms were common, only nonmotor symptoms were associated with poor QOL. Many of these symptoms and events are treatable or preventable, highlighting the need for better identification and management to improve QOL among those with PD.