Treatment Trials

176 Clinical Trials for Various Conditions

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COMPLETED
The Outcome of Sports Vision Training on Collegiate Softball Players
Description

To investigate the outcomes of sports vision enhancement training on softball players, specifically the visual skills and visual function. This will help to develop and hone best practice methods for future research as well as training protocols for athletes.

RECRUITING
Life After Sport: Prior Injury and Sedentary Behavior as Mechanisms of Later Poor Health
Description

Competitive sport increases risk for musculoskeletal injury (e.g., traumatic knee injury) and may position former athletes for early onset of chronic diseases, chronic pain, poor health-related quality of life, and disability. Quantifying function in former athletes with and without a prior injury and non-athlete controls is critical to understanding long-term health trajectories in athletes and informing potential interventional studies. One modifiable factor that may be associated with long-term health in athletes is physical activity patterns. The purpose of this study is to evaluate strength, function, physical activity, dietary patterns, and cardiometabolic health among current and former competitive athletes and in nonathlete controls to evaluate the impact of prior knee injury and sedentary behavior as two potential determinants of later poor health and reduced function.

ENROLLING_BY_INVITATION
Investigation of Neurocognitive Measures of Sport-Related Injury
Description

The overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. The central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.

UNKNOWN
Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion
Description

Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.

COMPLETED
Neuromuscular Training to Reduce Sports Injuries Among Children and Adolescents
Description

Sports-related injuries are a serious concern for physically active children and adolescents. Previous research, including ours at Chicago public high schools, shows our neuromuscular training program, the Knee Injury Prevention Program (KIPP) reduces sports-related injuries in female athletes by up to 88%. However, KIPP is not well-studied in males or younger age groups. This project aims to determine KIPP's effect on sports-related injuries and physical fitness among 5th-8th grade students in Chicago public schools. The study will take place during the 2011-2013 school years. To measure KIPP's effect on sports injuries, we will recruit 5th-8th grade sports coaches and their athletes, randomize coaches by school into two groups, then train the intervention group to implement a 10-minute KIPP warm-up before practices and games. Control group will perform their usual warm-up. Research assistants will collect athlete participation and injury data from coaches weekly. To determine feasibility of KIPP in PE classes and measure its effect on fitness, we will recruit PE teachers to implement the warm-up in PE classes for a minimum of 10 weeks, and record students' presidential fitness test scores before and after the 10+ weeks. Results of this study will guide strategies for preventing sports-related injuries and improving physical fitness in 5th -8th graders.

Conditions
COMPLETED
PD2i Analysis of Heart Rate Variability in Competitive Sports
Description

This is a double blind observational analysis of changes in heart rate variability using PD2i analyser in competitive athletes during strenuous exercise and competition.

COMPLETED
Safety of Sports for Patients With Implantable Cardioverter-Defibrillators
Description

The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

RECRUITING
Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
Description

This remote study will evaluate the feasibility of using the Gatorade Sports Science Institute (GSSI) Labs App for remotely collecting hydration related outcomes.

Conditions
ENROLLING_BY_INVITATION
Sport-Related Concussion Recovery in Athletes
Description

The goal of this study is to enhance the accuracy and sensitivity of concussion evaluation by integrating traditional assessment tools with emerging neuroimaging technologies, such as Functional Near-Infrared Spectroscopy (fNIRS). By systematically collecting data across multiple assessment domains-including sideline evaluations, neurocognitive testing, balance assessments, vestibular/ocular-motor screening (VOMS), and brain activity measurements-this study aims to improve the diagnostic process and ensure a safer return-to-play protocol for athletes recovering from sport-related concussions. Research Questions: 1. How do traditional concussion assessment tools (SCAT, computerized neurocognitive tests, balance tests, and VOMS) compare to fNIRS in detecting changes in brain function following a sport-related concussion? 2. What is the relationship between pre-injury baseline measures, acute post- injury assessments, and recovery-phase evaluations in athletes diagnosed with a sport-related concussion? 3. Can fNIRS improve the sensitivity and specificity of concussion diagnosis compared to existing clinical assessments? 4. How do clinical symptoms, medical history, and other individual factors influence concussion recovery and return-to-play timelines? 5. Does integrating fNIRS with traditional assessment tools enhance the ability to track recovery progression and inform return-to-play decisions? This study provides a comprehensive evaluation of concussion diagnosis and recovery while assessing the added value of fNIRS technology in improving clinical decision-making.

RECRUITING
Ergonomic Protocol for Competitive E-Sport Athletes
Description

The goal of this clinical trial is to learn if this ergonomic protocol can improve performance and reduce ergonomic risk in esports athletes. It will also learn about the insight of esports athletes and their experience in implementing this new protocol. The main questions it aims to answer are: Does this ergonomic protocol improve performance? Does this ergonomic protocol reduce ergonomic risk? Researchers will assign the protocol to esports athletes who meet inclusion criteria and express interest in participating in the study. A pre-post design will be conducted to note any differences. Participants will: * Participate in a 6-week study with 4 in-person visits * Volunteers will be requested to participate in a focus group during Week 6. * Implement the strengthening protocol 3x a week and a warm up/cool down protocol before and after each gaming session. * Attend one educational session about gaming ergonomics during Week 1 * Complete the Rapid Entire Body Assessment, Kovaaks Asessment, and a Questionnaire during Week Zero, Week 3, and Week 6.

RECRUITING
The Impact of a Caffeinated Sports Drink on Performance
Description

Caffeine is known to enhance physical and mental performance, but few beverages combine caffeine with electrolytes and carbohydrates to enhance exercise performance. This study evaluates a caffeinated electrolyte-glucose drink's effect on endurance, strength, and cognition. Using a repeated-measures, cross-over design, 20 trained cyclists will complete one familiarization and four randomized 3-hour experimental trials (Liquid I.V.™ Energy Multiplier, Hydration Multiplier, Sugar-Free Hydration Multiplier, and water). Each trial includes 2 hours of cycling in a warm environment (32ºC), followed by strength and cognitive assessments. Cycling performance, capillary blood, urine, and expiratory gases will be collected.

RECRUITING
Hoosier Sport: Refining and Implementing a Sustainable Campus-Community Partnership in Rural Indiana
Description

Hoosier Sport is a sport-based youth development program that uses the power of sport to teach children and adolescents sport and leadership skills while promoting health education. Conducted in rural middle and high schools, the program aims to enhance health and wellness by incorporating unique sports such as volleyball and flag football, along with leadership activities like goal setting and health education on the importance of exercise and a healthy lifestyle. The program runs for eight weeks each semester (Fall and Spring), with sessions twice a week during PE class, where college service-learning students lead the curriculum. Data on physical activity and psychosocial factors are collected to assess changes in health, ensuring confidentiality through strict IRB protocols.

COMPLETED
Hoosier Sport Re-Social: A Biobehavioral Intervention in Rural Indiana
Description

Hoosier Sport Re-Social is a sport-based intervention designed to increase physical activity (PA) and reduce social media use among children in under-resourced rural areas, aiming to mitigate cardiovascular disease (CVD) risk. The intervention integrates physical activity with social media literacy (SML) training, addressing the dual challenges of low PA levels and high social media usage, which are prevalent in rural communities.

COMPLETED
Rehydration Efficiency With Different Sports Drinks
Description

It is well established that post-exercise rehydration with a carbohydrate-electrolyte solution is better when compared to plain water. However, most of the commercially available drinks today are high in carbohydrates and sodium with low potassium without other active ingredients. The aim of the present study is to examine the impact of a higher electrolyte sports drink compared with traditional sports drinks and water on the time course and extent of rehydration after exercise-induced dehydration

Conditions
RECRUITING
SportsPro: Post-Market Clinical Follow Up Study
Description

Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)

COMPLETED
Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana
Description

The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities.

ENROLLING_BY_INVITATION
Development and Testing of a Sports Intervention to Promote Physical Activity in Rural Girls
Description

The goal of this study is to examine the impact of a 12-week sports sampling and physical literacy program on rural girls' physical activity.

Conditions
COMPLETED
Mitigating Mental Health Issues Among Women's Sport Student-Athletes Through a Moderate-Intensity Exercise Intervention
Description

The goal of this clinical trial is to learn about moderate-intensity indoor cycling interventions in women's sport student-athletes transitioning into college and collegiate sport. The main question\[s\] it aims to answer are: Aim 1: Establish preliminary feasibility for the intervention based on recruitment and retention rates. Aim 2: Assess efficacy through comparison of pre- and post-intervention mental health outcomes scores between experimental and control groups. Exploratory Aim 3: Explore associations between exercise, athletic, and academic identities and mental health issues post-intervention. Participants will complete an online questionnaire. This online questionnaire will be given before the program begins and after the 4 weeks. The questionnaire will ask about the participants' basic information, the participants' experience with exercise, and the participants' transition experience including mental, physical, and social factors. Participants will be asked to attend an in-person 45-minute exercise class once a week at the University of North Carolina at Chapel Hill (UNC) Student Recreation Center. Participants enrolled in the program will be asked to complete a self-report form during each weekly practice including heart rate (before and after practice) and ratings of perceived exertion. Heart rate will be measured during practice, smart devices (i.e., Apple Watch, FitBit) are not required.

RECRUITING
The Effect of Synaquell™ in Contact Sport Athletes
Description

This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth contact sport athletes.

Conditions
COMPLETED
Virtual Phone Visits Compared to In-Person Physical Visits for Post-Operative Follow-Up at a Sports Medicine Clinic
Description

This study will compare patient reported outcomes (PROs) and patient satisfaction scores of patients seen at virtual phone visits with patients seen at in-person visits for post-operative follow up at 6 weeks, 12 weeks, and 6 months at a sports medicine clinic. This study will determine if there is a difference in PROs and satisfaction scores between these two groups of patients. The investigators hypothesize patients who are seen during a virtual phone visit will report different PRO and patient satisfaction scores compared to patients who are seen during an in-person visit for post-operative follow-up at 6 weeks, 12 weeks, and 6-months.

RECRUITING
Effect of Personalized Pain Coaches After Orthopaedic Surgery for Patients With Sports Medicine Injuries
Description

Patients experiencing sports medicine-related injuries are particularly vulnerable to developing both chronic pain and experiencing prolonged opioid use. This multiarmed randomized controlled trial will quantify the impact of integrating Life Care Specialists, and pain management-focused paraprofessionals, have on increasing access to multimodal pain management approaches and subsequently optimizing both patient-reported pain-related outcomes and objective measures of activity. Life Care Specialists work with patients and clinicians on implementing non-pharmacological pain management approaches, specifically teaching participants how to implement mindfulness-based skills into their recovery, systematically conducting standardized biopsychosocial pain assessments, and coordinating care. By developing a toolbox of pain management approaches with the support of the Life Care Specialist, patients are well positioned to incorporate evidence-based pain management approaches into their recovery that result in improved psychosocial functioning and reduced opioid medication utilization. In total, 150 individuals with sports medicine injuries will be randomized to one of two intervention arms where they will work with a Life Care Specialist in person or over telehealth or receive standard-of-care written postoperative instructions for pain management. Patient-reported outcomes, objective actigraphy movement outcomes captured using wrist-based watches, and opioid utilization captured using medication event monitoring system (MEMS) caps will be evaluated over 3-months postoperatively for a total of 4 study visits.

RECRUITING
MAP for Coaches: Translating Sports Injury Prevention Knowledge to Youth Sport Coaches
Description

The goal of this clinical trial is to test the effectiveness of the MAP for Coaches, a web-based Musculoskeletal Athletic injury Prevention training course, in youth sport coaches. The main question it aims to answer are: * Is the MAP for Coaches effective in increasing coaches' sport-specific knowledge of musculoskeletal injuries (types, incidence, risk factors, mechanisms, and best prevention practices, with focus on neuromuscular training warm-up exercise programs)? * Is the MAP for Coaches effective in increasing coaches' motivation (self-efficacy and intention) to use sport-specific neuromuscular training warm-up exercise programs? The additional questions it aims to answer are: * Are the effects of the MAP for Coaches sustained in the short- and long-term? * Is the MAP for Coaches effective in promoting the use of sport-specific neuromuscular training warm-up exercise programs in youth sport coaches? Regardless of group, participants will receive the MAP for Coaches eLearning training course; however, the participants allocated to the control group will have their post-test survey completed right after they review the sport-specific 2-page injury prevention e-book containing an overview of the MAP for Coaches training course, including an infographic summary (Summarized MAP for Coaches eLearning Training Course). The intervention group will complete the post-test survey after the full training including both the course summary and the detailed course modules (the full training). The investigators will compare the two groups to see if an exposure to the (Full) MAP for Coaches eLearning Training Course improves study outcomes compared with the control group.

COMPLETED
Understanding Sports Nutrition Knowledge of High School Athletes and Influencers
Description

The objective of this testing is to gain a better understanding of sports nutrition knowledge in high school athletes and their influencers (coaches, strength and conditioning coaches, athletic therapists, dieticians). Since the sports nutrition knowledge of the high school athletes will be limited, nutrition behaviors will be assessed to infer knowledge of sports nutrition. The secondary objective is to determine the primary sources of nutrition knowledge in these populations.

UNKNOWN
Andrews Return to Sport ACL Score
Description

This project will develop a data-driven decision making model to assess a competitive athlete's readiness to return to sport after ACL injury and surgery safely.

Conditions
COMPLETED
Impact of Nuun SPORT on Subjective Exercise Performance in Male and Female Runners
Description

The study will examine the impact of the Nuun Sport tablets, as compared to water only, on heart rate, perceived exertion, and related outcomes in male and female runners, during and following the performance of a 60-minute treadmill run.

Conditions
COMPLETED
Pilot Testing an Innovative Physical Activity Intervention for Parents Attending Their Children's Sport Practices
Description

The intervention aims to increase physical activity, an important health behavior, in a high-risk sample (i.e., Black and Hispanic/Latino mothers). The study builds on the investigators' previous work by adapting an evidence-based theory guided physical activity intervention to be implemented in a community setting mothers regularly spend time for their children's extracurricular activities, circumventing barriers commonly cited by racial/ethnic minority mothers (e.g., other responsibilities, time barriers, transportation, and childcare). The investigators will partner with a local youth sports organization to adapt and deliver a physical activity intervention to mothers during practice. They aim to convene a community advisory board of coaches and parents to enhance participant acceptability and work through any feasibility issues with implementation. The investigators will then conduct an open pilot trial of the physical activity intervention administered to mothers during their children's sports practices. They will assess feasibility, acceptability, and examine the effects of the intervention on mothers' physical activity. The investigators hypothesize that mothers in the intervention will increase their physical activity.

COMPLETED
Comparing Sports Bra Design in Full Busted Women
Description

The goal of the current project is to assess performance of the Bounceless Control sports bra versus: (1) the Shefit Ultimate Sports bra, and (2) conventional bra as worn by participants in a variety of athletic activities.

ACTIVE_NOT_RECRUITING
Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study
Description

This study aims to determine the feasibility of implementing a mental skills training intervention for adolescent athletes who tear their ACL and undergo ACL reconstruction surgery alongside receiving standard-of-care clinical treatment. The study will also determine if the mental skills coaching program has any effect on the psychological readiness of patients to return to sport after undergoing surgery and postoperative recovery and rehabilitation. If feasible and if the mental skills training program shows promising effect on athletes' confidence in returning to sport, a large-scale clinical trial can be explored to assess the relationship between mental skills' impact on readiness to return to sport, which could in turn provide evidence on the benefits of integrating mental skills directly into standard clinical care.

Conditions
RECRUITING
Blood Biomarker Study to Diagnose Adolescent Sport Concussion
Description

Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. There is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect. In previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. Based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. The current clinical trial will be conducted in two parts. Part A will allow the investigators to determine precise AUC cut-off values for the propriety, novel custom assay, and in Part B the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.

ACTIVE_NOT_RECRUITING
Neighborhood Park Youth Sports Program Fee Waiver and Intensive Family Outreach
Description

To evaluate a park-level intervention to increase child moderate/vigorous physical activity (MVPA), and decrease sedentary time among low-income racially/ethnically diverse children ages 6-12 yrs. Neighborhood parks (n=20) from Minneapolis (n=8) and Saint Paul (n=12) park systems will be randomized for a 2-year period to one of two arms: 1) Intensive Park Outreach and Youth Sports Program Fee Waiver (n=10); or 2) Youth Sports Program Fee Waiver Only (n=10). The evaluation cohort will consist of 432 children ages 6-12 yrs who reside in one of the 20 randomized park neighborhoods. Measurements from evaluation cohort-enrolled individual children will be collected at baseline, 6, 12, and 24 months.