Clinical Research Directory

Bone Stimulator for Spondylolysis

This prospective study aims to investigate the effectiveness of bone stimulator therapy as adjunct treatment of spondylolysis in athletic populations. By evaluating its impact on pain reduction, functional improvement, osseous bony union and return-to-sport time, the investigators seek to provide valuable insights into the role of bone stimulation therapy as a potential treatment modality for this challenging condition.

Validity of Thermal Imaging in Injury Risk Assessment in Volleyball Players

Although studies in the literature have used thermography for injury prevention and performance monitoring in various sports, no systematic validation of the method has been conducted in volleyball players. This study aims to determine whether thermography is a reliable and standardized tool for injury risk assessment.

Acute Effects of Different Warm-Up Protocols in Competitive Young Swimmers

Several warm-up strategies are commonly employed by athletes to optimize athletic performance and minimize the risk of injury. Recently, Post-Activation Performance Enhancement (PAPE) has been demonstrated to be effective in improving athletic performance. Nevertheless, the difference with the general warm-up is still unclear and poorly studied. Conventionally, short-term performance improvements achieved after brief periods of maximal activity have been attributed to PAP, a muscle memory mechanism that generates involuntary and short-lived effects (\~28 seconds). This condition appears to be activated only by a history of localized maximal contractions. In the literature, various conditioning protocols with differing durations and intensities have been explored, often finding conflicting results in terms of athletic performance. In swimming, few PAPE warm-up protocols outside the pool have been studied, despite their potential usefulness considering the waiting times before competitions. Therefore, this study explores the effects of three different warm-up protocols in young swimmers. Specifically, different exercise protocols will be included in the athletes' usual warm-up routine, aimed at improving athletic performance through PAPE effects. In line with existing literature, the performance parameters examined are the countermovement jump (CMJ) and the times recorded for covering race distances ( 25 m, 50 m, 100 m). In addition, skin temperature, heart rate (HR), muscle oxygen saturation (SmO2), and perceived exertion (RPE) are also measured after the protocols to investigate possible relationships with performance measures. Nevertheless, the primary aim of this study is to compare different warm-up protocols in young swimmers to maximize their athletic performance.

The Effects of Scapular Stabilization Exercises in Traditional Archery Athletes

This randomized controlled trial aims to investigate the effects of an 8-week scapular stabilization exercise program on shooting accuracy and upper extremity performance in athletes engaged in traditional archery. Thirty licensed archers aged between 15 and 35, with at least 2 years of experience, will be randomly assigned to an intervention group or a control group. The intervention group will receive scapular stabilization exercises in addition to their regular training, while the control group will continue their usual training routine. Pre- and post-intervention evaluations will assess upper extremity strength, stability, proprioception, and shooting performance.

The Swedish Hockey League Hand and Wrist Injury Tracking Trial

This study, titled Hand and Wrist Injuries in Professional Hockey Players in Sweden: A Nationwide Observational Cohort Study from the Swedish Hockey League (SHL-HITT), aims to deliver a comprehensive national overview of hand and wrist injuries among professional hockey players. These injuries are relatively common-accounting for approximately 16% of all hockey-related injuries-and can range from minor issues to severe conditions that jeopardize player performance and careers due to prolonged absences or lasting impairment. Despite their significance, there is limited detailed knowledge regarding the specific patterns, mechanisms, and consequences of hand and wrist injuries at the elite level. Utilizing data from a nationwide injury registry, this observational cohort study will cover three full SHL seasons: 2022/23, 2023/24, and 2024/25. The dataset is expected to include approximately 2,300 games, encompassing both regular season and playoff matches. The study will examine injury characteristics such as type (e.g., fractures, soft tissue damage), player position, in-game timing, and additional contextual factors. Statistical analyses will be conducted to identify trends, correlations, and potential risk profiles among different player groups or positions. The findings are expected to support the development of enhanced protective equipment and targeted prevention strategies, ultimately contributing to reduced injury incidence and improved athlete health and career sustainability. The study timeline includes preparation in late 2024, with data collection already ongoing and ethical approval obtained. The analysis will begin following the publication of the study protocol, and we aim for final publication of results in the second half of 2025.

Effects of CreaSafe® on Kidney, Muscle, and Cardiopulmonary Function in Athletes and COPD Patients

Creatine supplementation (CS) offers numerous health benefits, with no proven side effects reported to date. CS positively impacts all organs and systems of the body. However, there is an ongoing effort among several creatine-producing companies to develop increasingly pure creatine formulations that generate fewer renal metabolites. Therefore, this study aims to evaluate the effects of a new creatine formulation, CreaSafe®, synthesized by the Chinese company Wenda®, on kidney function in athletes and patients with chronic obstructive pulmonary disease (COPD), as well as its effects on skeletal muscles and cardiopulmonary function. Regarding the athletes (Study 1), the sample will consist of 80 healthy athletes (40 strength-training athletes and 40 middle- and long-distance runners). Among each group of 40 athletes, 20 will receive CreaSafe® creatine (0.03 g/kg/day), while the other 20 will receive a placebo (microcrystalline cellulose; 0.03 g/kg/day), for 90 days, orally administered in water in the morning (between 7:00 a.m. and 9:00 a.m.). For the COPD patients (Study 2), 60 patients with severe and/or very severe COPD will be recruited. Of these, 30 will receive CreaSafe® creatine (0.03 g/kg/day), while the other 30 will receive placebo (microcrystalline cellulose; 0.03 g/kg/day), also administered orally in water for 90 days in the morning (between 7:00 a.m. and 9:00 a.m.). The supplementation period for both studies will last 90 days, with assessments performed at baseline and after 90 days. Kidney function will be evaluated through urinalysis (Urine Type I), the balance of pro- vs. anti-inflammatory cytokines, and levels of urea, creatine kinase (CK), and creatinine. Body composition will be assessed using octopolar and multifrequency bioimpedance, along with circumference measurements of body segments. Muscle strength of different muscle groups will be assessed using the E-lastic dynamometer. Biomarkers of skeletal muscle degradation and recovery will also be measured in plasma, including CK, lactate dehydrogenase (LDH), urea, myoglobin, and the levels of IL-1beta, IL-4, IL-6, IL-10, TNF-alpha, Atrogin-1, MuRF-1, and GDF-8 (myostatin). Whole blood analysis (erythrocytes, leukocytes, and platelets) will be performed using a fully automated blood analyzer (Sysmex XS 800i). Pulmonary function will be assessed through pre- and post-bronchodilator spirometry, as well as maximal inspiratory (PIMax) and expiratory (PEMax) pressures using a manovacuometer. Cardiovascular function will be evaluated using electrocardiography (ECG) and cardiovascular hemodynamics assessed by impedance cardiography (PhysioFlow). GraphPad Prism 5.0 software will be used for statistical analyses and graph generation. Paired Student's t-tests will be used to compare pre- and post-intervention values within each group, and unpaired Student's t-tests will be used to compare deltas between the CreaSafe® and placebo groups. Statistical significance will be considered at p ≤ 0.05.

Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia

This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.

Oslo Footballplayers Iron Supplementation and Training (FIT) Study

The aim of the study is to characterize the diet and iron status of young female elite football players and examine the relationship between iron intake, iron status, hemoglobin levels, intestinal health and sports performance. In addition, the effects of low-dose iron supplements on iron stores will be investigated and whether such supplementation affects intestinal health, microbiota composition and biomarkers for oxidative stress.

Relationship of Anthropometric Profile and Fitness Indicators With Sports Performance of Elite Mexican National Team Soccer Players

Relating Anthropometric Profile to Fitness and Sports Performance in Mexican National Team Soccer Players

Impact of Delivery Method Elite Athletes.

Labor itself can occur spontaneously vaginally, with the help of extraction methods, or via cesarean section. It can also be planned or awaited for the spontaneous onset of uterine contractions. Each method has its advantages and disadvantages regarding potential damage to the pelvic floor and its stability in vaginal delivery or extraction methods, or concerning the stability of the abdominal wall with subsequent wound healing after a cesarean section. The aim of the study is to retrospectively and prospectively determine the impact of the method of delivery on the performance of female athletes through a questionnaire study. Investigators would like to answer the question of whether cesarean delivery means a later return to training for athletes, whether pregnancy is problematic for female athletes in relation to their BMI, and whether pregnancy often signifies the end of a sports career for female athletes. The questionnaire also includes questions regarding overall women's health-menstrual cycle, incontinence, and mental health of female athletes. Prospectively, the questionnaire will be sent to all female athletes who meet representation limits once a year and for two years after retiring from the national team.

Effects of Myofascial Release Technique on Mobility, Sensorimotor Function and Performance in Volleyball Players

Sports that require overhead activities (volleyball, tennis, basketball) include components such as rapid displacement, strength and movement control.Volleyball is also called as an overhead sport in terms of the way it is played. In the realization of these sports; Sub-parameters such as proprioceptive sense, strength, throwing rate, flexibility play a role. During these activities, the shoulder and elbow joints are overloaded. To meet this load, the joint must provide the necessary mobility and stability. Proprioceptive sense in increasing the quality and width of movement as well as providing dynamic joint stability in overhead sports; Increasing the range of motion of the joint, reducing muscle stiffness and thus increasing flexibility are effective in providing mobility. That's why it's important to develop them. Likewise, muscle strength should be increased in order to maintain movement performance and prevent injuries. The use of myofascial release techniques as an exercise method has increased in recent years. Application; The effects on parameters such as strength, performance and flexibility were investigated. Studies have focused more on the lower extremities and acute effects. There is no study on the subject examining proprioceptive sensation in volleyball players in the upper extremity. Therefore, our aim is to examine the chronic effects of the application on shoulder and elbow joint mobility, sensorimotor function and performance.

Quantum Menstrual Health Monitoring Study

The Quantum Menstrual Health Monitoring Study will measure four key reproductive hormones in the urine to characterize patterns that predict and confirm ovulation, referenced to serum hormones and the gold-standard of the ultrasound day of ovulation in participants with regular cycles. These normal cycles will provide a reference for comparison to irregular cycles in polycystic ovarian syndrome (PCOS) and athletes. Clinical signs in the menstrual cycle (e.g. menstrual bleeding, temperature) as well as vital sign and sleep patterns will also be referenced to hormonal changes.

Acute Effects of Foam Rolling and Proprioceptive Neuromuscular Facilitation Stretching

The hamstring muscle is one of the key elements in rehabilitation programs and sports activities that enable the restoration of optimal muscle length. Decreased flexibility in the hamstring muscle may disrupt the biomechanics of the waist and pelvis, leading to low back pain or musculoskeletal disorders. This study aims to investigate the acute effects of foam rolling and proprioceptive neuromuscular facilitation stretching during warm-up on muscle flexibility, strength, and pain threshold in amateur athletes. According to our research, there is no study in this field in the literature. H1: There is a difference between the acute effects of foam rolling exercise and PNF stretching exercise on muscle flexibility during warm-up in amateur athletes. H2: There is a difference between the effects of foam rolling and PNF stretching exercises used as warm-up exercises on muscle strength. H3: Foam rolling and PNF stretching exercises applied to the Hamstring muscle as a warm-up exercise make a difference in the pain threshold of the lumbar region and Hamstring muscle.

Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes

Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking. The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes. 200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC. Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment.