Treatment Trials

20 Clinical Trials for Various Conditions

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COMPLETED
An Osteopathic Assessment of Lower Extremity Somatic Dysfunction in Runners
Description

Runners often experience acute/chronic pain due to pre-existing structural somatic dysfunction and/or acquired various overuse injuries of the lower extremity, specifically affecting the ligaments, tendons, muscles and bones. Common structural and function dysfunctions include but are not limited to patellofemoral pain syndrome (PFPS), Achilles tendonitis, iliotibial band syndrome (ITBS), ligamentous and muscle tears, muscle sprains/strains, stress fractures, pes planus, plantar fasciitis, and shin splints. The purpose of this study is to assess the correlation between acute and chronic pain, overuse injuries, and observational and palpatory findings upon evaluation. With an understanding of the common trends of somatic dysfunctions and etiology of the pain/injury, modified regimen/routine and improved treatment plans can be developed and recommended for runners to better rehabilitate, minimize relapse and reduce compensatory injuries. No medical or osteopathic treatment will be provided.

COMPLETED
Peak Impact Forces and Metabolic Cost During Mid-Forefoot Striking in Shod Versus Barefoot Runners
Description

This experimental study will compare impact forces and metabolic cost in runners (N=20; ages 18-45 years, who already use a forefoot strike running gait) in two treadmill running test sessions (shod vs barefoot running)

Conditions
RECRUITING
Virtual Physical Therapy Support for Runners
Description

This study will compare standard of care of home exercise for running rehabilitation to the combined treatment of home exercise with an individually provided four-session virtual physical therapy support program intervention on pain and physical function movements (controlled dual and single leg squat and lateral hopping in individuals post running injury. These collective findings will help provide new evidence of the responses to an individually provided virtual PT interventions among runners.

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
Impact Loading Effect on Bone Biomarkers in Female Runners
Description

This study is a randomized, cross-over intervention study that will evaluate the effect of brief, high-impact loading exercises on biomarkers of bone metabolism in energy-restricted, eumenorrheic female runners. Volunteers will complete two, 5-day experimental conditions in a randomized order separated by one menstrual cycle (approximately 3 weeks). Experimental conditions will include a dietary intervention of energy intake equal to 30 kcal/kg of fat-free mass/d using controlled diets and an exercise intervention of daily treadmill running with or without an additional 50 impact loading exercises.

COMPLETED
Four-week Breathing Interventions on Gut Symptoms, Heart Rate Variability, and Psychological Measures in Runners
Description

Recent research has suggested that stress and anxiety levels are associated with gastrointestinal (GI) symptoms in endurance athletes (runners, cyclists, triathletes). Yet, there has been limited attempt to evaluate whether GI symptoms during running can be mitigated by interventions designed to reduce stress and anxiety. Thus, this study will evaluate the effects of four-week slow deep breathing and mindful breath counting interventions on subjective and objective measures of stress/anxiety and GI symptoms in runners with mild-to-high anxiety and that are prone to GI symptoms during runs.

COMPLETED
Strength Training in Female Runners With Patellofemoral Pain
Description

Patellofemoral pain (PFP) is a common running-related injury that is often referred to as runner's knee. The condition typically presents with pain in the front of the knee that is located around or behind the knee cap. This injury occurs twice as frequently in females and is often associated with weakness of the muscles of the thigh and hip, as well as altered running form. Heavy-weight strength training is needed in order to improve muscle weakness; however, this puts a significant amount of load on the knee joint and it is difficult for individuals with PFP to train at this level without experiencing increased pain and joint discomfort. Blood flow restriction training (BFRT) is a promising alternative method to safely improve muscle weakness while reducing knee joint loading. With BFRT, a pressurized band is applied to the thigh in order to partially restrict blood flow as a patient exercises in order to decrease the amount of oxygen delivered to the muscle. Lack of oxygen to the muscle combined with strength training creates an environment within the muscle that results in the ability of low-weight strength training to provide the same results as heavy-weight strength training. This study will evaluate how low-weight strength training with and without BFRT affects thigh and hip strength, and consequently pain, function, running ability, and running form in female runners with PFP. The hypothesis is that 10 weeks of low-weight strength training with BFRT will lead to greater thigh and hip strength, reduced pain, improved knee function, improved running ability, and improved running form compared to low-weight strength training without BFRT. The expected results will have a significant impact within the running community by providing a safe and effective treatment that increases strength and improves running form while reducing pain and joint loading. This will also have an impact on the larger field of sports medicine by providing an alternative method to improve strength, as well as improve function when heavy-weight strength training is not well tolerated or unsafe due to injury.

COMPLETED
Time Restricted Feeding in Male Runners
Description

This is a cross-over intervention study designed to evaluate how four weeks of time restricted feeding (16 hours fasting and 8 hours feeding), compared to four weeks of a more traditional eating pattern (12 hours fasting and 12 hours feeding), affects resting energy expenditure, subjective and biochemical markers of satiety and hunger, body composition, cardiovascular health, substrate utilization and fitness in male competitive runners.

COMPLETED
Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners
Description

The investigators hypothesize that new runners participating in an 8 week strength and coordination training program prior to beginning to run will 1) display different coordination patterns , and 2) experience fewer injuries, compared to new runners who do not perform strength or coordination training prior to running.

COMPLETED
Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
Description

The purpose of this study is to look at the effect of strength training in preventing overuse injuries in female runners

Conditions
COMPLETED
Step Rate in Recreational Runners
Description

This will be a pilot study to determine if a 6 week home training program can increase preferred step rate (cadence) in recreational runners. Increase in step rate has been correlated with decreased stress at lower limb joints in runners. This has the potential of decreasing overuse injuries in this population. Research participants will have their preferred cadence evaluated at the beginning of the study. The athletes will be randomly assigned to two groups. One group will continue to train without intervention and the other group will train at a cadence of 10% higher than their preferred step rate. At the end of 6 weeks the participants will have their preferred cadence reevaluated using the same method as pre-participation cadence was determined. The investigators hypothesis the preferred running cadence of recreational runners following the intervention will be 5-10% greater than prior to the intervention and the increased cadence will be maintained for 6 months following the intervention.

TERMINATED
Running Study for Runners With Chronic Knee Pain
Description

The purpose of this study is to determine whether changing foot strike pattern from a rearfoot strike to a forefoot strike reduces chronic running-related knee pain. It is believed that switching foot strike pattern from a rearfoot strike to a forefoot strike pattern will reduce associated running-related patellofemoral knee pain.

UNKNOWN
The Efficacy of Oral Versus Intravenous Hypertonic Saline Administration in Runners With Exercise-Associated Hyponatremia
Description

The purpose of the study is to 1) evaluate incidence and primary cause of exercise-associated Hyponatremia (EAH) in race finishers participating in the Western States 100-mile Endurance Run, 2) determine if the ingestion of oral hypertonic saline (high salt) is as effective as intravenous administration of hypertonic saline to elevate below-normal blood salt concentrations (EAH) at the end of the Western States Endurance Run, and 3) determine if oral and intravenous hypertonic saline solutions are equally as effective at reversing mild (without altered mental status) symptoms associated with EAH.

COMPLETED
Coronary Artery Disease (CAD) in Women Marathon Runners
Description

The aim of this study is to determine the effects of extreme fitness in women. The incidence of coronary artery disease observed via multislice computed tomography (MSCT) angiogram will be compared with age and risk-matched controls from both sedentary and fitness activity groups who have never been significant runners. Life style, training volume and risk factors will be assessed.

COMPLETED
Bone Geometry, Strength, and Biomechanical Changes in Runners With a History of Stress Fractures
Description

Stress fractures are a common and debilitating injury for a variety of athletes however current evidence does not clearly allow easy prediction of athletes at risk for a first fracture. Animal and some preliminary human evidence suggest that assessment of bone strength, muscle size and running mechanics may be primary risk factors for stress fractures. The investigators study will help determine which, if any, of these modifiable risk factors could help identify athletes at risk for stress fracture. Competitive female distance runners will be recruited for this study. Participants will placed into a stress fracture or control group based on stress fracture history. Dual energy x-ray absorptiometry (DXA) and peripheral Quantitative Computed Tomography (pQCT) will be used to assess bone structure and strength. Running mechanics will be assessed during a 30-40 minute fatiguing run. A treadmill with an embedded force plate and high speed video will be used to assess changes in running mechanics throughout the run. The purpose of this project will be to 1. explore differences in volumetric bone mineral density (vBMD), bone geometry, and muscle cross sectional area (MCSA) using pQCT 2. explore changes in load (GRFs) and running mechanics that occur during a fatiguing run in runners with and without a history of stress fracture.

COMPLETED
Impact of Osteopathic Manipulative Therapy on Hip Range of Motion
Description

One way for runners to improve their performance and remain injury free is to preserve and improve joint mobility, especially at the hips. The femoroacetabular joints are a pivotal part of the running gait allowing the athlete to fully extend their leg to generate sufficient force in each stride. Improving hip range of motion can help reduce or prevent groin pain, make the runner more comfortable while running, improve running longevity, and prevent injuries. Thus, it is clear that a runner's commitment to improving the range of motion of their hips is crucial for both the enhancement of their performance and prevention of injury. Researchers assessed how the hip, and its biomechanics, can be impacted by Osteopathic medical treatment. The primary research question investigated is how Spencer Technique for the hip impacts femoral acetabular active range of motion (AROM) in flexion, extension, abduction, adduction, internal rotation, and external rotation in those training 4 weeks for a 5K race. This study investigated the effect that 4 weeks of twice weekly, bilateral, Spencer Technique treatment had on femoroacetabular range of motion. During this 4-week period participant exercise and stretching habits in preparation for the 5k race were recorded.

Conditions
ACTIVE_NOT_RECRUITING
Examining the Most Effective Method to Reduce Running Ground Contact Time
Description

The purpose of our study is to establish the most effective running retraining technique to decrease ground contact time. This will be investigated by applying three running retraining conditions and assessing the change in ground contact time and other biomechanical variables between the runner's baseline running and each retraining technique.

Conditions
RECRUITING
Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A
Description

Chronic Exertional Compartment Syndrome (CECS) is a painful condition affecting runners and it is caused by a reversible increase in pressure within a closed compartment in the leg. Currently, to diagnose CECS, a large needle is placed into the muscle to measure pressure, which is invasive and painful. After diagnosis, the gold standard of treatment is surgery, which is also invasive, involves a prolonged return to play, and has a significant number of treatment failures. A growing literature has suggested alternative methods to both diagnosis and treatment that include the use of ultrasound to investigate muscle stiffness with shear wave elastography (SWE), and treatment with botulinum toxin injection into the muscle. The investigators propose a single-site randomized clinical trial to investigate the use of abobotulinumtoxinA in the treatment of CECS. Researchers also look to develop a non-invasive method for the diagnosis of CECS using SWE. To the researchers' knowledge, this is the first randomized study investigating the medication to treat this cause. The study will take place at Emory's outpatient sports medicine clinic. Potential participants will primarily be identified and recruited from the departments of Physical Medicine and Rehabilitation, Orthopedics, Physical Therapy, and Sports medicine as a part of regular clinical care. Participants will be included in the randomized portion of the study if they meet the previously established diagnostic criteria for CECS with compartmental pressure testing. This would be a landmark study to provide evidence for the use of an abobotulinumtoxinA in the treatment of CECS, leading to the potential avoidance of a surgical procedure. It could also change the means of diagnosis without the use of painful and invasive needle pressure testing that would provide patients and athletes with ease of care.

COMPLETED
Ultrarunners Longitudinal TRAcking Study (ULTRA)
Description

Health status information and physical activity level will be collected longitudinally on a large group of individuals who are ultramarathon runners at the time of enrollment to determine if very high levels of physical activity alter health risks compared with sedentary or moderately active lifestyles.

COMPLETED
Conventional Home Exercise Programs Versus Electronic Home Exercise Versus Artificial Intelligence "Virtual Therapy" for Anterior Knee Pain
Description

This is a clinical research trial to evaluate the efficacy of delivering exercise therapy for knee pain via the Internet utilizing an algorithm designed to adjust a home exercise program based on user input. The investigators hypothesize that exercise therapy can be delivered safely and effectively with increased participant satisfaction compared to the current standard.