45 Clinical Trials for Various Conditions
Aging is associated with a decline in muscle mass, strength, and physical function, leading to sarcopenia and frailty. This deterioration of muscle and physical capabilities impacts an individual's functional independence and quality of life. Dietary protein stimulates muscle protein synthesis. Therefore, nutritional interventions that recommend higher protein intakes may enhance muscle protein synthesis. Food intake, including protein-rich foods such as red meat, has been shown to decline with age. Barriers to consuming protein-rich foods include reductions in taste and smell, dentition and dexterity, and changes in living situations. Therefore, nutritional interventions that can effectively improve eating behaviors and diet quality while stimulating muscle protein synthesis in older adults are necessary to help prevent, manage, and promote recovery of sarcopenia. To reduce potential barriers of red meat consumption in community-dwelling older adults, an additional beneficial strategy may be the use of cooking demonstrations, or culinary medicine, by imparting knowledge about healthy cooking to improve the dietary habits of individuals who are at risk of sarcopenia. In this approach, people will be educated about age-appropriate, healthy eating behaviors and equipped with basic cooking skills to incorporate nutritious food into their daily diet. A systematic review concluded that culinary interventions such as cooking classes effectively improved attitudes, self-efficacy, and healthy eating in children and adults. A recent study using cooking videos to encourage the consumption of calcium-rich foods showed that the subjects gained knowledge and were motivated to consume calcium-rich foods, and video demonstrations were accepted as an effective communication channel to impart cooking skills. Additionally, it is suggested that cooking at home improves adherence to healthy nutrition, thereby reducing chronic illness risks. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Thus, cooking demonstrations can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. Culinary medicine is an evidence-based field that combines skills of preparing, cooking, and presenting food with the science of medicine to accomplish potential improvements in eating behaviors and health outcomes. The goal of culinary medicine is to help people improve their diet quality which assists them in their medical regimen to produce an effective treatment.
Aging is associated with a decline in muscle mass, strength, and physical function, leading to muscle mass loss and weakness. These concerns can impact an individual's functional independence and quality of life (QOL). Dietary protein stimulates muscle protein growth. Current studies suggest that optimal protein intake for older adults is greater than the Recommended Dietary Allowance. Barriers to consuming protein-rich foods in older adults include reductions in taste and smell, dentition, dexterity, and changes in living situation. Therefore, nutritional interventions are needed to effectively improve eating behaviors, diet quality, and stimulate muscle growth and strength. These interventions will help prevent, manage, and promote muscle mass loss recovery. Older adults may not be aware of their changing nutrient needs and therefore may lack the skills to prepare nutritionally adequate foods properly. Cooking demonstrations, or culinary medicine (CM), can help teach healthy cooking to reduce potential red meat consumption barriers and improve community-dwelling older adults' dietary habits. Thus, CM can be a novel strategy to improve diet quality in older adults and promote and augment at-home cooking. CM is an evidenced-base field that combines skills of preparing, cooking, and presenting food with the science of medicine. This field can help to accomplish potential eating behaviors and health outcome improvements. A tailored CM program can be an effective strategy that could reduce barriers in protein intake that will enable older adults to age well and productively.
This study will evaluate the adaptations in skeletal muscle that occur in response to 10 weeks of weight training with or without peanut protein supplementation in untrained men and women ages 18-30
This study will evaluate the adaptations in skeletal muscle that occur in response to 10 weeks of weight training with or without peanut protein supplementation in older adult men and women.
Currently there is no standard way to detect age-related skeletal muscle loss in patients with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways to measure muscle size and fat within the muscle.
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from dairy and other animal source proteins) with calorie restriction and low-intensity exercise on muscle quality and muscle adipose infiltration (along with bone mineral density \[BMD\] and a number of secondary outcomes) in frail, obese, older adults participating in a 6 month intervention. The investigators will compare these effects to those of a traditional control regimen of calorie restriction and low-intensity exercise over the same duration.
A physical training program will improve quality of life, participation in physical activity, motor coordination, muscle strength, and bone and muscle strength in children with neurofibromatosis type 1.
Frailty is an age-associated clinical condition of poor physiological reserve that increases risks for falls, hospitalization and mortality. Nicotinamide adenine dinucleotide (NAD) is a critical co-factor needed for many cellular processes. The natural levels of NAD decline aging and this has been linked to physical performance decline in animals. Human trials have demonstrated that nicotinamide riboside (NR), a form of vitamin B3, is safe and effectively increases NAD+ levels. In animal studies, NR improves treadmill performance and muscle quality. Here the investigators propose a double-blind randomized control trial to assess the benefits of NR supplementation on human muscle function and physiology. The investigators anticipate the research findings will support the use of this nutritional supplement to improve the health of Veterans during aging.
The purpose of this study will be to evaluate whether dumbbell resistance training (DBRT) or elastic band resistance training (EBRT) is beneficial in older adults whom may be classified as sarcopenic based on the collective operational definition and older adults that do not meet the criteria to be considered sarcopenic compared to non-exercise controls of these populations after sarcopenia criteria have been established. As well as identify if resistance exercise will improve muscle quality in older adults, considering how muscle quality relates to sarcopenia status. Specific Aim 1 will determine if short-term resistance training will alter muscle quality or sarcopenia status in older adults compared to non-exercise controls. The study team will instruct and supervise adults aged 55-85 in structured, periodized EBRT or DBRT for 6 weeks. After the training, muscle quality and sarcopenia status will be re-evaluated. It is hypothesized that both types of training (EBRT and DBRT) will improve the sarcopenia status of older adults engaging in resistance training and if sarcopenic, their classification may change to non-sarcopenic. A secondary hypothesis is that EBRT will be more beneficial than DBRT, resulting in greater changes in body composition, strength, and functional movements. It is also hypothesized that muscle quality, as an index of relative strength, will improve after 6 weeks of resistance training with either dumbbells or elastic bands and that there is a strong negative linear relationship between severity of sarcopenia and muscle quality. Specific Aim 2 will evaluate the prevalence of sarcopenia in older adults using previously-identified equations and cut-off values and to subsequently generate a new index to include functional muscle mass and performance to identify sarcopenic individuals. This will be completed using muscle mass estimations from dual-energy x-ray absorptiometry (DEXA), bioelectrical impedance analysis (BIA), functional performance measures, and structural composition. It is hypothesized that DEXA and BIA will provide accurate estimates of appendicular lean mass (ALM), and functional performance (handgrip strength and gait speed) will be significant contributors to a predictive equation of a muscle quality index for men and women.
The popularity of marathons and endurance events has increased over the last few decades and, interestingly, the demographics of participants have also changed. From 1980 to 2002 the average race time to complete the marathon lengthened from \~3.5 hours to \~4.5 hours. Likewise, many endurance races include "Clydesdale" and "Athena" divisions for heavier weight male and female runners, respectively. As such, there has been an increase of overweight and obese participants in these races. For example, one study consisting of 250 runners determined, according to BMI, that approximately 15% and 31% of the female and male participants, respectively, were classified as overweight, with 31% and 33% classified as obese. Therefore, many recreational endurance athletes are overweight despite their high level of activity. On one hand, these data are positive as regular exercise reduces cardiovascular disease and all-cause mortality in overweight and obese populations. Yet, it is well documented in sedentary obese individuals that excess adiposity can lead to disturbances in adipocyte lipolysis and altered substrate utilization at rest and during exercise, and can decrease muscle quality. However, it is unknown if overweight individuals that exercise regularly have disrupted fat metabolism, circulating hormones, or muscle quality. No study has directly determined if differences exist in fat metabolism, circulating hormones, and muscle quality between overweight recreational female athletes and their lean counterparts when training status is equivalent. Therefore, the purpose of this investigation is to determine if differences in pre and post-exercise fat metabolism, circulating insulin and growth hormone, and muscle quality exist between active overweight individuals compared to active lean individuals with similar training history and who have regularly trained for and participated in endurance events within the last few years.
The study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size.
The prevalence of obesity continues to increase at an alarming rate for all sectors of the population in the US. Obesity in the older adult cohort is of great concern as it is associated with reductions in mobility, declines in physical performance and increased risk for physical disability. With regard to body composition, a) fat mass has been determined to be a stronger predictor of mobility limitations than low muscle mass in older individuals and alternatively, b) leg lean mass has also been cited as a primary determinant of lower extremity physical function. Obesity is related to increased levels of fatigue and lack of motivation and mental energy. Fatigue can be categorized as both a subjective perception and a performance decrement. Fatigue can be defined as a perceived lack of physical or mental energy while fatigability is another construct categorized by the degree of fatigue associated with activity in any dimension (i.e. physical, mental, emotional, and/or social). The impact of a higher protein diet on muscle quality, muscle fatigability, perceptions of fatigue and systemic inflammation in older adults has not been well documented. The utility of a higher protein weight loss diet combined with resistance exercise training to augment fat mass loss, attenuate lean mass loss and improve muscle quality and physical function could potentially be of high value to overweight older women. The potential further benefits of this regimen to enhance mental energy and other aspects of psycho-social well-being are unknown. The aims of the present study include assessing the effects of the proposed diet and exercise intervention on 1) body composition, 2) strength and muscle quality, and 3) energy and fatigue symptoms.
The purpose of this graduate student research study is to provide healthcare professionals with evidence of the potential of circuit strength training in improving the physical and psychosocial well-being of postmenopausal women.
This is a phase 1b investigator-initiated clinical trial that will evaluate the safety and feasibility of E-CEL UVEC® cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair. Allogeneic E-CEL UVEC cells will be delivered to the tendon repair site and to the muscle adjacent to the tendon repair site.
This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.
To highlight the importance of protein quality rather than the total protein content of a meal, the investigators will demonstrate that unlike high quality proteins, a single meal containing 30 g of an incomplete protein source does not stimulate skeletal muscle protein synthesis. Secondly, the investigators will directly challenge a prevalent, but untested, assertion that has the potential to negatively impact health. The goal is to demonstrate that complementary plant-proteins (i.e., two or more incomplete protein sources) must be consumed at the same meal to stimulate protein synthesis.
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
The optimal EAA-containing protein format necessary to maximally stimulate muscle protein synthesis and optimize whole-body net protein balance during caloric deprivation has not been determined. This study will address that gap in knowledge by examining post, whole-body exercise muscle and whole-body protein kinetic responses to ingesting varying EAA-containing protein formats after a 5 day period of negative energy balance. This study will provide the initial evidence to support the development of a recovery-based food product for military combat rations.
Individuals with spinal cord injury (SCI) often suffer from pain and spasticity. Traditional treatments for both of these conditions have been medications. However, it has been suggested that the counterstrain osteopathic manual manipulation treatment can decrease pain and possibly spasticity. The aim of this study is to investigate the effects of counterstrain osteopathic manual manipulation treatment on pain and spasticity in individuals with SCI.
The purpose of this study is to characterize the functional status and quality of life of patients undergoing Targeted Muscle Reinnervation (TMR) at time of major limb amputation (primary) or subsequent to major limb amputation (secondary). Participants can expect to be on study for about a year and will complete a short electronic survey and option phone interview.
Decreased muscle mass (sarcopenia) and strength (dynapenia) are common during aging, with a rate of muscle mass loss that is approximately 6% per decade between 30 and 70 years of age. Muscle mass loss results in reduced strength and physical function (frailty), increased risk for falls and bone fractures, and decreased quality of life. The age-related decrease in testosterone plays a key role in the loss of muscle mass and strength for aging males. There is increasing interest in nutritional and exercise strategies to prevent aging-related losses in muscle mass and strength. Sexual dysfunction has a high prevalence among men (31%), and include erectile difficulties (10%), lack of interest in sex (9%), and inability to achieve orgasm (7%). There are multiple causes including low testosterone. There is growing interest in natural supplements, and this study will compare under double blind procedures two natural supplements with placebo (Men's Perfect Multi Formula and Andro Vitality) that have been formulated by Purity Products. The supplements contain micronutrients, plant extracts, and herbs, with the primary bioactives Rhaponticum carthamoides and magnesium. Rhaponticum carthamoides, commonly known as maral root or Russian leuzea, is a perennial herb that grows in South Siberia, and has been used to enhance muscular and sexual function, but more evidence from properly designed human trials is needed to determine both efficacy and safety. The purpose of this study using a randomized, parallel group design, is to evaluate the effect of two supplements relative to placebo on strength, serum free and total testosterone levels, sexual function, mood state, and quality of life compared to placebo over a 6-week period in 120 males.
This randomized clinical trial studies how well expiratory muscle strength training works in improving bulbar function and quality of life in patients with head and neck cancer. Expiratory muscle strength training may help to strengthen the muscles involved in breathing and swallowing and may allow improved breathing, airway safety, swallow function, and quality of life in patients with head and neck cancer.
This research trial studies quality of life after bladder-preservation chemotherapy and radiation therapy (chemo-radiotherapy) in patients with bladder cancer that has spread into or through the muscle layer of the bladder (muscle-invasive bladder cancer). Bladder-preservation chemo-radiotherapy is a standard treatment for patients with muscle-invasive bladder cancer, however, chemo-radiotherapy may cause urinary tract, bowel, and sexual late side effects that negatively affect patients' quality of life. Studying quality-of-life in patients with muscle-invasive bladder cancer after chemo-radiotherapy may help identify the long-term side effects of treatment and may help plan the best treatment in the future and improve patients' quality of life.
This study is an observational study that aims to advance our knowledge on infantile onset FSHD. The study will include 50 participants of all ages who have presented with symptoms of FSHD between birth and 10 years of age. Study participation will involve a single day of assessments at one of the participating CINRG centers (to include physical exam, cognitive testing, eye exam, hearing test, strength testing and speech evaluations). The procedures may be split over additional days for scheduling purposes.
The purpose of this study is to determine if a lower extremity strengthening program as part of pulmonary rehabilitation will improve quadriceps muscle strength, endurance and functional status as well as overall quality of life. Hypothesis: 1. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quadriceps strength, endurance and functional capacity. 2. Lower extremity resistance training as part of a pulmonary rehabilitation program will improve quality of life in patients awaiting lung transplant.
The purpose of this study is to determine if the use of a respiratory resistance trainer will increase respiratory muscle strength, improve sleep quality and improve quality of life in individuals with spinal cord injury. Hypothesis: Use of the respiratory resistance trainer will improve respiratory muscle strength, improve sleep quality, and improve quality of life among individuals with spinal cord injury.
The purpose of this research study is to understand the walking patterns, strength and function changes of boys with Duchenne muscular dystrophy on/off corticosteroids to determine the best timing and treatment options to maintain walking for as long as possible.
This pilot study will examine the effect of testing order on test outcomes for measures of strength, dynamic balance, and movement quality. Each participant will perform a baseline test, then will perform the 6 iterations of the testing sequence.
As a function of the growing population of older adults, an estimated 3.48 million total knee arthroplasty (TKA) procedures will be performed annually in the U.S. by 2030. Despite the near-universal success of this surgery in mitigating chronic knee pain, TKA is not successful in restoring long-term physical function in older adults, primarily because of quadriceps muscle atrophy, which explains 77% of the strength deficits. Overall, strength and functional mobility in TKA patients is 30-50% below age-matched healthy controls. Functional tasks such as stair-climbing remain a clinical problem for 75% of patients following TKA. Muscle atrophy occurs in both operative and non-operative legs, and is essentially permanent for older patients because of their impaired ability to increase muscle mass. The purpose of this clinical research is to determine the effects of essential amino acid (EAA) supplementation on muscle mass, strength, and functional mobility following TKA in older adults. Based on strong preliminary data, the investigators hypothesize that twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA will increase basal rates of muscle protein synthesis via inactivation of catabolic signaling, and up-regulation of anabolic and cyto-protective proteins. The investigators further hypothesize that short-term atrophy prevention and accelerated return of functional mobility will lead to longer-term structural and functional adaptations, and improved quality of life in older TKA patients vs. Placebo. Identifying the mechanisms up-regulated by EAA treatment that preserve muscle volume and mobility will have a major impact on rehabilitation science. This study will accomplish two specific aims: (1) determine if EAA elevates basal rates of muscle protein synthesis by up-regulating anabolic pathways and cyto-protective proteins, and inactivating catabolic pathways in the short term vs. Placebo and (2) determine if short-term prevention of atrophy, weakness, and functional mobility leads to positive changes in muscle cell structure and function, and improved quality of life in the longer term vs. Placebo. This work is significant because it advances knowledge of the molecular and cellular changes occurring during muscle atrophy (Placebo) and atrophy prevention (EAA) in a clinical setting using a treatment that is broadly applicable, is well tolerated, and can be implemented immediately.
This is a phase III, multicenter, open-label, uncontrolled extension study in male subjects with DMD open to eligible US and Canadian subjects who previously participated in the following studies of drisapersen: DMD114876, DMD114044 and DMD114349. Subjects will receive 6mg/kg subcutaneous drisapersen on a weekly basis. For subjects who have previously experienced significant safety or tolerability issues or who experience these during the study, there is the potential of an alternate intermittent dosing arm that will be given as a regimen of 6 mg/kg weekly for 8 weeks followed by 4 weeks off treatment. For subjects who experience or have previously experienced significant safety/tolerability issues, side effects or reactions or intermittent dosing, intravenous dosing will be made available.