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Muscular Atrophy clinical trials

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NCT ID: NCT06032247 Withdrawn - Clinical trials for Anterior Cruciate Ligament Injuries

Bilateral Versus Unilateral Strength Training After ACLR

BUST
Start date: August 31, 2023
Phase: N/A
Study type: Interventional

After rehabilitation completion, there remains large deficiencies between the operative (OP) and non-operative (NOP) limbs in lower-limb outcomes (e.g., size, strength, and function) and these deficits can persist for years. Therefore, further specialized training protocols, such as the ones in the present study, are required to determine if these deficits can be lessened. The proposed project will evaluate the effect of 8-weeks of single-leg and double-leg lower-body resistance training on musculoskeletal function in individuals with a previous anterior cruciate ligament (ACL) reconstruction (ACLR) in a randomized control trial. The study will recruit 30-40 males and females between 18-35 years of age that have undergone a previous ACLR. Participants will be randomized to either the single-leg/unilateral (UL) or double-leg/bilateral (BL) training groups. Training will occur three times per week for 8-weeks. The UL group will participate in exercises such as split squats, single-leg deadlifts, or single-leg squats. The BL group will utilize exercises such as double-leg squats, conventional deadlifts, and leg presses. One week prior to (PRE) and one week after (POST) the training program, all participants will undergo a testing battery. Musculoskeletal ultrasound will measure quadriceps and hamstrings muscle cross-sectional area (mCSA), fascicle length (FL), and pennation angle (PA) of both OP and NOP limbs. Strength will be assessed through maximal voluntary isometric contractions (MVIC) for the quadriceps and hamstrings, and one-repetition maximum tests for single-leg leg extensions, leg curls, and leg press. Lower-limb function will be assessed through single-leg and double-leg jumps on a dual force plate system for jump height, impulse, rate of force development, and peak force. Data will be analyzed via separate mixed-factorial analyses of variance for the within-subjects factor of leg (OP vs. NOP) and time (PRE vs. POST) and the between-subjects factor of biological sex (male vs. female) and group (UL vs. BL). Post-hoc analyses will include lower-order ANOVAs and t-tests as pairwise comparisons when significance is detected. Significance will be established at p≤0.05. The results of this study will assist practitioners, coaches, sport scientists, and most importantly, the athletes, in the development of post-rehabilitative strength training protocols designed to reduce between-limb discrepancies.

NCT ID: NCT05830214 Withdrawn - Healthy Clinical Trials

Digital Smartwatch Measurements as Potential Biomarkers for Remote Disease Tracking in ALS

Start date: January 2024
Phase:
Study type: Observational

This observational study will use new smartwatch technology to continuously and remotely monitor the health of ALS patients and healthy controls over time. This information will be used to develop digital biomarkers for ALS.

NCT ID: NCT05631418 Withdrawn - Recruitment Clinical Trials

Chinese Regional Spinal Muscular Atrophy Patient Registration Study

Start date: November 2022
Phase:
Study type: Observational [Patient Registry]

The primary objectives of this study are to obtain clinically meaningful data on the survival, outcomes, prognosis and treatment effect of all the patients with spinal muscular atrophy (SMA) 5q types 1 to 3 (according to international classification), being followed in the Children's Hospital, Zhejiang University School of Medicine since October 2019. The registry will collect retrospectively and prospectively the longitudinal data of the long-term follow-up for children patients, under real life conditions of current medical practice, in order to document the clinical evolution of patients (survival, motor, respiratory, orthopedic and nutritional and so on), the conditions of use of the treatments, the mortality rates of treated and untreated patients, the tolerance of the treatments, adverse events.

NCT ID: NCT05041114 Withdrawn - Clinical trials for Amyotrophic Lateral Sclerosis

SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Start date: April 21, 2022
Phase: N/A
Study type: Interventional

The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility. The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

NCT ID: NCT04105816 Withdrawn - Muscle Atrophy Clinical Trials

Ultrasound for Rectus Femoris Measurement

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Postoperative protocols for orthopedic procedures on the lower limb often require a period of immobilization to protect the surgical site. The consequence of this immobilization is muscle atrophy which can be severe, delaying a patient's return to activity and predisposing them to recovery complications or subsequent injury (1)(2). The current standard methods to assess lower limb muscle atrophy all have their respective limitations. Thigh circumference or isokinetic strength values are indirect measures of atrophy and can be inaccurate. Magnetic resonance imaging (MRI) of muscle cross-sectional area (CSA) is time-consuming and expensive. Computed tomography imaging of muscle CSA is expensive and exposes the patient to radiation (3). For these reasons, none of the current methods are ideal for regular use in the clinic. Musculoskeletal ultrasound is a promising measurement tool to assess muscle atrophy in postoperative patients. Ultrasound is non-invasive, cost-effective, does not involve radiation, and can give direct images of muscle size (4). Musculoskeletal ultrasound requires further research on its potential as an evaluation tool for postoperative lower limb orthopedic patients-specifically, whether ultrasound is a reliable and valid tool for quadriceps size measurements.

NCT ID: NCT04058977 Withdrawn - Critical Illness Clinical Trials

Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness

POWER
Start date: December 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Patients surviving critical illness experience significant skeletal muscle dysfunction and weakness. Muscle atrophy suffered during critical illness has a long-term impact on the functionality and mobility of these individuals. As a result, individuals surviving critical illness have a significant reduction in quality of life, even up to 5 years post discharge. Research including large randomized controls demonstrates that rehabilitation focused on active mobilization may positively influence patient outcomes. Thus, early mobilization is an important intervention that has many purported benefits. Current rehabilitation practice in the intensive care unit (ICU) and recommendations from clinical practice guidelines such as the Society of Critical Care Medicine, PADIS Guidelines support these interventions to reduce the detrimental effects of immobilization during critical illness. Early mobilization is routinely thought of as standard of care for patients admitted for acute respiratory distress syndrome and sepsis. However, a significant number of recent randomized controlled trials implementing early rehabilitation and mobilization interventions fail to demonstrate immediate or long-term benefits.10,11,18,19 Interesting, active mobilization and rehabilitation analyzed in systematic review had no impact on mortality and "no consistent effects of function, quality of life and ICU or hospital length of stay."18 There are a few potential explanations for interventions not leading to reduction in impairment or functional benefit. Scientific Premise: From our preliminary data (Figure 1) and my clinical experience, a significant cause of the physical impairments in these patients is reductions in muscular power. Muscular power is a critical determinant of functional mobility.20 Preliminary data demonstrate that lower extremity muscle power is significantly reduced in this population and furthermore, these deficits are strongly correlated to physical function. Muscle power training is a potential therapeutic intervention that could lead to more robust improvements in physical function. This concept has been explored extensively in community-dwelling older adults. A recent systematic review of controlled trials demonstrates that power training is superior to traditional resistance training at improving functional performance when comparing the two training modalities.21 Furthermore, power training is feasible for older adults and clinical populations of Parkinson's Disease, Stroke, and frailty.22-27 Thus the feasibility and pragmatic nature of power training is not a concern. Of interest, a randomized controlled trial was completed in institutionalized frail nonagenarians (>85 years or older).27 In this study, no patients drop-out of study due to power training and significant benefits in function were achieved.27 Therefore, the investigators propose a interventional trial to study the effect of a standardized muscle power training program for patients admitted to the ICU for critical illness.

NCT ID: NCT04050852 Withdrawn - Clinical trials for Spinal Muscular Atrophy

Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments

Start date: July 17, 2019
Phase: Early Phase 1
Study type: Interventional

It is well known that patients with spinal muscular atrophy (SMA) have progressive decline of respiratory muscle function. Therapy traditionally involved supportive means to ensure optimal nutrition and airway clearance. Nusinersen (spinraza) is a disease-modifying medication approved for treatment of SMA in pediatric and adult patients. The goal of this study is to observe pulmonary function test (PFT) changes and respiratory muscle strength trends throughout the first year of treatment. A prospective, longitudinal study measuring pulmonary function testing (PFTs) changes in spinal muscular atrophy (SMA) patients. Patients will be patients with SMA who are approved and maintained on nusinersen. Patient will have a baseline PFT. Investigators will repeat PFT at 3, 6, and 12 months while on nusinersen treatment.

NCT ID: NCT03794570 Withdrawn - ACL Injury Clinical Trials

BFR Therapy After ACL Reconstruction

BFR
Start date: December 18, 2018
Phase: N/A
Study type: Interventional

This study is a prospective, double-blinded, randomized control trial examining the effect of blood flow restriction (BFR) therapy on reducing post-operative quadriceps atrophy in patients undergoing anterior cruciate ligament reconstruction (ACLR). Following ACLR, patients will undergo a rehabilitation protocol either w/ BFR therapy or sham BFR therapy.

NCT ID: NCT03069781 Withdrawn - Muscle Atrophy Clinical Trials

The Effects of 17β-estradiol on Skeletal Muscle

Start date: May 2017
Phase: Early Phase 1
Study type: Interventional

The maintenance of skeletal muscle mass and function is critical for healthy aging. Muscle loss with disuse, termed muscle disuse muscle atrophy, leads to impaired functional capacity, the onset of insulin resistance, as well as a heightened risk for morbidity and mortality. With advancing age there is a chronic wasting of muscle. This is especially true in women, where rapid rates of decline in muscle mass and greater anabolic resistance are experienced around the time of menopause, despite higher protein synthesis rates. As women have a longer life expectancy, they are particularly venerable to age-related frailty and morbidity. Skeletal muscle protein turnover serves to maintain the optimal function of proteins and also provides plasticity of the tissue during altered demands such as during increased loading or unloading of the muscle. Reduced periods of physical activity also have a similar, albeit milder, impact on skeletal muscle and most, people will likely experience multiple bouts of skeletal muscle disuse during their lifetime from which some, particularly older adult women, will fail to fully recover. Thus, muscle disuse atrophy is a significant and continuing problem as reclamation of lost muscle mass, strength/function, and potentially metabolic health (particularly insulin-induced glucose disposal), following disuse is oftentimes incomplete and may be further exacerbated after menopause. Previous evidence has demonstrated that in the loss of muscle mass is less pronounced in post-menopausal women when receiving hormone replacement therapy. Skeletal muscle has estrogen-β-receptors on the cell membrane, in the cytoplasm and on the nuclear membrane, and therefore a direct mechanistic link between low estrogen levels and a decrease MPS. Interestingly, despite higher rates of protein synthesis, older women still lose muscle mass with advancing age. It has been suggested that the negative muscle protein balance is due to an enhanced rate of MPB. Insulin is a potent inhibitor of MPB and estrogen has been shown to enhance insulin sensitivity in skeletal muscle. However, to our knowledge, no study has examined the efficacy of estrogen supplementation to attenuate the losses of skeletal muscle mass and function during a period of disuse. The findings of this investigation may yield critical data for those who wish to combat skeletal muscle disuse atrophy, particularly after menopause.

NCT ID: NCT02958254 Withdrawn - Muscle Atrophy Clinical Trials

Ultrasound Measurements Hamstring Muscles Thickness

Start date: December 2016
Phase:
Study type: Observational

No previous studies have compared the association between muscle thickness (MT) and muscle cross-sectional area (CSA) in healthy volunteers. The main aim of this study is to investigate the validity of ultrasound in assessing the muscle thickness of hamstrings muscle. Study design: A cross-sectional-validity study. Setting: University Participants: X football players of an amateur football team (X healthy volunteers and X patients with a previous hamstring injury).