Active clinical trials for "Muscle Weakness"

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

The purpose of the study is to evaluate the safety and tolerability of switching from intravenous (IV) complement component 5 (C5) inhibitors to subcutaneous (SC) Zilucoplan in study participants with generalized myasthenia gravis (gMG)

The number of persons aged ≥60 years in the United States is expected to nearly double, from 57 to 109 million between 2010 and 2050. These demographic changes will have profound implications for the healthcare system because advanced age is associated with a heightened risk of negative health outcomes, including disability and frailty. Few therapeutic strategies currently exist to combat the age-related decline in physical functioning that stems from the progressive loss of muscle mass and strength. The goal of the proposed experiments is to determine the benefits of home-based leg heat therapy (HT) in old, sedentary individuals. This novel approach consists of trousers and a portable water pump. Hot water is circulated through the trousers, evenly heating the buttocks, thighs and calf. We propose to conduct a pilot randomized, sham-controlled trial in 20 sedentary, old individuals to establish the effect of daily home-based leg HT for 12 weeks on skeletal muscle size and function, walking performance and perceived quality of life. Participants will be asked to apply the treatment daily for 90 min using water-circulating trousers perfused with water heated to 42ºC (HT group, n=10) or 33ºC (sham group, n=10). The primary study outcomes is the change from baseline in 6-minute walk distance at 12-week follow up. Secondary outcomes include changes in calf muscle strength, as assessed using isokinetic dynamometry , sit-to-stand time, and calf muscle cross-sectional area, fat content and bioenergetics.

The primary objective of this phase III trial is to investigate if Rituximab can reduce patients' functional impairment caused by MG. The secondary objectives of this trial are to assess whether treatment with rituximab in patients with MG will: Allow faster and greater corticosteroid tapering Reduce the frequency of exacerbations Improve quality of life Offer an acceptable safety and tolerability profile.

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with refractory myasthenia gravis, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.

Rationale: Survival rates of patients with critical illness have increased due to improved facilities and treatment methods in the intensive care unit (ICU). However, surviving critical illness does not mean these patients are cured. In general, ICU-admission is associated with decreased physical performance and perceived physical health, impaired mental health and quality of life (QoL), reflecting in an impaired long-term recovery. Long-term health problems can partly be contributed to prolonged muscle weakness and malnutrition. Improving physical performance and perceived physical health may play a key role in boosting recovery after ICU-admission. Mono-interventions focusing on improving physical performance or nutritional intake have limited effect on long term functioning and QoL. A lifestyle intervention encompassing physical therapy and optimisation of caloric and protein intake may improve wellbeing and QoL in these patients. Previous studies found that interventions focused on mobilization and physical rehabilitation are feasible within the ICU and outpatient programs. Additionally, promising results were found in personalized healthcare and lifestyle programs for other patient groups with long-term health problems, such as cancer survivors and patients with diabetes or mental health problems. Based on this, the investigators hypothesized that a lifestyle intervention program may improve wellbeing and quality of life in long-term ICU-survivors. Objective: Evaluation of the effects of a integrative lifestyle intervention program on physical performance and perceived physical health, mental health and health related quality of life after ICU-admission. Study design: Randomised controlled trial Study population: Long-term ICU patients (length of stay ICU ≥48h) Intervention: The intervention group will be part of a 12-week combined lifestyle intervention encompassing group physical therapy twice a week and improvement of dietary caloric and protein intake by means of nutritional advice and, if applicable, caloric and/or protein supplementation. The control group will be subject to follow up meetings with research staff to assess physical and mental health and quality of life. Main study parameters/endpoints: Physical functioning (RAND-36 subscale-score) at the end of the 12 week intervention period. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All participants have two additional appointments where they participate in an interview and perform physical tests (bioimpedance measurements, ultrasound of the upper thigh muscles, hand grip strength test, Morton mobility index test, and the six-minute walking test with pulse oximetry). At baseline and week 12 of the program, all participants complete a combination of questionnaires on mental health and quality of life. The intervention group will additionally be subject to supervised group training sessions twice a week for the duration of the intervention (12 weeks). Further, two meetings with a professional about their diet will be organised. If a patient has a deficit in caloric and/or protein intake, dietary supplements with daily intake instructions will be provided. The risks and disadvantages of this intervention are minimal. However, this study requires considerable time investment and physical and mental effort. The extent of this study is crucial to clarify the effect of a combined intervention program on recovery after critical illness.

Myasthenia Gravis (MG) is a chronic autoimmune neurological disorder where an antibody attack of muscle receptors causes fatigable skeletal muscle weakness. In addition to fatigue, several MG patients experience general fatigue. Small supervised studies during 12 weeks of physical exercise interventions have indicated safety and beneficial neuromuscular outcomes in MG patients. Longer and unsupervised studies are required to obtain guidelines for physical activity in MG patients. Further, the development of smart rings enables remote digital supervision of physical activity, sleep, and biological parameters such as heart frequency, number of steps, and temperature. These parameters could add to the lack of biomarkers in MG. The project design is a randomized controlled trial with a lifestyle intervention to improve fatigue in the autoimmune neuromuscular disease Myasthenia Gravis (MG). The intervention includes digital group counseling regarding physical activity, sleep, general health, and digital follow-up with a "smart ring" (OURA).

This is a phase II, single center, randomized, double-blind, placebo-controlled, study in patients with a diagnosis of anti-AchR antibody positive myasthenia gravis.

Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).