Clinical Research Directory

Abdominal and Core Exercises on Respiratory Functions in Obese and Overweight Women (COREBREATH)

This study aims to examine the effects of an 8-week Pilates-based exercise program on breathing functions in overweight and obese women (BMI ≥ 25). The program includes exercises for abdominal endurance and core stabilization, performed three times a week. Participants will be divided into two groups: an exercise group and a control group. Before and after the program, measurements will include lung function (spirometry), breathing rate, breath-holding time, abdominal mobility, core endurance (curl-up test), and quality of life (SF-36 questionnaire). The goal is to find out whether this type of exercise can improve breathing and overall health in women with excess weight.

Strength Training in Hospitalized Patients Using the Ghostly App: a Feasibility Study

The goal of this feasibility study is to evaluate the use of the Ghostly app in rehabilitation of stroke patients, elderly and patients recovering from COVID-19 or ICU patients. In three randomized controlled trials, the effect of a strength training program incorporated in the Ghostly app will be assessed for 1) stroke patients suffering from weakness of the lower limb, 2) frail elderly with gait difficulties and 3) patients recovering from COVID-19 or ICU patients who suffer from muscle weakness. Additionally, the effect of BFR on strength gain in all these three populations will be tested.

Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD

The goal of this clinical trial is to learn if targeted neuromuscular electrical stimulation (NMES) can treat respiratory and peripheral muscle weakness in patients with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are: * Does targeted NMES improve diaphragm thickening fraction and excursion as measured by diaphragm ultrasound? * What are the comparative effects of targeted NMES on plasma biomarkers, specifically Interleukin-6 (IL-6) and Insulin-like Growth Factor-1 (IGF-1)? Researchers will compare three groups: the first intervention group receiving intercostal NMES combined with Pursed-Lip Breathing (PLB), the second intervention group receiving quadriceps NMES combined with PLB, and a control group receiving sham upper trapezius NMES combined with PLB, to see if targeted NMES provides superior improvements in respiratory and peripheral muscle function. Participants will: * Undergo baseline screening, including a diaphragm ultrasound and a blood draw for plasma biomarkers (IL-6 and IGF-1) * Be randomly assigned to one of the three groups to receive either intercostal NMES, quadriceps NMES, or sham upper trapezius NMES, all combined with Pursed-Lip Breathing exercises * Complete a post-intervention assessment involving repeat ultrasound imaging and biomarker analysis to evaluate muscle and systemic changes

Effects of a Multidisciplinary Intervention on Muscle Strength, Posture, and Balance in Older Adults After an Earthquake

This randomized controlled trial evaluated the effects of a 12-week multidisciplinary intervention on muscle strength, postural alignment, and balance in older adults living in temporary container settlements following the February 2023 earthquakes in Kahramanmaraş, Türkiye. A total of 60 adults aged 65 years and older were allocated to an intervention group (n=30) or a control group (n=30). The intervention group participated in an individualized health management program that included exercises targeting muscle strength, balance, mobility, and posture, together with nutritional counseling, psychosocial support, and health education. The control group received no active intervention and underwent assessments at baseline and after 12 weeks. Muscle strength was assessed using digital and manual dynamometers. Postural alignment was evaluated using PostureScreen, while postural sway and balance were assessed using Gyko and functional performance tests, including the Timed Up and Go Test and Short Physical Performance Battery. The study aimed to determine whether a multidisciplinary intervention could improve physical function, postural alignment, and balance in older adults living in post-disaster temporary housing.

Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases

The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy. The primary objective of this study is to assess the safety profile, including any dose-limiting toxicity (DLT) and identification of a maximum tolerated dose (MTD) (if applicable), to support selection of the recommended Phase 2 dose (RP2D) of anito-cel when administered to participants with GMG.

Inspiratory Muscle Training Immediately After Lung Transplantation

Following lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life. Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease. The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.

Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty

The goal of this clinical trial is to compare two regimens of the pericapsular nerve group (PENG) block, an ultrasound-guided injection of local anaesthetic targeting the nerves supplying the front of the hip joint, for postoperative pain relief and quadriceps muscle function in patients undergoing primary unilateral total hip arthroplasty under spinal anaesthesia. The PENG block was originally proposed as a motor-sparing technique. However, the standard 20 mL volume can spread to the femoral nerve and cause quadriceps weakness. Reducing the injected volume may limit this spread and better preserve quadriceps strength, but smaller volumes risk shorter analgesic duration. Adding dexamethasone to a low-volume injection may compensate for the reduced volume. The main questions this trial aims to answer are: * Does a low-volume PENG block (10 mL bupivacaine 0.25%) with 4 mg dexamethasone differ from a standard-volume PENG block (20 mL bupivacaine 0.25%) in the time to first rescue analgesia? * Does it differ in the incidence and severity of quadriceps weakness on the operated side? Researchers will compare: * Group A (standard-volume PENG block): 20 mL bupivacaine 0.25%. * Group B (low-volume PENG block with dexamethasone): 5 mL bupivacaine 0.5% plus 4 mL normal saline plus 4 mg dexamethasone in 1 mL, giving 10 mL of bupivacaine 0.25%. Participants will: * Receive spinal anaesthesia with heavy bupivacaine 0.5% and fentanyl. * Be randomly allocated to Group A or Group B using computer-generated random numbers. * Receive the PENG block under ultrasound guidance, performed by an anaesthesiologist expert in regional anaesthesia. * Receive intravenous paracetamol 1 g every 8 hours, with intravenous nalbuphine 5 mg as rescue analgesia when the pain score (NRS) is 4 or more. * Be assessed by an anaesthesiologist blinded to group allocation for pain scores at rest and on movement at 2, 6, 12 and 24 hours; quadriceps strength (MRC scale and straight leg raise) at 6, 12 and 24 hours compared with the preoperative baseline; total opioid consumption over the first 24 hours; and time to first ambulation within the first 24 hours. The primary outcome is the time from completion of the PENG block to the first administration of rescue analgesia, recorded over the first 24 hours postoperatively. The study will be conducted at Ain Shams University Hospitals (El Demerdash Hospital) and will include 60 patients (30 per group), aged 50 to 70 years, ASA physical status I or II.

Exercise Training and Kidney Transplantation

The goal of this clinical trial is to investigate the physiological and molecular effects of exercise training in transplant recipients. The main questions it aims to answer are: 1. Can exercise training improve physical fitness and muscle strength in transplant recipients? 2. Can exercise training modulate inflammatory profile, hormones, lipid profile, and exercise-induced molecules in transplant recipients? 3. Can exercise training improve blood pressure and endothelial health in transplant patients? Participants will be invited to an exercise training program 6-month after their transplant surgery. Body composition, physical assessment, and blood draw will be assessed at baseline and 24-weeks after exercise or control regimen. Researchers will compare exercise group vs. routine care group to see if exercise training impact the health-related outcomes of this population.

Growth Differentiation Factor 15 in ICU Acquired Muscle Weakness

Intensive care unit -acquired weakness (ICU- AW) is a common consequence linked to a worse outcome as evidenced by prolonged mechanical ventilation, longer ICU stays, greater mortality rates and a lower quality of life for survivors, so early detection and treatment of ICU-AW are critical. However, there is no "gold standard" currently available for assessing and diagnosing ICU-AW. It's crucial to develop diagnostic methods that enable for early detection and risk stratification in all critically ill patients, such as: GDF-15 (growth differentiation factor-15) is thought to be a mediator of muscle atrophy because its level increases in the muscular atrophy As a result, measuring GDF-15 seems promise for diagnosing muscle atrophy.

Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance. In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme. Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients. The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training. This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.

Reliability of Cardiac Troponins for the Diagnosis of Myocardial Infarction in the Presence of Skeletal Muscle Disease

Visits to the emergency department (ED) for chest pain are extremely common and require a safe, rapid and efficacious treatment algorithm to exclude a possible AMI. These diagnostic algorithms are partly based on an important laboratory value, which showed growing utility in the diagnostic and prognostic of many cardiovascular diseases in the last years : cardiac troponin. However, some patients with muscle disease often present with unexplained elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in the absence of cardiac disease. The investigators aim at the characterization of the behaviour of this biomarker and its alternative (high-sensitive cardiac Troponin I), which will have important clinical implications on patients management.

Imaging Skeletal Muscle Mitochondrial OXPHOS Activity In Acute Lymphoblastic Leukemia Survivors

The participants are being asked to take part in this trial, because the participant is a survivor of childhood cancer or agreed to be part of a volunteer group to understand the relation between cancer and cancer treatment and muscle weakness in survivors of Acute Lymphoblastic Leukemia (ALL). ALL is cancer of the blood and bone marrow. Primary Objective • To compare muscle mtOXPHOS activity and satellite cell content among ALL survivors and controls. Secondary Objective * To evaluate the association between muscle mtOXPHOS, muscle satellite cell content and physical performance in ALL survivors. * To evaluate the association of muscle morphology and epigenetics with muscle mtOXPHOS in ALL survivors.

Patient Reported Recovery of Muscle Strength After Surgery for Cervical Radiculopathy, Impact of Duration and Severity on Recovery.

DCR surgery is generally recommended for patients with severe or progressive limb paresis. The incidence of motor weakness reported to be up to 70%, with a varying recovery rate up to 90%, and the prospects of recovery is most likely dependent on paresis severity and duration. Operative treatment could facilitate earlier recovery, but the evidence is weak and based on smaller and heterogeneous DCM/DCR populations. There is also a lack of knowledge concerning timing of surgery, i.e. the influence of paresis duration, surgical delay and preoperative paresis. It is also unclear if there is an association between the underlying DCR pathology (disc herniation, spondylosis or both) and prognosis. The aim of this sub-study is to assess the frequency and severity of limb preoperative paresis in patients operated for DCR, and to improve prognostication of recovery and timing of surgery. To the best of our knowledge, these issues have not been properly investigated previously. New knowledge in this field is highly sought by clinicians and can Inform patients, and physicians in shared decision making, i.e. helping them to choose more wisely between different treatment strategies. New insight in this field would be also be useful in clinical guideline development, for reducing surgical practice variation, for modifying outcome expectations, improve patient selection (clinical guideline development) and clinical outcomes of DCR surgery.

Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury

This randomized controlled trial will evaluate whether reallocating part of a fixed-duration supervised rehabilitation session to Wii Fit or Pilates will improve functional outcomes in adults with healed lower-extremity burns. Participants will be randomly assigned to Wii Fit, Pilates, or conventional rehabilitation and will receive 60-minute supervised sessions three times weekly for 12 weeks. Walking capacity, postural stability, functional mobility, and quadriceps muscle performance will be assessed at baseline, after the 12-week intervention, and 12 weeks after completion of supervised rehabilitation. The study will compare these time-matched rehabilitation approaches and will assess the persistence of functional changes during the subsequent follow-up period.

Muscle Aging Phenotypes in Childhood Cancer Survivors

Childhood cancer survivors experience premature declines in muscle mass, strength, and physical function that contribute to morbidity and early mortality. The biological mechanisms driving these impairments are heterogeneous and poorly understood. This observational study aims to characterize distinct muscle health endotypes in adult survivors of childhood cancer using advanced imaging, neuromuscular testing, and functional assessment. Survivors with reduced muscle health and community controls will undergo multimodal magnetic resonance imaging and spectroscopy, nerve conduction studies, surface electromyography, body composition assessment, and physical performance testing during a single study visit integrated into an ongoing cohort evaluation. Identifying mechanistic endotypes of impaired muscle health will support development of targeted interventions to preserve function and improve long-term outcomes in childhood cancer survivors. Primary Objective: \- Characterize reduced muscle health endotypes in childhood cancer survivors. Secondary Objective: \- Identify specific treatment and lifestyle related risk factors for each reduced muscle health endotype. Exploratory Objective: \- Host germline genetics will be associated with specific muscle endotypes.

Effects of Biofeedback-Guided Training on Muscle Strength and Postural Alignment in Upper Cross Syndrome.

This randomized controlled trial investigates the effects of biofeedback-guided training versus conventional therapy on muscle strength and postural alignment in patients with Upper Cross Syndrome. The study includes adults aged 25-45 years meeting diagnostic criteria for UCS, such as weak deep cervical flexors, restricted cervical ROM, forward head posture, increased thoracic kyphosis, and chronic neck pain \>3 months. Participants are divided into two groups: Group A biofeedback training and Group B conventional therapy, receiving 12 sessions over 4 weeks ,3sessions/week. Assessments are conducted at baseline, post-1st session, and weekly intervals using standardized measures.The study aims to compare the efficacy of biofeedback-guided training in improving strength and posture in UCS patients.

Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

Perianchor cyst formation is frequently observed after arthroscopic rotator cuff repair; however, its clinical significance remains unclear. This study aims to evaluate the relationship between anchor-related parameters and cyst formation, as well as their association with tendon healing and functional outcomes.

Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation

Patients in intensive care often develop acquired muscle weakness (ICUAW or Intensive Care Unit Acquired Weakness) due to immobilization and muscle atrophy. Early mobilization can help reduce weakness and improve functional recovery, but practices vary. Muscle strength assessment, particularly using the MRC (Medical Research Council) score, is crucial, though it has precision limitations. Additional methods, such as manual dynamometry and functional scales, are needed to better track muscle recovery. The quadriceps, important for function, requires early evaluation, but there is a lack of specific data in intensive care to predict medium-term functional recovery.

Muscular Rehabilitation by Eccentric Exercise After Severe COVID-19 Infection

With the COVID-19 pandemic, the number of patients to be treated in rehabilitation increased . Hospitalization for severe infection can induce muscular atrophy and muscular dysfunction that persists for several months and rehabilitation capacities may be exceeded. Exercises in eccentric mode could be performed, inducing greater muscular hypertrophy, muscle strength, power and speed than concentric exercises. The goal of this study was to compare functional recovery at 2 months after a training program in eccentric and concentric mode after severe COVID-19. An effective rehabilitation could help reduce costs and duration of care.

Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

People with cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their arms and legs. The NIH designed a new brace device, called an exoskeleton, that is worn on the legs and helps people walk. This study is investigating new ways the exoskeleton can be used in multiple settings while performing different walking or movement tasks, which we call ubiquitous use. For example, we will ask you to walk on a treadmill at different speeds, walk up and down a ramp, or walk through an obstacle course. Optionally, the exoskeletons may also use functional electrical stimulation (FES), a system that sends electrical pulses to the muscle to help it move the limb.

Comparative Effects of Different Inspiratory Muscle Training Modalities in Patients With Heart Failure.

The purpose of this study is to compare the effects of three different modalities of inspiratory muscle training (IMT) in patients diagnosed with chronic heart failure who exhibit reduced or mid-range left ventricular ejection fraction (LVEF \< 50%). Patients will be recruited from cardiac rehabilitation programs and must be clinically stable before entering the protocol. The study has a total duration of 8 weeks and is divided into two distinct phases. During the first 2 weeks, participants will undergo a familiarization phase to learn the proper breathing techniques with the devices and to complete baseline resting and functional clinical evaluations. The following 6 weeks will comprise the effective training phase, consisting of 3 weekly sessions of high-intensity inspiratory training. Participants will be randomly assigned to one of three parallel groups: * Group 1 (Pressure-Threshold IMT): Participants will train using a mechanical pressure-threshold device at an initial high-intensity load of 60% of their baseline maximal inspiratory pressure (MIP). * Group 2 (Electronic Flow-Resistive IMT): Participants will train at a high-intensity load of 60% of their baseline MIP utilizing the PowerBreathe KH2 electronic device, which provides a dynamic, flow-dependent automated resistance. * Group 3 (Control / Sham IMT): Participants will perform the same breathing protocol but using a mechanical device set at a low, non-training intensity of 15% of their baseline MIP. For all three groups, training volume is standardized to 5 sets of 8 repetitions (40 inspiratory efforts per session). To ensure progressive overload, training intensity will be increased by 10% of the initial baseline MIP value every 2 weeks. The main outcomes to be evaluated before and immediately after the 8-week period include maximal inspiratory muscle strength, structural changes in respiratory muscles (diaphragmatic and parasternal intercostal thickening fraction measured via ultrasound), cardiac autonomic balance (heart rate variability), and health-related quality of life. Additionally, dynamic responses such as respiratory and locomotor muscle oxygenation (measured continuously via Near-Infrared Spectroscopy \[NIRS\] during a respiratory metabolic reflex provocation test) and overall cardiopulmonary exercise capacity (measured via an incremental cycle ergometer test) will be analyzed. This study aims to determine which training modality provides the most effective physiological adaptations to optimize rehabilitation in this population.

Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes

Elderly patients who experience a prolonged ICU stay are at high risk for developing post intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic disability, prolonged mechanical ventilation and the need for costly extended stays in long term care facilities (LTCs). The investigators' preliminary study shows attempts at rehabilitating patients who have already developed PICS are minimally effective, resulting in only modest improvements in functionality. This project will determine the effects of mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing PICS related musculoskeletal and functional deficits, and improving clinical outcomes.

Muscle Recovery After Critical Illness

The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness: 1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments 2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors 3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission

NM Balance Regulation With ULLS and Loss of Sleep

The goal of this trial is to learn about how restricted sleep and not bearing weight on the leg affects muscle strength and posture control. Participants will walk exclusively on one leg, sleep at differing intervals, and complete posture tests, muscle strength tests, and muscle imaging. Researchers will compare adequate sleep and restricted sleep to see if muscle strength and posture are affected.