Clinical Research Directory

Electromyostimulation (EMS) of Astronauts in Spaceflight (Easymotion-2)

This is a prospective spaceflight study involving an investigational non-risk device called the EasyMotionSkin for whole body electric muscle (myo) stimulation (WB-EMS) onboard the International Space Station (ISS). The purpose of this study is to show: * optimized exercise outcome with EMS in human spaceflight * demonstrate efficacy of EMS as alternative inflight exercise protocol * provide a time-saving and reliable EMS-assisted exercise protocol compliant to astronauts for later use in planetary habitats and future deep space exploration Eight (n=8) astronauts on long duration missions will take part in this study. This experiment uses the following hardware/software (HW \& SW): (A) EasymotionSkin suit (dry electrode muscle stimulation), B) non-invasive hand-held Myoton device (digitized passive muscle stiffness data collection). C) a customized Myoton body template suit (elastic yoga suit with customized anatomical reference labels to aid inflight Myoton data collection on dedicated perforated 2x2 cm small skin fields) at 5 different skin measurement points (MP), neck, back, shoulder, legs. Before and after flight the following tests will be done once: Myoton data collection, dynamometry strength test, magnetic resonance imaging (MRI) for baseline comparison. Researchers will compare data from a non EMS control group (non EMS Astronauts, retrospective) to see if changes of passive muscle stiffness is seen in EMS Astronauts before, during and after spaceflight

Improved Muscle Metabolism by Combination of Muscle Activation and Protein Substitution ( IMEMPRO )

Intensive Care Unit Acquired Weakness (ICUAW) describes muscle weakness that occurs in around 40% of patients during an intensive care stay. The morbidity and mortality of these patients is significantly increased over a 5-year period. The aim of this study is to investigate the combined effect of early enteral high-protein nutrition and early muscle activation on muscle atrophy in critically ill patients. The study will include 40 patients (20 intervention, 20 observation) with requirement for enteral nutrition at time of inclusion. In the intervention group the maximum possible level of mobilization is carried out and muscles are activated twice a day using neuromuscular electrical stimulation (NMES). The nutrition plan of the intervention group is based on the applicable guidelines for intensive care medicine with exception of increased protein intake. The control group receives therapy without deviating from the standard according of the DGEM guideline. The study aims to show that the decrease in muscle mass is significantly less than in the control group (primary hypothesis) via ultrasound of the rectus femoris muscle and in case of given consent muscle biopsy. As secondary hypothesis it is examined whether the combination of early high protein intake and muscle activation improves muscle strength and endurance.

The Role of Blood Flow Restriction Therapy in Postoperative Elderly Patients With Hip Fracture

The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age \>= 65) after recovering from surgical treatment of hip fractures.

Role of Metformin on Muscle Health of Older Adults

Muscle atrophy and insulin resistance are common after bed rest in healthy older adults. Metformin treatment has been shown to improve insulin sensitivity and attenuate muscle loss in insulin resistance adults though the mechanisms are not fully known. Metformin used as a preventive strategy to maintain muscle and metabolic health in bed ridden older adults has not been investigated.

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.

Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.

Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.

An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis

FIT Exercise in 30d of ULLS-induced Muscle Disuse

This study aims to determine how flywheel-based inertial training (FIT) implemented according to principles of velocity-based training (VBT) and High-Intensity Interval Training (HIIT) affects disuse-induced physical de-conditioning including loss of voluntary muscle strength, aerobic capacity, and balance regulation.

Intertrochanteric Femur Fracture Patients Who Receive Metformin With a Placebo

The investigators central hypothesis is that metformin supplementation will be well-tolerated, safe, and provide patients with improved functional and muscle morphology outcomes following intertrochanteric femur fracture. The objectives will be tested in older adults that sustain a hip fracture and are randomized to receive a daily oral dose (1.5g daily) of metformin or a non-active placebo during 4 months of recovery following surgery.

Identifying Fundamental Mechanisms of Skeletal Muscle Ageing in Older Men Undergoing Androgen Deprivation Therapy: a Feasibility Study

To find out whether it is possible to run a study looking at the underlying markers of ageing in muscle quality and quantity in men receiving Androgen Deprivation Therapy for prostate cancer treatment. To determine the feasibility of conducting an observational study examining the association of fundamental biological markers of ageing with changes in body composition and skeletal muscle morphology following ADT in older men undergoing prostate cancer treatment.

Continuous Passive Motion to Prevent Ankle Contracture and Muscle Atrophy in Ventilated Patients

This clinical trial aims to evaluate whether continuous passive motion (CPM) can prevent ankle joint contracture and muscle atrophy in critically ill patients receiving mechanical ventilation in the ICU. The study will also assess the feasibility and safety of implementing CPM therapy in this population. The primary objectives are: To determine whether CPM preserves ankle dorsiflexion range of motion during ICU immobilization. To assess whether ultrasound can detect changes in tibialis anterior muscle morphology in response to CPM. In this within-subject design, each participant will receive CPM therapy on one ankle while the contralateral ankle serves as the control. Outcomes related to joint mobility and muscle condition will be compared between the two sides. Participants will: Receive CPM treatment on one ankle for 30 minutes, twice daily, for up to 7 days or until ICU discharge. Undergo goniometric and ultrasound assessments at baseline and after the intervention. Continue to receive standard ICU care throughout the study period.

Postoperative Electrical Muscle Stimulation Two

Undesirable loss of skeletal muscle mass (atrophy) is a common feature of many diseases as well as ageing, bed rest and physical inactivity. Losing muscle can lead to a reduction in one's ability to perform physical activities, and reduce independence and overall health. Muscle mass loss occurs very quickly (i.e., within a few days) after surgery. The investigators previous work has shown that neuromuscular electrical stimulation (NMES) of the thigh muscles on one side of the body can help maintain muscle mass and strength on the stimulated side after surgery. Since then, additional work has been carried out to find the most effective form of stimulation to build muscle. The current study aims to use this refined stimulation protocol in a clinical trial on the wards after major abdominal surgery. The intervention will involve delivering stimulation to both thighs in the few days after surgery, so that the investigators can assess whether this stimulation can preserve muscle mass and strength, and also, patients' ability to perform physical activities after surgery. In addition, the study will aim to find out whether any benefit provided by electrical stimulation can be increased further by taking a protein supplement at the same time.

Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure

This study aims to determine, via skeletal muscle ultrasound (US), the extent, timing and relationship between skeletal muscle mass loss and outcomes after orthotropic heart transplantation (OHT) and left ventricular assist device (LVAD) implantation amongst patients with cardiogenic shock. Advanced therapies such as OHT and VADs in the heart failure (HF) population may promote skeletal muscle mass and subsequent quality of life, but there is a lack of literature assessing muscle mass changes in HF patients before and after advanced therapies using US imaging. Therefore this observational study will provide further insight into the 1) changes in lean body mass during critical illness and 2) the feasibility of using bedside US to assess lean body mass in the inpatient setting.

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.

Impacts of Mechanistic Target of Rapamycin (mTOR) Inhibition on Aged Human Muscle (Rapamune)

As people age, muscle mass and function is lost and exercise training is an important way to reduce the effects of this and remain independent. However, not everyone can perform this exercise and the muscle responses to exercise are often reduced in older people. So far there has been no drug found to specifically treat or reduce this problem. Muscle size depends on the balance of muscle protein breakdown and synthesis (building). This balance is regulated by multiple signals within the body, but a particular molecule - the mechanistic target of rapamycin (mTOR), is known to play an important role. For protein synthesis to build up the muscles, this pathway is needed to start the process when triggered by eating protein or exercise. Although this would suggest that mTOR activity is good, excessive levels of this signalling seem to have negative impacts on muscle maintenance with age. In animal studies, blocking mTOR signalling has stopped the development of a number of age-related diseases and increased health-span. Drugs that block this pathway (e.g. Rapamune) reduce the stimulation of muscle protein synthesis, possibly through changing the immune system, but conversely have also been shown to increase muscle size and reduce markers of nerve supply loss. This means that drugs which block the mTOR pathway could, in older people, help to reduce the negative impacts of excessive mTOR signalling on muscle size and function. The investigators aim to recruit 16 healthy male volunteers over 50 years old to investigate how the drug Rapamune (which blocks the mTOR pathway) affects aged human muscle both on its own and when combined with resistance exercise training.

The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty

Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.

Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

Residual limping after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate a surgical treatment for residual limping and compare its results with non-surgical treatment. Our hypothesis is that surgical treatment followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.

Body Composition Study in Critically Ill Patients-Extended to COVID-19

Muscle loss (ultrasound quadricep muscle) and muscle strength (handgrip and knee extension strength) will be compared between COVID-19 and non COVID-19 critically ill patients.

The Role of Type 2 Diabetes on Skeletal Muscle Atrophy and Recovery Following Bed Rest in Older Adults

The goal of this study is to determine the impact of pre-diabetes and type 2 diabetes on muscle atrophy during a period of bed rest and recovery of muscle mass, strength, and physical function following bed rest.

The Impact of Energy Intake and Short-term Disuse on Muscle Protein Synthesis Rates and Skeletal Muscle Mass in Middle-aged Adults.

In healthy middle-aged men and women, what is the effect of dietary energy restriction and energy surplus on daily muscle protein synthesis rates and muscle morphology, compared to energy balance, during free-living and immobilisation?

Neuromodulation for Prevention of Intensive Care Unit Acquired Weakness and Post Intensive Care Syndrome

Post-intensive care syndrome (PICS) encompasses persistent physical, cognitive, and psychiatric symptoms following ICU discharge, commonly triggered by serious conditions such as respiratory failure, sepsis, and mechanical ventilation. PICS prevalence is reported to be as high as 84% up to 12 months in patients with at least 2 days spent in the ICU or with mechanical ventilatory support. As a consequence, many patients do not return to they former level of function for weeks, months and even years. Muscular affection manifested by muscle weakness is particularly seen and is provoked by a combination of damage to the nerves or directly the muscles fibers. This affection is referred to as CU-Acquired Weakness (ICUAW). One third of the time, lower extremities are affected, often due to prolonged immobilization or sedation. Evidence suggests that early mobilization reduces the incidence of ICUAW at discharge and improves the number of patients able of stand. However achieving this early intervention is not always feasible due to time or personnel constraints. The purpose of the study is to examine the effectiveness of lower extremity neuromodulation for prevention of muscle deconditioning in patients admitted to the ICU.

Impact of NMES and HPRO on Recovery After SAH- Pilot Study

The study purpose is to investigate the hypothesis that in adults with SAH, early neuromuscular electrical stimulation (NMES) and high protein supplementation (HPRO) will improve muscle mass, metabolic and inflammatory biomarker profiles, compared to SAH controls receiving standard of care interventions for nutrition and mobilization. The investigators will accomplish this by studying the effects of a high protein (HPRO) nutritional treatment as well as NMES intervention have upon muscle wasting and motor strength acutely after SAH. This will be addressed in a prospective trial of SAH patients receiving HRPO with NMES as compared to age and severity-matched SAH patients undergoing standard of care interventions for nutrition and mobilization. Additionally, the study will investigate the impact HPRO and NMES interventions have upon inflammatory cytokines and markers of energy balance. Results of this study will establish evidence for precision nutrition plus early exercise to mitigate the catabolic and inflammatory state produced by SAH to improve muscle, metabolic, and health recovery outcomes.

Achilles Tendon Rupture - Intervention With Electrical Stimulation

Acute Achilles tendon rupture (ATR) is an injury that is commonly associated with complications, such as blood clotting, muscle loss and tendon lengthening, all of which affect the long-term outcome and return to sports. These complication are related to the treatment of ATR with lower leg immobilization in a boot. The investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation (C-NMES) during leg immobilization after ATR can 1) reduce blood clots, 2) lower the degree of muscle loss, 3) decrease tendon lengthening and 4) improve long-term outcome.

Essential Amino Acid Supplementation for Femoral Fragility Fractures

This trial will evaluate the impact of 4 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 6 months after injury. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation.