Clinical Research Directory

Plant-based Diets and Healthy Aging

This prospective study investigates the health effects of vegetarian and plant-based diets in middle-aged and older adults in Taiwan, specifically, recruiting 5000 Tzu Chi volunteers. Previous Tzu Chi cohorts found vegetarian diets were protectively associated with incidences of diabetes, stroke, gout, cataracts, insomnia, and gallstones, while reducing healthcare costs. The study also aims to clarify dietary patterns-particularly plant-based and vegetarian diets-and determine how potential deficiencies or excesses of various nutrients influence common aging-related health issues, including healthy cognitive decline, sarcopenia, and the risk of age-related diseases, in order to inform dietary and lifestyle recommendations that promote healthy aging and maintain physical function.

Pulmonary Rehabilitation in Advanced Non-small Cell Lung Cancer Patients

Lung cancer (LC) is usually diagnosed in advanced stages and continues to be the leading cause of cancer related deaths worldwide. Cancer cachexia are frequent among patients with LC affecting up to 80% of patients with advanced stage disease, and it has been related with higher risk of complications, length of hospital stay, and worst overall survival. During cancer cachexia, both muscle and fat mass can be wasted, however, the loss of muscle mass has been associated to higher treatment related toxicity, loss of functional status, shorter progression free survival and overall survival in different types of cancer under various treatments. Hence, preservation of muscle mass and function should be an important focus of the multidisciplinary treatment of patients with LC. Pulmonary rehabilitation (PR) has been known to improve pulmonary function, reduce fatigue and improve exercise tolerance in patients with LC undergoing curative surgery. However, few studies have focused on the efficacy of PR on patients with advanced cancer undergoing palliative care with chemotherapy or targeted therapies.

Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet

This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II clinical trial to determine the usefulness of nandrolone decanoate in a new indication (sarcopenia). Patients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive comprehensive physiotherapy and nutritional intervention. There will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (\< 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the upper and lower extremities (\< 20 kg in men and \< 15 kg in women) by densitometry.

Creatine Supplementation and Resistance Training to Improve Sarcopenia Parameters in Patients With Prostate Cancer After Androgen Deprivation Therapy

This randomized, double-blind, placebo-controlled clinical trial will investigate the effects of creatine supplementation combined with a 12-week supervised resistance training program on muscle mass, muscle strength, physical performance (e.g., parameters of sarcopenia), and muscle density in men with prostate cancer undergoing androgen deprivation therapy (ADT). ADT often causes loss of lean mass, reduced muscle strength, functional impairment, and increased fat mass. Eligible male patients will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) in a double-blind manner, in addition to participating in the resistance exercise program. Assessments will be performed at baseline and after the 12-week intervention period and will include: * Muscle density and architecture assessed by ultrasound * Body composition (lean mass and fat mass) * Muscle strength * Physical performance (functional performance tests) * Inflammatory biomarkers * Vascular function parameters The primary goal is to assess whether creatine supplementation combined with resistance training can safely improve muscle quality and quantity, strength, and physical function in these patients. If effective and safe, the intervention could help reduce muscle loss and improve quality of life in men undergoing ADT.

Determination of Skeletal Muscle Mass Index Values in the Turkish Population Using Dual Energy X-Ray Absorptiometry

Sarcopenia is defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as "a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, carrying a risk of adverse outcomes such as physical disability, fractures, falls, impaired quality of life, and death." However, despite the severity of the disease, a single diagnostic criterion has not yet been established, and various guidelines have been proposed to standardize the diagnostic criteria and cut-off values. Current European Working Group on Sarcopenia in Older People (EWGSOP) recommendations focus on European populations and, where possible, the use of normative references from healthy young adults. Since measurements such as gait and muscle strength are height-dependent, the use of regional normative populations is recommended whenever possible. Currently, some cut-off points for the diagnosis of sarcopenia are arbitrary. The development of validated cut-off points will depend on normative data and their predictive value for endpoints. Further studies are needed to determine whether gender-specific and region-specific threshold values for the diagnosis of sarcopenia improve the prediction of sarcopenia outcomes. There are no studies in the literature on dual-energy x-ray absorptiometry cutoff values specific to the Turkish population. In our study, we aimed to define reference cutoff values for muscle mass, muscle strength, and calf circumference in Türkiye in order to improve the general applicability of EWGSOP criteria.

Chronic Kidney Disease-related Sarcopenia With Poor Prognosis

Chronic kidney disease (CKD) has become a global public health priority over the past few decades, affecting 10-12% of the adult population and has received increasing attention. Sarcopenia describes a generalizes degenerative skeletal muscle disorder involving the loss of muscle mass, muscle function and/or physical performance. Indeed, Sarcopenia is a condition with many causes and it can be considered "primary sarcopenia" when no other cause is evident but ageing. While in the clinical practice, it also occurs in patients with chronic diseases, such as chronic kidney disease, which can be considered "secondary sarcopenia". Notably, the occurrence of sarcopenia in CKD patients is not only related with ageing, the accumulation of uremic toxins, inflammation, insulin resistance, malnutrition and oxidative stress also contribute to the muscle depletion. Moreover, sarcopenia increased risk of falls and fractures, impaired ability to perform activities of daily living, disabilities, loss of independence and increased risk of death. Hence, it is of great significance to prevent the occurrence and development of sarcopenia in patients with CKD. The purposes of this project were to investigate the prevalence of sarcopenia, further explore the risk factors for sarcopenia and detect the relationship between sarcopenia and outcomes in CKD patients.

Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults (M3AX)

Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments that compromise healthspan and quality of life. Exercise is a multipotent treatment with promise to mitigate most aging hallmarks, but there is substantial variability in exercisƒe responsiveness. Combining endurance and resistance training in alignment with public health guidelines will be used to better understand variable exercise responsiveness in older adults with the ultimate goal of improving each older adult's capacity to attain the many health benefits of exercise.

Personalized Cooking and Nutrition Guidance and Physical Activities Program to Reduce Muscle Loss in Advanced Cancer

People with advanced cancer often lose muscle over time. This can make them weaker, more tired, and reduce their quality of life. Many patients also struggle to eat because of changes in taste, smell, or appetite. This study evaluates a new way to help slow muscle loss and support daily functioning. The approach combines personalized food and cooking guidance with close nutrition demands support. The goal is to help patients eat better in a way that fits their personal needs. It is hypothesized that this close, personalized treatment improves muscle loss and the quality of life of adults with advanced cancer who are receiving chemotherapy. The study focuses on people with mild to moderate muscle mass loss currently undergoing or about to start chemotherapy and aims to slow further decline in their muscle mass. The approach is designed to be practical and suitable for everyday life during cancer treatment. About 200 adults with advanced cancer who are receiving, or about to receive, chemotherapy will take part in this study. The study will take place at the Davidoff Cancer Center in Israel and will last 6 months. Participants will be randomly assigned to one of two groups. One group will receive standard nutrition care from dietitians as well as ongoing physical activities programing and monitoring. The other group will receive the same care, plus personalized cooking and food guidance tailored to their taste and smell changes. This group will also receive care based on careful measurements of their body's energy needs, body composition, and muscle strength. These measurements will help the dietitian to offer more precise and personalized nutrition guidance over time. Both groups will also receive advice about physical activity. Researchers will follow changes in muscle strength, physical function, nutrition status, and quality of life during the study. The results will help determine whether personalized food and cooking support can better protect muscle mass and well-being in people with advanced cancer.

Tele-Rehabilitation in Adults With Cystic Fibrosis

This study is a randomized controlled trial designed to evaluate the effectiveness of an 8-week tele-rehabilitation program in adults with cystic fibrosis. Cystic fibrosis is a chronic condition that affects the lungs and can lead to reduced muscle mass, physical weakness, frailty, and decreased quality of life. Participants will be randomly assigned to either a tele-rehabilitation group or a usual care group. The tele-rehabilitation program includes supervised exercise sessions conducted remotely three times per week using video communication. The program combines aerobic and resistance training based on established rehabilitation guidelines. The primary aim of the study is to assess the effect of the program

Multimodal Training Effects in Middle-Aged and Older Adults With Diabetic Sarcopenia

This study aims to investigate the effects of a 12-week multimodal exercise intervention on middle-aged and older adults (aged 45\~85 years) with Type 2 Diabetes Mellitus (T2DM). The program combines supervised training, home-based sessions, and digital support to improve muscle function, physical performance, metabolic control, and quality of life.

Multimodal Nutritional and Sarcopenia Assessment for Risk Stratification in Lung Cancer Surgery

This prospective observational cohort study aims to evaluate the prognostic value of multimodal nutritional status and sarcopenia assessment in patients undergoing lung cancer surgery. Postoperative complications, mortality, and prolonged hospital stay remain major clinical concerns in thoracic surgery. Although malnutrition and sarcopenia are recognized as important determinants of surgical outcomes, their combined and multidimensional evaluation has not been sufficiently studied. Adult patients undergoing anatomical lung resection for primary lung cancer will be included. Nutritional status will be assessed using serum biomarkers, inflammatory indices, and validated clinical nutritional scores. Sarcopenia will be evaluated using computed tomography-based muscle mass and density measurements, as well as ultrasonographic muscle thickness. These parameters will be analyzed in relation to postoperative complications, intensive care unit (ICU) requirement, length of hospital stay, and mortality. Multivariable analyses will be performed to identify independent predictors, and a combined risk stratification model will be developed. This study aims to improve preoperative risk assessment and to support personalized perioperative management strategies, including identification of patients who may benefit from targeted nutritional optimization and prehabilitation.

Exercise for the Treatment of Cancer-Related Sarcopenia

Our primary objective is to assess the effects of exercise on cancer-related sarcopenia and its hallmarks, including muscle strength, muscle mass, and physical performance. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (QoL), cancer-related fatigue, and sleep quality. Additionally, we will explore the effects of exercise on bone and fat mass as secondary outcomes.

Effects of Functional Task Training on Muscle Health and Function in Older Adults With Sarcopenia

Sarcopenia is a condition associated with aging that causes a loss of muscle mass, strength, and physical function. This decline limits the ability to perform basic daily activities and increases the risk of falls and dependency. The purpose of this clinical study is to determine the effects of a 12-week Functional Task Training (FTT) program on functional, structural, and physiological biomarkers in older adults with sarcopenia. FTT involves practicing everyday movements, such as standing up from a chair, climbing stairs, walking, and carrying objects. The study aims to answer the following question: Does Functional Task Training performed specifically in optimal muscle power zones offer greater improvements in aging biomarkers compared to standard Functional Task Training or traditional resistance training? The researchers hypothesize that while all exercise interventions will be beneficial, the FTT program focused on power zones will generate the greatest improvements in functional, physiological, and structural biomarkers in older adults with sarcopenia. To test this, 30 older adults (aged 60 and older) will be randomly assigned to one of three active groups for a 12-week period (2 days per week): an FTT group training in power zones, a standard FTT group, or a traditional resistance training group. All exercise groups will use a Functional Electromechanical Dynamometer (DEMF) to precisely measure and control the training loads.

HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke

The aim of this study is to investigate the effect of post-stroke sarcopenia on prognosis and clinical outcomes in patients with ischemic stroke and to compare the effects of High Intensity Interval Training (HIIT) and Moderate Intensity Continuous Training (MCIT) exercise programs on muscle mass, as well as on functional capacity, quality of life, and clinical outcomes.

Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly

The ageing population makes it necessary to find effective strategies for the prevention of sarcopenia (the progressive loss of muscle mass and strength and a decline in physical performance) that can be counteracted with foods containing protein and adequate intake of vitamin D. This study will evaluate the effectiveness of consuming a food based on plant proteins and vitamin D supplementation. Intervention studies in humans conducted to date have mostly focused on the effect of animal proteins (mainly from whey) on disease progression. A study on the effect of pea proteins has not yet been conducted and will provide information on the effectiveness of these proteins in modulating markers linked to the disease. The effect on the gut microbiota will also be considered, as the existence of a gut-muscle axis has been suggested, in which microbial genera producing short-chain fatty acids have been linked to a positive effect on muscle mass through anabolic stimulation. Thus, the analysis of the modulation of the intestinal microbiota, through the dietary intervention proposed in this study, may represent a further step in research related to the prevention of this disease. Sarcopenic volunteers aged between 65 and 80 will be recruited to consume either a shortbread biscuit made with wheat flour enriched with hydrolysed pea protein and a vitamin D supplement in extra virgin olive oil, or a control biscuit and a placebo (extra virgin olive oil) for 12 weeks. The study will be randomised, parallel, single-blind. The effect of consuming the experimental biscuit and vitamin D supplementation compared to that of a traditional control biscuit and a placebo oil solution will be evaluated on certain markers related to sarcopenia. In particular, the following will be considered: muscle strength, measuring grip strength and leg strength (chair stand test); muscle mass through the measurement of appendicular muscle mass, and the calculation of the appendicular muscle mass index; physical performance using the Short Physical Performance Battery; the inflammatory response and other blood biomarkers related to sarcopenia. In addition, the following will be assessed: dietary habits through a food diary and quality of life through the SarQoL questionnaire. Finally, the effect of nutritional intervention on the modulation of the gut microbiota will be evaluated through 16S rRNA sequencing and bioinformatic analysis of the data.

Effect of Essential Aminoacid Supplementation and Exercise on Skeletal Muscle Function in Hemodialysis Patients

Sarcopenia can be easily observed in patients with hemodialysis. However, there were few studies on the precise concept and diagnostic criteria for sarcopenia in patients with hemodialysis. The investigators have already recognized the sarcopenia-associated mortality and morbidity in patients with hemodialysis. However, intervention studies on hemodialysis patients with sarcopenia have not been conducted until now. In 2021, the investigators conducted a pilot study to evaluate the effectiveness of the combined exercise and nutrition intervention for sarcopenia in patients with hemodialysis to confirm the effectiveness. This study is a follow-up study, conducted as a randomized controlled trial.

The Influence of Movement Velocity Biofeedback on Muscle Activation and Self Perception in Older Adults With Sarcopenia

The overall objective for this clinical trial is to provide evidence for internal and external cueing for physical therapists and other rehabilitation clinicians to optimize resistance training within rehabilitation for older adults. The main questions it aims to answer are: * What is the impact of external focus (providing velocity of movement for each repetition) compared to internal focus (i.e., no cues, control group) on physical percent velocity loss and neuromuscular activation in older adults with sarcopenia? * Does internal and external focus influence motivation and perceptual workload following resistance training in older adults with sarcopenia? Researchers will compare external focus to internal focus to see if external focus impacts percent velocity loss, motivation, and perceived workload. Participants will: * Visit the lab once per week for 3 weeks * Perform exercise testing using a leg press * Answer questionnaires regarding perceived workload and motivation before and after exercise

Muscle-Specific Multimodal AI for Sarcopenia Diagnosis

This study aims to develop a muscle-specific multimodal artificial intelligence (AI) model for the diagnosis of sarcopenia and to investigate the effects of rehabilitation training on muscle aging. Clinical, functional, and imaging data will be collected from participants with muscle function decline. Multimodal data, including muscle function measurements and clinical assessments, will be integrated to develop and validate an AI-based diagnostic model for sarcopenia. In addition, the effects of rehabilitation training on muscle function and muscle aging-related outcomes will be evaluated. The results of this study are expected to contribute to the development of digital biomarkers and precision rehabilitation strategies for sarcopenia.

Longitudinal Body Composition Assessment in Breast Cancer Patients

This observational cohort study aims to track longitudinal changes in body composition, including skeletal muscle mass and fat distribution, in patients diagnosed with breast cancer. Following primary surgery and adjuvant therapy, participants will be monitored over a 2-year period. The primary objective is to evaluate the natural progression of skeletal muscle mass index (SMI) and metabolic changes in this population. By conducting serial measurements, this study seeks to characterize the longitudinal trends in muscle loss and body composition shifts post-treatment, providing data to better understand the physiological impact of the cancer recovery process.

Physical Activity and Exercise During Early Treatment Phases for Childhood Acute Lymphoblastic Leukaemia to Protect Against Muscle Loss and Improve Frailty Outcomes

This is a small trial testing out a new approach before doing a bigger study. Researchers are observing a group of children/adolescents (ages 5-17) with acute lymphoblastic leukemia (ALL) and testing a physical activity and exercise program on a group of them who after 5 weeks of treatment show signs of weakness or frailty. Kids who are NOT losing muscle aren't part of the exercise trial - they're just monitored over time to see how they do. The goal: To see if an exercise program helps kids who are getting weaker from acute lymphoblastic leukemia treatment build back/maintain their strength, compared to kids who don't do the extra intervention. The study will also look at if this way of measuring muscle weakness works well for kids with cancer.

Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors

This study evaluates the comparative effectiveness of a multi-modal facility-based rehabilitation program (therapist-led resistance exercise and relaxation training) versus a self-directed home-based resistance exercise program in post-treatment breast cancer survivors. Participants in both intervention groups will complete a 16-week program consisting of two exercise sessions per week.The multimodal, therapist-led approach is hypothesized to result in superior improvements in physical performance and quality of life outcomes compared to self-directed home exercise

Studying the Impairment of Stroke and Sarcopenia Patients Using Maximum Voluntary Contractions of the Leg Joints.

The goal of this study is to obtain the maximum voluntary torques of the lower-limb joints and to monitor oxygen level in the main lower-limb muscles. This will be done for three joints: i.e. the hip, knee and ankle joint and NIRS sensors will be placed on the biceps femoris, rectus femoris and gastrocnemius muscle. For the hip and knee, the maximum torque will be determined both in exertion direction and flexion direction. For the ankle, both plantarflexion and dorsiflexion will be considered. For each of these directions, the maximum joint torque will be defined for different specific joint angles and joint velocities (see procedure). For every joint and for the whole protocol for the torques measurement campaign, the different muscle of interest will be monitored with the NIRS, i.e. hip is associated with hamstring contraction, knee is associated with thigh contraction and ankle is associated with calf contraction. With these discrete points, an algorithm will be used to obtain a complete plot of the maximum torque in function of both joint angle and joint velocities. Comparing these plots between for example stroke and healthy individuals can help us understand what level of assistance stroke patients require. Comparison in oxygen level between healthy individuals and impairments population of stroke and sarcopenia patients can also help us investigate how oxygen is used depending on the population.

Muscle Loss and Fatigue as a Consequence of Radiotherapy

This study examines the extent of systemic muscle loss and the degree of fatigue experienced by breast cancer patients undergoing radiotherapy. This study seeks to identify whether muscle loss occurs outside the radiation fields and if muscle loss is correlated with the degree of fatigue.

Prehab and Creatine/Whey Supplementation in Frailty Among Patients With Cirrhosis

Frailty and muscle health are important for patients with chronic liver disease. This study looks at the use of a digital prehabilitation app (HEAL-ME) plus creatine and whey protein combination supplementation on maintaining muscle health in patients with liver disease. The investigators anticipate that this combination of supplementation and nutrition/exercise prehabilitation app will maintain muscle health in patients with liver disease.