Clinical Research Directory

TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status

The purpose of this study is to compare the effects of a standardized Traditional Chinese Medicine (TCM) formula versus beta-hydroxy-beta-methylbutyrate (HMB) on muscle strength and bone health in pre-frail older adults . Pre-frailty is a critical stage where functional decline may still be reversed through proper intervention. The study will enroll 90 participants aged 65 years or older who meet the criteria for pre-frailty. Participants will be randomly assigned to either the TCM group (receiving a standardized herbal powder formula) or the HMB group (receiving nutritional supplement tablets) for 24 weeks . The primary objective is to evaluate the change in handgrip strength from baseline to Week 12 . Researchers will also assess changes in skeletal muscle mass, bone mineral density, and overall physical performance . The goal is to determine if the TCM formula is an effective alternative or complementary intervention for managing geriatric frailty.

Sarcopenia in Chronic Kidney Disease (CKD) Patients

Sarcopenia, or loss of muscle and strength is common in patients with poor kidney function. Although a high protein diet is generally recommended for sarcopenia, patients with poor kidney function are advised to follow a low-protein diet. In this study, we will evaluate the practicality and potential benefits of two different amino acids (molecules that form proteins) in improving sarcopenia in patients with advanced kidney disease. The study aims to improve muscle mass and strength. All study procedures are free of cost and do not require significant time commitment. You will have time to ask questions and discuss the study with your family, primary care physician, and your kidney doctor to make the decision if this is right study for you to participate in.

Exercise Intervention for Breast Cancer Patients With Sarcopenia

Sarcopenia is a common yet underrecognized complication in breast cancer survivors during rehabilitation, characterized by loss of muscle mass, reduced muscle strength, and impaired physical function, which adversely affects quality of life and long-term outcomes. Exercise has been identified as a promising non-pharmacological intervention for sarcopenia; however, evidence-based exercise programs specifically tailored for breast cancer patients with sarcopenia remain limited. This study aims to develop and evaluate a 12-week exercise intervention program ("Exercise for Muscle Health") for breast cancer patients with sarcopenia during rehabilitation. A randomized controlled trial will be conducted to assess the effectiveness of the intervention. A total of 104 eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a 12-week structured exercise program combined with health education, while the control group will receive routine rehabilitation care with general physical activity recommendations. The primary outcomes include changes in appendicular skeletal muscle mass index (ASMI), handgrip strength, Short Physical Performance Battery (SPPB) score, and physical fitness (2-Minute Step Test and 30-second Chair-Stand Test). Secondary outcomes include sarcopenia-related knowledge, cancer self-efficacy, social support, anxiety, fatigue, and quality of life. Assessments will be conducted at baseline (T0), mid-intervention (week 6, T1), immediately post-intervention (week 12, T2), and 3 months post-intervention (T3). The hypothesis is that the 12-week "Exercise for Muscle Health" program will significantly improve muscle mass, muscle strength, and physical function compared to routine care, and will be feasible, acceptable, and safe for breast cancer patients with sarcopenia during rehabilitation.

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.

Group Exercise Program Supported By Audiovisual Media During Hemodialysis

People with chronic kidney disease (CKD) undergoing hemodialysis (HD) experience muscular complications, such as sarcopenia, which worsen their functional capacity and increase mortality. Exercise programs during HD are an effective strategy to combat sedentary behavior, and implementing them through innovative technologies could facilitate their adoption in clinics, benefiting more patients. Therefore, the study's objectives are to assess the feasibility and safety of a group exercise program supported by audiovisual media conducted during HD sessions. Additionally, it will analyze factors influencing adherence, identify potential causes for interruptions or failure to perform the prescribed exercise, and evaluate the risk and prevalence of sarcopenia, its association with low muscle strength, poor muscle quality, and physical inactivity.

Dietary Challenges in the Population of Nursing Homes' Residents

To obtain up-to-date data on nutritional status of older adults, a national dietary survey will be conducted in 2022/2023, providing data on the consumption of foods and enabling the assessment intakes of energy and specific nutrients. Participating subjects will be also screened for micronutrient status using blood biomarkers (focusing into vitamin D, folic acid, vitamin B12, and iron).

Sarcopenia and Training Outcomes in Post-cardiac Surgery Patients

The goal of this observational study is to assess the prevalence of sarcopenia and see whether the current care is sufficient to improve sarcopenia outcomes in patients after cardiac surgery. The main questions it aims to answer are: How prevalent is sarcopenia after cardiac surgery? Is the current standard of care sufficient to improve sarcopenia outcomes after cardiac surgery? Participants will: * Perform test to assess sarcopenia one day before leaving the hospital * Perform these tests again after 4 weeks, 16 weeks, and/or 1 year depending on their sarcopenia status at baseline and whether or not they will follow a cardiac rehabilitation program

The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women

Osteosarcopenia (OSP) is defined as the coexistence of sarcopenia and osteoporosis/osteopenia. There is an intense and complex interaction-both mechanical (the "mechanostat" hypothesis) and biochemical (involving factors such as estrogen, testosterone, GH, IGF-1, IL-6, and osteocalcin)-between osteoporosis and sarcopenia. The general consensus is that sarcopenia leads to a reduction in bone mineral density. OSP is associated with significant physical disability, which poses a major threat to the future loss of independence. The increased propensity for falls-a consequence of sarcopenia-compounds the risk of fractures associated with osteoporosis, further exacerbating adverse health outcomes. Kinesiophobia, or the "fear of movement," is an excessive and irrational dread of performing physical movements or activities, stemming from the fear of a painful injury or the possibility of re-injury; this often leads to restrictions in activities of daily living. In a clinical setting, kinesiophobia is a critical issue that must be addressed to effectively manage a patient's disability, as it directly influences rehabilitation strategies. While there is some limited literature exploring the individual associations of osteoporosis and sarcopenia with kinesiophobia, no research has yet examined the relationship between osteosarcopenia and kinesiophobia. Our study aims to determine the impact of osteosarcopenia on kinesiophobia and quality of life in postmenopausal women.

Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia

The TUN-CKDN study is a national, multicenter, prospective cohort study conducted in nephrology centers in Tunisia. It aims to describe how often malnutrition and sarcopenia (loss of muscle strength and muscle mass) occur in adults with chronic kidney disease (CKD) stages G3a to G5D, including patients not on dialysis and patients treated by hemodialysis or peritoneal dialysis, and whether these conditions are linked to future health outcomes. At inclusion, each participant will undergo a standardized nutritional and muscle assessment as part of routine care: medical history, physical activity questionnaire, clinical examination, body weight and height, body composition by bioelectrical impedance analysis (or calf circumference when impedance cannot be performed), a chair-stand test for muscle strength, a 4-meter walking speed test, routine blood tests, and a detailed dietary interview conducted by a trained dietitian. Malnutrition will be defined using the Global Leadership Initiative on Malnutrition (GLIM) criteria and sarcopenia using the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) criteria. The Malnutrition-Inflammation Score (MIS) will also be calculated. Participants available at 2 years will have the same nutritional and muscle assessment repeated. All participants will be followed at 2 and 5 years to record kidney outcomes (start of dialysis or kidney transplantation in patients not on dialysis at inclusion), major cardiovascular events, hospitalizations, and deaths. The study does not involve any treatment or change in usual medical care. About 4,000 participants are planned.

Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity

The study aims to explore whether a high level of AGEs (Advanced Glycation end products) derived from the diet may mediate diet-related muscle loss in Western-type diet, influencing the onset and progression of sarcopenia, predisposing to earlier and more severe metabolic consequences, including type 2 diabetes (T2D). The primary objective of the study is to investigate how the accumulation of AGEs is correlated with muscle loss in adult patients with obesity and type 2 diabetes or lipodystrophy in order to identify possible targets to mitigate the metabolic alterations caused by the Western diet (WD). Specifically, circulating AGEs levels on the skin will be evaluated and correlated with the stage of sarcopenia in a group of patients with obesity and a T2D diagnosis. Furthermore, the relationship between disease duration and AGE levels will be assessed. A secondary objective will be to analyze the clinical data obtained to identify metabolites and metabolic pathways responsible for the phenotype induced by the WD. The ultimate aim of the study is therefore to verify whether high levels of AGEs are correlated with an early and/or more pronounced onset of sarcopenia, concurrently with an increase in inflammation and oxidative stress.

Sarcopenia Risk in Obese T2DM Patients

This study aims to measure handgrip strength, walking speed, and the risk of muscle wasting in obese patients who have had diabetes for 5 years or longer, and to evaluate the relationship of these measures with factors that may influence them, such as the duration of diabetes, blood test results, body mass index, and the waist-to-height ratio.

Smart Tech-Based Nutrition and Exercise for Sarcopenia Risk.

Sarcopenia, characterized by muscle loss and weakness, is a major health issue among older adults and impacts mobility and quality of life. This study addresses the current lack of long-term, technology-assisted support for managing this condition at home. This randomized controlled trial (RCT) will evaluate a 12-week smart-technology-based program for 60 older adults at risk of sarcopenia. Intervention: Participants in the intervention group will receive a technology-assisted program delivered through a Line Bot system. The platform provides personalized exercise training videos, nutrition education, daily reminders, and a point-based logging system to support adherence and monitor engagement. The control group will receive standard clinic-based care. Purpose: The study aims to examine whether the smart technology intervention can improve muscle mass, physical performance, quality of life, and self-management ability among older adults at risk of sarcopenia. Expected Benefit: The digital intervention is anticipated to offer a more effective, accessible, and sustainable approach compared with standard care, providing practical support for preventing muscle decline in community-dwelling older adults

Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease

Huntington's disease (HD) is a rare neurodegenerative disorder in which accelerated loss of muscle mass, strength and autonomy (physical frailty and sarcopenia) contributes to functional decline. This randomized, double-blind, placebo-controlled, four-arm parallel trial will include adults with HD and physical frailty/sarcopenia. All participants will follow a 12-week individualized, home-based multicomponent exercise program (VIVIFRAIL-based, with weekly remote monitoring) and will be randomized 1:1:1:1 to placebo, creatine (CRE), beta-hydroxy-beta-methylbutyrate (HMB) or combined CRE+HMB. The study will test whether combined CRE+HMB produces synergistic improvements in functional capacity, neuromuscular performance, body composition, cognition and quality of life, and will use multi-omic profiling (circulating and extracellular-vesicle microRNAs, plasma proteomics and genetics) to identify mechanisms and predictive signatures of response. Durability of effects will be assessed 6 months after the end of the intervention.

Selenium, Sarcopenia, and Frailty in Hemodialysis

Chronic kidney disease (CKD) is a significant public health issue with an increasing prevalence worldwide. In patients undergoing hemodialysis (HD) in particular, various factors-such as chronic inflammation, oxidative stress, nutritional disorders, and micronutrient deficiencies-can negatively affect muscle health and physical function. Selenium, an essential trace element with potent antioxidant properties, has been shown to be present at low levels in these patients and may be associated with muscle strength. Sarcopenia and frailty are critical clinical conditions in HD patients that diminish quality of life and increase the risk of hospitalization and mortality. This study aims to evaluate the relationship between serum selenium levels, sarcopenia, and frailty in patients undergoing chronic hemodialysis, and to investigate whether selenium levels might serve as a potential biomarker for these clinical conditions.

Muscle Impact of Treating Osteoporosis

Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity). There is strong evidence of overlap between the pathophysiology of osteoporosis and sarcopenia (muscle-bone crosstalk). This research plan will further explore the relationship between bone and muscle, and provide new information about effect of osteoporosis medications on muscle health in older adults who are under treatment for osteoporosis.

PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty

Fibroblast Growth Factor 19 (FGF-19) is an intestinal hormone secreted in the post-prandial state, whose primary role is to inhibit bile acid synthesis in the liver. It is expressed by the FXR (Farnesoid X receptor) nuclear receptor in the enterocytes of the ileum, which is activated by specific bile acids metabolized in the gut microbiota. It was demonstrated that treatment with FGF-19 induces myofiber hypertrophy in vitro and increases muscle strength and mass in mice model of sarcopenia. Sarcopenia and the commonly associated physical frailty, are age-related syndromes associated with adverse events (such as falls and fractures, mobility disability) and increased mortality. Currently, there is no drug treatment that has been proven effective to counteract those syndromes and standard care consists in non-pharmacological interventions (exercise and nutrition) whose implementation remains complex due to several barriers. Moreover, the anabolic resistance underlying sarcopenia hampers the exercise-induced response on muscle mass and the level of evidence for this outcome remains poor-to-moderate. Thus, FGF-19 could be considered as a new regulator of skeletal muscle in elderly living with sarcopenia/frailty but there are, to date, only few data available in the literature. First and foremost, it is crucial to understand the relationship between postprandial FGF-19 and muscle which has not been characterized yet. Preliminary data suggest an inverse relationship between FGF-19 and physical function (OR= 0.33 \[0.15;0.7\] for the highest tertile of FGF-19) that persisted only in the cluster of frail individuals (OR= 0.19 \[0.05;0.65\]. Mechanistically, this suggests a positive feedback loop of the bile acids-gut-microbiota-FGF-19 in the presence of frailty/sarcopenia hence indicating that FGF-19 may be a novel biomarker of this condition.

Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome

The aim of this study is to evaluate the frequency of probable sarcopenia and sarcopenia in patients with primary Sjögren syndrome and to investigate the effects of sarcopenia on functional status, muscle strength, and quality of life. Adult patients diagnosed with primary Sjögren syndrome will be included in the study. Muscle strength, muscle mass, physical performance, and functional status will be assessed using various evaluation methods

Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.

This study evaluates the effects of a community-based multicomponent exercise program on physical function, frailty, and sarcopenia in older adults living in the municipality of Santoña (Cantabria, Spain). The exercise program is organized and delivered by the Santoña Town Council as part of its public health services for older residents and is not created for research purposes; it will continue regardless of the outcome of this study. Researchers are only evaluating participants who voluntarily agree to be assessed before and after each 36-week cycle of the program, over four consecutive academic years (2026-2030). The main question this study aims to answer is whether continued participation in this real-world, community-based multicomponent exercise program (based on the Vivifrail model) leads to meaningful improvements in physical function, muscle strength, and cardiorespiratory capacity, and helps reverse indicators of frailty and sarcopenia in independent, community-dwelling older adults. Participants will complete functional and physical tests, including balance, gait speed, chair-stand performance, handgrip strength, and a 6-minute walk test, at the start and end of each 36-week exercise cycle. No blood or biological samples will be collected.

Sarcopenia in Acute Ischemic Stroke

The objective of this observational study is to determine the prevalence of sarcopenia in patients aged 50 years and older with acute ischemic stroke, to characterize its trajectory during the acute phase using instrumental verification and functional-cognitive assessments, and to evaluate its impact on functional outcome at three months. The main research question is: Is the presence of sarcopenia at admission associated with less favorable stroke outcomes, including higher rates of complications and mortality? Participants receiving standard medical care for acute ischemic stroke will undergo extended functional assessment for sarcopenia, and a subset will additionally undergo cognitive evaluation.

The Effects of Technological Oral Health Management

The goal of interventional study is to for the elderly who have poor chewing and eating ability after installing removable dentures through the intervention of oral mastication training and texture and diet education, the effects on oral health, eating ability, nutrition, and physical function changes are confirmed in Elderly individuals residing in Chiayi County who are 65 years of age or older, capable of self-care, conscious, and able to communicate in Mandarin and Taiwanese. The main question it aims to answer is: •Are there significant benefits to oral health, eating ability, nutrition, and physical function through the intervention of oral mastication training and texture and diet education? Researchers will compare changes in oral health, eating ability, nutrition, and physical functioning results to see if oral mastication training is effective. Participants will: * Experimental group: oral mastication training and texture and diet education. * Control group: only texture and diet education. * Cases were tracked in month 1 and will be tracked again in month 6.

Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus

Hypoglycemia poses a particular danger for elderly patients with type 2 diabetes mellitus (T2DM). According to data, more than 30% of patients aged 60-69 years experience hypoglycemic episodes, and among persons over 85 years this figure exceeds 50%. The high risk is due to age-related changes: slowing of drug metabolism, decreased renal and hepatic function, weakening of counter-regulatory hormonal reactions, and impaired recognition of warning symptoms of severe hypoglycemia. The consequences of hypoglycemia in old age are especially severe, including increased risk of cardiovascular catastrophes, falls and fractures, and cognitive decline. This study aimed to identify predictors of hypoglycemia and assess its probability in elderly and senile women with T2DM for prevention in clinical practice.

RCT of Combination Effect of Vibration Treatment and HMB Supplementation on Myosteatosis and NMJ Degeneration

The investigators' pre-clinical study confirms the positive effects of combined treatment (VT + HMB) on reducing fat-to-lean tissue ratio, intramuscular fat infiltration and increasing muscle strength in sarcopenia animal model. The results showed that fat mass could be decreased by \~32%, while histology Oil Red O staining indicated a decrease of fat by almost 60%; in contrast, lean muscle mass increased by \~14%. On muscle strength, combined treatment increased twitch force, tetanic force and grip strength by \~30-66%. These in vivo results are very encouraging and the investigators should explore its potential in clinical translation. As VT and HMB supplement have been commercially available and their compliance rates are satisfactory, they can be translated to clinical application easily. The investigators' next step is to confirm its clinical efficacy, so that sarcopenia becomes a new indication of VT and HMB. The hypothesis is that combined treatment of VT and HMB can retard the progression of sarcopenia in human, in terms of muscle mass, muscle strength and performance.

Yijinjing Exercise for Musculoskeletal Health in Adults With Sarcopenia

Sarcopenia is a condition involving loss of muscle mass and strength that can make walking and other daily activities more difficult. This study will compare a modified seven-form Yijinjing exercise program with resistance training in 240 adults aged 50 years or older with sarcopenia at six hospitals in Beijing. Yijinjing is a traditional Chinese exercise that combines movements, breathing and focused attention. For the first 6 months, participants will be randomly assigned to Yijinjing or resistance training. Exercise is scheduled at least three times per week, with one supervised group session and two remotely supervised home sessions. Both groups will receive the same dietary counseling and health education. The main question is whether Yijinjing improves physical performance at 6 months by an amount that is not meaningfully worse than resistance training. Physical performance will be measured using the Short Physical Performance Battery, which includes balance, walking and repeated chair stands. After the 6-month assessment, participants in the resistance training group will switch to standard-duration Yijinjing. Eligible participants originally assigned to Yijinjing will be randomly assigned again to standard-duration or longer-duration Yijinjing for another 6 months. Participants who are not eligible for this second random assignment may continue standard-duration Yijinjing when clinically appropriate. Assessments at baseline, 6 months and 12 months will examine muscle mass and strength, physical function, quality of life and other health measures. Exercise-related adverse events will be monitored throughout the 12-month intervention.

Egg Albumin and Agave Fructans With Exercise in Hemodialysis

Patients receiving maintenance hemodialysis frequently develop loss of muscle mass, reduced physical function, and chronic inflammation. This randomized controlled trial will evaluate whether oral supplementation with egg albumin and agave fructans combined with a structured functional exercise program improves muscle mass, physical function, muscle strength, inflammatory status, phase angle, and quality of life compared with nutritional supplementation alone. A total of 66 adult participants receiving maintenance hemodialysis at Centenario Hospital Miguel Hidalgo will be randomly assigned to one of the two intervention groups and followed for 6 months.