Clinical Research Directory

Effects of Cyclical Blood Flow Restriction Exercise on Muscle Hypertrophy and Capillaries in Older Adults

The purpose of this study was to learn if low-load resistance exercise combined with cyclical blood flow restriction (BFR) could improve small blood vessel structure and muscle size in older adults. Skeletal muscle thinning and the loss of tiny blood vessels (capillaries) commonly happen as people age. While lifting heavy weights can help stop this, heavy loads are often not suitable for older adults with joint pain or other health conditions. Low-load exercise with BFR involves wearing inflatable cuffs on the upper arms that temporarily slow down blood flow, which can trigger positive changes in muscles and blood vessels without needing heavy weights. Researchers compared three groups of older adults: * One group performed low-load upper-body exercises while wearing cyclical BFR cuffs. * A second group performed the exact same exercises at the same low load but without wearing cuffs. * A third group maintained their normal daily activities without participating in any structured exercise program. Participants in the exercise groups trained 3 days a week for 8 weeks. Researchers used video capillaroscopy (a specialized camera at the fingernail base) to examine changes in tiny blood vessels and ultrasound imaging to measure arm muscle thickness before and after the 8-week period.

The Study, Conducted With 54 Individuals Over the Age of 65, Aimed to Reveal the Advantages and Disadvantages of a Combined Exercise Program Compared to Otago Exercise Alone.

Falls are a leading cause of morbidity and mortality in older adults. Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury. Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls. One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand. The program includes strength and balance exercises progressed with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in older adults. Proprioceptive exercises aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration. Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited. The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals. It is expected that the findings will contribute to more effective and goal-oriented planning of exercise programs in the geriatric population.

Multicomponent Exercise and Frailty in Nursing Home Residents

Frailty is common among older adults living in nursing homes and increases the risk of falls, disability, and loss of independence. However, there is limited evidence on practical and feasible exercise programs adapted to this population. This study evaluated the effects of a multicomponent exercise program combining strength and balance training in residents aged 65 years and older. Participants were assigned to either an intervention group, which performed supervised exercise sessions twice a week for 8 weeks, or a control group, which continued their usual activities. The main outcome was frailty, measured using the Short Physical Performance Battery. Other outcomes included balance, functional independence, sarcopenia, fear of falling, and number of falls. This study was retrospectively registered.

Effects of Aquatic Exercise in Older Adults With Sarcopenia:A Randomized Trial

Sarcopenia is a geriatric syndrome characterized by age-related loss of skeletal muscle mass, strength, and physical performance, leading to increased risk of falls, functional decline, and reduced quality of life. Exercise interventions, particularly resistance training, are effective in managing sarcopenia; however, land-based exercises may be challenging for older adults due to balance impairments, joint problems, and fear of falling. Pool-based exercise programs may offer a safe and feasible alternative, as water buoyancy reduces joint loading while providing resistance to support muscle strengthening. Despite these potential benefits, evidence regarding the effects of aquatic exercise in individuals with sarcopenia remains limited, especially in Türkiye. This study aims to evaluate the effects of a 6-week supervised pool-based exercise program on muscle strength, muscle morphology, physical performance, mood, and quality of life in individuals aged 65 years and older with sarcopenia. Sarcopenia will be identified using the Sonographic Thigh Adjustment Ratio (STAR), based on ultrasound measurements of anterior thigh muscle thickness. In addition, appendicular skeletal muscle mass will be assessed using bioelectrical impedance analysis (ASM/height²). Outcome measures will include ultrasound-based muscle thickness, STAR, muscle strength, functional performance tests, depressive symptoms, and health-related quality of life. Assessments will be performed at baseline, immediately after the intervention, and at 1-month follow-up.

Exergaming-based Sitting Tai Chi for Sarcopenia and/or Frailty

This randomized controlled trial will evaluate the effects of an exergaming-based sitting Tai Chi program on muscle strength, physical function, cognition, and psychosocial outcomes in older adults living in residential care facilities who are at risk of sarcopenia and/or prefrailty. Eligible participants aged 60 years or older will be identified using simple screening criteria for sarcopenia and prefrailty and will not meet full diagnostic criteria for sarcopenia or frailty. A total of 152 participants will be randomly assigned to either an individually supervised exergaming-based sitting Tai Chi intervention or a group-based general health education control, each delivered twice weekly for 12 weeks. The primary outcome is dominant-hand grip strength, a core indicator of sarcopenia-related muscle weakness. Key secondary outcomes include sitting balance and functional reach assessed by the Modified Functional Reach Test, with additional secondary measures of muscle mass, lower-extremity function, activities of daily living, reaction time and health-related quality of life. Outcomes will be assessed at baseline, mid-intervention, post-intervention, and 3-month follow-up. The findings will provide preliminary evidence on whether chair-based exergaming Tai Chi can be integrated into routine residential care to support healthy aging and functional independence.

A Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia

The goal of this clinical trial is to learn if intervention can treat sarcopenia in the elderly. Researchers will compare IN-207907 120 mg, 240 mg, 360 mg and placebo to see if SPPB score improves.

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.

Prevalence of Sarcopenia-Promoting Medicines in Patients With Sarcopenia and Falls

Sarcopenia, characterised by the loss of muscle mass and function, is a common condition among the elderly and is often associated with increased risk of falls. Certain medications, such as glucocorticoids, statins, and some antipsychotics, may exacerbate sarcopenia, leading to a higher incidence of falls. This study aims to explore the prevalence of such medicines in patients diagnosed with sarcopenia who have experienced falls. Understanding the impact of these medications on sarcopenia and fall risk can inform clinical guidelines and improve patient outcomes.

Frailty in the Elderly Oncological and Oncohematological Patient.

The Italian population is progressively aging, and cancer incidence increases with age. Older patients are at higher risk of frailty, a condition associated with adverse outcomes such as disability, falls, hospitalization, and mortality. Key indicators of frailty include reduced balance, impaired physical activity, cognitive decline, and particularly sarcopenia, defined as the progressive loss of skeletal muscle mass and strength. After age 60, muscle mass decreases by 1.4-2.5% annually, while muscle strength declines by 15% between ages 60-70 and by up to 30% per decade thereafter. Sarcopenia increases the risk of falls, fractures, hospitalization, and non-cancer-related death. In cancer patients, its prevalence ranges from 11% to 74% and is associated with poorer survival outcomes in both early and advanced disease stages.In clinical oncology practice, several tools are available to assess frailty, identify vulnerable patients, and personalize care, treatment, and supportive interventions.

Exercise Impact in Elderly With Multimorbidity: HbA1c and Blood Pressure

The main objective of the study is to compare the effect of two different types of physical exercise modalities on glycated hemoglobin and blood pressure in elderly individuals with multimorbidity. The main characteristic of the proposal is that it is experimental, with two intervention groups with physical exercise that will be randomized in the order of participation of the groups and forwarded to the researchers regarding the evaluations and training periods. In addition, the study will be controlled, as it has a control group that will not perform any intervention with physical exercises during the study period. To allocate the participants in each exercise group and for the control group, the researchers will use the 1:1 method, the user will receive an automatic generator through the random.org website. The main questions raised by the studies will be: Is land-based training more effective than aquatic training for this population in improving the primary outcomes? Is there a difference between training at these intensities and not doing any physical exercise in this population with these primary outcomes? Participants in the 2 intervention groups will: Train 3x per week for 10 weeks at intensities that will progress over the weeks.

Blood Flow Restriction Training in Acute Geriatric Rehabilitation

Background: Older adults have a reduced ability to build and maintain muscle mass due to age-related changes in the muscular system. The resulting sarcopenia can lead to a number of health problems and limitations, such as an increased risk of falling and reduced mobility, which can affect quality of life and increase the risk of disease. To increase muscle mass and strength, high-intensity resistance training with loads of 70 to 85% of the repetition maximum (1RM) is recommended. However, this type of training poses a major challenge in the rehabilitation sector, as there is also an increased risk of injury due to physical limitations in old age. According to current research, low-intensity occlusion training could therefore represent a safe and effective training alternative. The aim of this study is therefore to examine the feasibility and effects of blood flow restriction training (BFR) on general health in older adults in a rehabilitative setting.

A Study of PLH-2301 in Subjects With Sarcopenia

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Eligible subjects aged 65 years and older will be randomized to receive placebo or one of three dose levels of PLH-2301 once daily for 12 weeks. The primary objective is to assess the effect of PLH-2301 on physical function compared with placebo.

The Effect of Volunteer-Engaged Lifestyle Optimisation Via ICOPE on Sarcopenia in Older Adults (VELO-S)

Sarcopenia prevention and management are highly prioritised goals in the Healthy Ageing agenda. The study aims to: 1) evaluate the effects of the digital-enhanced, volunteer-engaged collaborative care pathway to improve sarcopenia, reduce fall risk, and increase health-related quality of life (HRQL) among community-dwelling older adults with risk of, or diagnosed with, sarcopenia; 2) evaluate whether the volunteers who received health coach capacity training and supported the intervention experienced health benefits across time; 3) explore the engagement experiences and perceived effects of elderly participants with sarcopenia during the program; 4) evaluate the intervention implementation process and effects from the perspectives of social care workers.

Effects of Resistance Training on Sarcopenia in Older Patients With Chronic Heart Failure

The goal of study is to evaluate the effects of an eight-week machine-based resistance training program on managing sarcopenia in older outpatients with chronic heart failure (HF) at Military Hospital 175.

Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia

With the agarose concentrating group of Peiyuan Guben Tongluo Ointment set as the parallel control and an external control established simultaneously, this study aimed to evaluate the increases from baseline in DXA-measured limb muscle mass after 12 weeks of medication in elderly sarcopenia patients treated with the Ejiao concentrating group of Peiyuan Guben Tongluo Ointment.

Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older adults, and if changes in muscle mass are linked to changes in functional status over the same time period.

Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty

Double-blind randomized placebo-controlled clinical trial with two parallel arms. The main objective is to evaluate the efficacy and safety of creatine supplementation in older adults who have been operated on for total knee arthroplasty and undergoing a usual rehabilitation program. The intervention will consist of daily creatine monohydrate supplementation for 12 weeks. The intervention will start after surgery with a loading dose of 20g/day for 1 week and then continue with a maintenance dose of 5g/day for 11 weeks. Main outcome mesures included muscle mass, muscle strenght, sarcopenia, frailty, functional capacity and physical performance and will be assessed at baseline, 3 and 6 months follow-up.

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.

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

Acute Sarcopenia in Hospitalized Older Adults

Acute sarcopenia is a rapid decline in muscle mass and function occurring within 28 days of a major stressor, such as hospitalization, infection, or surgery. It is frequent but often underdiagnosed in older adult. Current standard of care lacks systematic strategies for its early detection and risk stratification. This study therefore proposes to combine established clinical and instrumental assessments (handgrip dynamometry, bioelectrical impedance analysis, ultrasound of the anterior thigh) to better characterize the risk factors, and outcomes of acute sarcopenia in hospitalized patients aged 65 years or older. The study hypothesis is that the use of a systematic objective clinical assessments will improve early detection and risk stratification of this condition and the detection of acute sarcopenia related outcomes. This is a prospective observational cohort study that will be conducted in the Emergency Department and Medical Wards of the San Raffaele Hospital. Studies objectives will include: * Determination of the incidence of acute sarcopenia * Identification of clinical and demographic risk factors for acute sarcopenia and relevant clinical outcomes associated with this condition

Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia

Sarcopenic dysphagia is defined as swallowing difficulty among the elderly due to the loss of whole body skeletal and swallowing muscle mass and function. However, the pathophysiology and dynamics of swallowing in sarcopenic dysphagia have been poorly investigated. Therefore, the present study aims to investigate the characteristics of sarcopenic dysphagia using the Videofluoroscopic study (VFSS) focusing on each phase of dysphagia, and surface Electromyography (surface EMG) to assess suprahyoid muscle activity. In sarcopenic dysphagia, impairments will occur in both the oral and pharyngeal phases, particularly affecting bolus formation, premature bolus spillage and laryngeal elevation during swallowing due to the loss of swallowing muscle mass and function. These changes will be considered to have led to an change of duration and amplitude of suprahyoid muscle activity measured via surface EMG.

Muscle Strength Asymmetry In Sarkopenic And Non-sarcopenic Older Adults

The purpose of this observational study is to examine whether differences in muscle strength between the dominant and non-dominant sides of the body are associated with sarcopenia in older adults. The study will include adults aged 65 years and older with and without sarcopenia. Muscle strength will be measured on both sides of the body using handgrip strength as well as strength measurements of the biceps (upper arm muscle) and quadriceps (thigh muscle). The difference in strength between the dominant and non-dominant sides will be calculated and compared between participants with sarcopenia and those without sarcopenia. The main question it aims to answers are: * Do older adults with sarcopenia have larger differences in muscle strength between the two sides of the body compared with those without sarcopenia? * Can differences in arm and leg muscle strength help identify older adults who may be at higher risk of sarcopenia?

Evaluation of the JUICE HA® as an Anti-sarcopenia

This study plans to recruit 60 participants aged 65 years and older who have been diagnosed with sarcopenia by a physician. Participants will be randomly assigned into JUICE HA® supplement and placebo group. All of the participants will be asked to take 15 mL/day of JUICE HA® supplement or placebo group for 12 weeks. The aim of this trial is to evaluate the potential of JUICE HA® to enhance physiological status (muscle mass and functional fitness) and to improve the quality of life in patients with sarcopenia.

Impact of Pre-operative Sarcopenia on Functional Recovery After Hip Arthroplasty in Older Adults

This single-centre, exploratory study at Montpellier University Hospital will investigate whether having low muscle mass and strength before hip-replacement surgery, a condition called sarcopenia, impact the return to everyday independence in people aged 75 years or older. About 20 volunteers, scheduled for surgery because of a recent femoral-neck fracture or severe arthritis that no longer responds to usual care, will give consent, answer brief health questionnaires, attempt simple walking and chair-rise tests if possible, and provide a small blood sample. While they are already under anaesthesia for their planned operation, the surgical team will take a tiny muscle sample through the same incision, so no extra cuts are needed. During the hospital stay or shortly after discharge, each participant will have a painless MRI scan of the thigh muscles and a very-low-dose bone scan (DXA) to measure muscle and bone health. The research team will then telephone participants at 3 and 6 months to ask about daily activities, walking ability, and any complications. The study lasts about six months for each person and does not alter their usual medical or rehabilitation care. Potential benefits include close follow-up, personalised feedback on muscle and bone results, and helping doctors learn whether pre-surgery muscle weakness predicts slower recovery-information that could guide future, more personalised exercise and nutrition programs. Extra study procedures carry only minimal risks: a routine blood draw, scans with none (MRI) or very little (DXA) radiation, and a muscle biopsy taken during surgery. Taking part is entirely voluntary, and participants may withdraw at any time without affecting their current or future care. The whole project will run for 18 months.