Clinical Research Directory

Longitudinal Geriatric Vulnerability, Chemotherapy Toxicity, and Functional Outcomes in Older Adults With Gastrointestinal Cancer

Older adults with gastrointestinal cancers may be more likely to experience side effects from chemotherapy and difficulties with everyday activities. These problems are not always explained by age alone. Changes in nutrition, physical strength, general health, and independence may also affect how well a person tolerates cancer treatment. The purpose of the VITAL-GI study is to better understand how health-related vulnerability in older adults is associated with chemotherapy side effects and changes in daily functioning over time. This is an observational study involving adults aged 65 years or older with gastrointestinal cancer that has not spread to distant parts of the body. Participants receive chemotherapy as part of their usual medical care, either before or after surgery, according to their treatment plan. The study does not assign chemotherapy treatments or change routine care. Researchers use questionnaires and clinical information to assess general health, nutrition, physical abilities, independence, and the risk of chemotherapy side effects. Assessments are performed when chemotherapy begins and approximately 3 and 6 months later. The study examines whether initial health assessments can help identify people who are more likely to experience serious chemotherapy side effects. It also examines how health, daily activities, symptoms, and quality of life change during treatment. The findings may help researchers better understand the supportive care needs of older adults receiving chemotherapy for gastrointestinal cancer.

The Effect of Adding Elastic Resistance Training in Routine Physical Exercise on Walking Speed of Elderly People With Sarcopenia in Griya Wreda Jambangan, Surabaya

The goal of this randomized clinical trial is to learn whether adding elastic resistance training (ERT) to routine physical exercise can improve walking speed in older adults aged 60 years or older with sarcopenia living at Griya Wreda Jambangan, Surabaya. Sarcopenia is identified according to the Asian Working Group for Sarcopenia (AWGS) 2019 criteria. The main questions it aims to answer are: * Does adding elastic resistance training to routine physical exercise improve walking speed after 8 weeks? * Is the change in walking speed greater in participants who receive elastic resistance training plus routine physical exercise than in those who receive routine physical exercise alone? Researchers will compare routine physical exercise plus elastic resistance training with routine physical exercise alone to determine whether the addition of elastic resistance training results in greater improvement in walking speed. The study uses a randomized pre- and post-intervention controlled design. Participants will: * Be randomly assigned to either the intervention group or the control group. * Continue the routine physical exercise program provided at Griya Wreda Jambangan. * If assigned to the intervention group, perform elastic resistance training for the upper and lower extremities twice per week for 8 weeks, in addition to routine physical exercise. * Have their walking speed measured before and after the 8-week intervention using a walking test over the middle 6 meters of a 10-meter walkway. * Undergo clinical screening and monitoring to ensure that exercise participation is safe.

Functional Decline and Quality of Life After Gastrointestinal Cancer Surgery in Older Adults

This prospective cohort study will evaluate functional decline, health-related quality of life, and long-term oncological outcomes in adults aged 65 years and older undergoing curative-intent resective surgery for gastrointestinal cancer at Hospital Universitario Mayor-Méderi in Bogotá, Colombia. The primary objectives are to identify prognostic factors associated with functional decline and clinically meaningful deterioration in health-related quality of life at 12 months after surgery. Functional decline will be assessed using the Katz Index of Independence in Activities of Daily Living, and quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Long-term oncological outcomes will include overall survival, time to recurrence, and disease-free survival, with estimates reported at 1, 3, and 5 years after surgery. Participants will undergo standardized preoperative assessment of demographic, oncological, functional, frailty, nutritional, cognitive, psychological, and sarcopenia-related factors. Multivariable prognostic models will be developed to evaluate their association with the primary outcomes.

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.

Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy

Aproximately a third of persons older than 70 years lose physical function and ability to take care of themselves during a stay at a hospital. This is associated to an increased risk of readmission and mortality. Earlier research has shown that insufficient nutrition and physical activity during hospital stay, leading to a loss in muscle mass and strength, plays an important role in this fall in functionality. This study aims to examine if a structured and supervised resistance and mobility exercise intervention, can prevent this fall in functional ability during hospital stay among older patients. The Impact of nutritional status will be investigated by registrering caloric, protein and hydtrational intake during the study period.

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.

Tai Chi Exercise to Improve Quality of Life and Depression in Elderly With Sarcopenia

This study aims to evaluate the effects of Tai Chi exercise on quality of life and depressive symptoms in elderly with sarcopenia. Sarcopenia is characterized by a progressive decline in skeletal muscle mass and muscle strength, which may contribute to impaired physical function, reduced quality of life, and an increased risk of adverse health outcomes among older adults. Specifically, this study investigates the effects of an eight-week Tai Chi exercise program on health-related quality of life, assessed using the Sarcopenia Quality of Life (SarQoL) questionnaire, and depressive symptoms, assessed using the Geriatric Depression Scale-15 (GDS-15), in elderly individuals diagnosed with sarcopenia. The primary research question of this study is whether an eight-week Tai Chi exercise program can improve quality of life and reduce depressive symptoms in elderly individuals with sarcopenia. Furthermore, this study aims to determine whether Tai Chi exercise results in greater improvements in SarQoL scores and GDS-15 scores compared with a control group participating in standard elderly exercise.

RANK-ligand Inhibition to Combat Sarcopenia With Underlying Osteoporosis

The objective of this study was to conduct a randomized, double-blind, double-dummy active controlled trial to determine the efficacy of denosumab in treating sarcopenia with underlying osteoporosis.

Tai Chi Exercise to Improve Physical Capabilities in Elderly With Sarcopenia

This study aims to evaluate the effects of Tai Chi exercise on the physical performance of elderly individuals diagnosed with sarcopenia. Sarcopenia is characterized by a progressive loss of muscle mass and strength, which often leads to decreased physical function, mobility issues, and a higher risk of falls in older adults. Specifically, the research investigates the impact of an eight-week Tai Chi program on four key functional areas: handgrip strength measured by a dynamometer, balance evaluated through the 5-times Sit-to-Stand (5xSTS) test, mobility measured by the Timed Up and Go (TUG) test, and daily physical activity levels assessed via the Physical Activity Scale for the Elderly (PASE) questionnaire. The primary question this study seeks to answer is how Tai Chi exercise influences the physical performance of elderly patients with sarcopenia. Furthermore, it aims to determine whether practicing Tai Chi yields significant improvements in their handgrip strength, balance, mobility, and overall activity levels when compared to a control group participating in standard elderly gymnastics.

RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients

The objective of this study is to conduct a pragmatic, randomized, double-blind, active-controlled trial to assess the efficacy of receptor activator of nuclear factor-kB ligand (RANKL) inhibition in the treatment of sarcopenia in hip fractures.

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.

C-Protein in Fatigue and Aging

This study is investigating changes to the proteins in skeletal muscle that contribute to reduced muscle size and muscle function that occurs with aging.

Feasibility of Egg White Pudding Supplementation for Individuals in Personal Care Home Centres Needing Dietary Supplementation

This trial is an open-label randomized controlled parallel arm feasibility trial. 54 residents in care homes receiving nutrition supplementation (minimum 40% of each sex, ≥ 50 years of age). Participants will receive the egg white pudding (experimental) or a standard currently provided dietary supplement (control) on a daily basis and will be advised to follow any dietary recommendations they receive from their care team. Participants will be recruited at personal care homes throughout Winnipeg. Study visits will take place with a study coordinator at baseline and at 8 weeks (endpoint). Product acceptability will be assessed through dietary logs. This study has been reviewed and approved by The Committee for Harmonized Health Impact, Privacy, and Ethics Review (CHIPER).

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.

Frailty and Muscle Strength Tests in Older Adults Undergoing Major Surgery

The goal of this observational study is to learn if simple tests for frailty and muscle strength can help predict which older adults (age 65 and older) are at higher risk for problems after major abdominal surgery. The main questions it aims to answer are: * Do measures of frailty and muscle strength, taken before surgery, predict complications after surgery? * Can these tests be easily done during a routine pre-surgical visit? Participants will: * Complete brief tests measuring muscle strength, breathing strength, physical function, nutrition status, body composition, and memory during a regular pre-surgical clinic appointment. * Allow researchers to review their medical records 30 and 90 days after surgery to identify any complications or health problems.

Lactate Kinetics After Multimodal Exercise and Adjunctive Virtual Reality Exercise in Hospitalized Geriatric Patients

The goal of this clinical trial is to determine whether adding virtual reality exercise to conventional multimodal exercise affects exercise-related lactate kinetics, functional status, frailty, sarcopenia risk, perceived exertion, and health-related quality of life in adults aged 60 years or older who are hospitalized in an acute geriatric ward. The main questions it aims to answer are: 1. are there any difference in post exercise lactate at day 1 and 7 between the two groups? 2. does the lactate concentration reduces after low intensity resistance exercise in subject with high resting lactate? 3. Does virtual reality-assisted multimodal exercise improve functional independence, frailty status, sarcopenia risk, perceived exertion, and health-related quality of life from baseline to Day 7? Researchers will compare participants receiving conventional multimodal exercise plus virtual reality exercise with participants receiving conventional multimodal exercise alone to evaluate the additional effects of the virtual reality intervention. Participants will: * Undergo functional and medical assessments before starting the exercise program. * Receive an individualized conventional multimodal exercise program during hospitalization. * If assigned to the intervention group, perform additional virtual reality exercise using the VRAGMENT program. * Have capillary blood lactate concentrations measured immediately before and after standardized low-intensity resistance exercise on Day 1 and Day 7. * Complete the following assessments at baseline and on Day 7: * Barthel Index to assess functional independence. * Frailty Index-40 (FI-40) to assess frailty. * SARC-F to assess the risk of sarcopenia. * Borg Rating of Perceived Exertion (RPE) Scale to assess perceived exercise intensity. * EQ-5D-5L to assess health-related quality of life. * Have vital signs, exercise tolerance, and adverse events monitored throughout the intervention.

Feasibility of Pre-Conditioning FRT in Sarcopenia

This study aims to assess whether a short, structured exercise programme is suitable and acceptable for older adults with early-stage muscle weakness (known as probable sarcopenia). Sarcopenia is a common condition associated with ageing that leads to reduced muscle strength, mobility, and independence, increasing the risk of falls, hospitalisation, and reduced quality of life. Exercise, particularly resistance training, is recommended as the first-line treatment for sarcopenia. However, many programmes require participants to begin at relatively high levels of intensity, which may be challenging for individuals with low baseline strength or confidence. A short "pre-conditioning" phase of exercise may help prepare individuals physically and improve their ability to safely engage in more structured training in the future. This study will investigate an 8-week functional resistance training (FRT) programme designed to improve movement ability, strength, and confidence using exercises that mimic everyday activities such as standing, stepping, and lifting. Participants will be randomly assigned to complete the same programme either in a supervised and clinic-based setting or independently and home-based setting following instruction and guidance. The main aim of the study is to determine whether this type of programme is feasible and acceptable, including whether participants are willing to take part, attend sessions, and complete the programme safely. The study will also explore whether the programme may lead to improvements in physical function, strength, and quality of life.

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.

A Study of AMC6156 in People With Sarcopenia

This clinical trial aims to find out whether AMC6156 can improve physical function and is safe in older adults with sarcopenia. Participants will take AMC6156 or a placebo daily for 12 weeks, and their movement, strength, and safety will be regularly monitored through tests and checkups.

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.

Evaluation of the Effect of a Seaweed Flour- and Leucine-Enriched Food on Metabolic and Inflammatory Status in Older Adults With Probable Sarcopenia or Sarcopenia

Sarcopenia and probable sarcopenia are associated with loss of muscle strength, functional impairment, frailty, and an increased risk of adverse outcomes in older adults. In short-term interventions, structural or functional changes may be modest, whereas certain serum biomarkers of metabolic-nutritional response may be more sensitive. In this protocol version, serum transthyretin (TTR) has been selected as the primary outcome, without assuming that it represents, by itself, a direct measure of muscle mass or overall clinical efficacy.

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.