Clinical Research Directory

Effects of a Multidisciplinary Intervention on Muscle Strength, Posture, and Balance in Older Adults After an Earthquake

This randomized controlled trial evaluated the effects of a 12-week multidisciplinary intervention on muscle strength, postural alignment, and balance in older adults living in temporary container settlements following the February 2023 earthquakes in Kahramanmaraş, Türkiye. A total of 60 adults aged 65 years and older were allocated to an intervention group (n=30) or a control group (n=30). The intervention group participated in an individualized health management program that included exercises targeting muscle strength, balance, mobility, and posture, together with nutritional counseling, psychosocial support, and health education. The control group received no active intervention and underwent assessments at baseline and after 12 weeks. Muscle strength was assessed using digital and manual dynamometers. Postural alignment was evaluated using PostureScreen, while postural sway and balance were assessed using Gyko and functional performance tests, including the Timed Up and Go Test and Short Physical Performance Battery. The study aimed to determine whether a multidisciplinary intervention could improve physical function, postural alignment, and balance in older adults living in post-disaster temporary housing.

Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age

The goal of this clinical trial is to learn whether taking a daily supplement of β-hydroxy-β-methylbutyrate (HMB) while following a structured exercise program improves body composition, muscle strength and physical performance in older women. The main question it aims to answer is: does HMB (3 g per day) combined with the Vivifrail multicomponent exercise program improve handgrip strength more than the same exercise program combined with maltodextrin without HMB? Researchers will also compare body composition and physical performance between groups. Participants will take the assigned supplement every day for 12 weeks, attend three supervised Vivifrail exercise sessions per week at the Casa Club de la Tercera Edad (DIF Tulancingo, Hidalgo, Mexico), and complete evaluations at baseline, week 6 and week 12.

Community-Based Multicomponent Exercise and Recreational Programme for Older Adults

This quasi-experimental, non-randomized controlled evaluation examined whether participation in ELDERPLAY, a community-based programme combining Vivifrail-based multicomponent exercise with adapted traditional games, was associated with changes in physical performance and frailty-related function in community-dwelling adults aged 65 years and older, and estimated the cost of delivering the programme. Participants were allocated to the intervention group or to a concurrent control group through voluntary enrolment and geographic matching, without randomization. The intervention consisted of 20 supervised group sessions, two per week over ten weeks. Physical performance was assessed with the Short Physical Performance Battery and the Timed Up and Go test at baseline, at week 5 and at week 10. Secondary exploratory outcomes included actigraphy-derived daily step count, heart rate and sleep parameters, recorded over seven consecutive days at a single intermediate assessment point, and sleep quality assessed with the Pittsburgh Sleep Quality Index. Programme delivery costs were estimated from the perspective of the programme provider using an activity-based costing approach. Because allocation was not randomized and the groups differed at baseline, the findings are associative and do not support causal inference.

Oral Function Intervention in Community-Dwelling Older Adults

Oral frailty is a potentially reversible condition associated with physical frailty and functional decline in older adults. Interventions targeting oral function may therefore improve broader physical health. This study aim to evaluate oral and physical functional changes after a 6-month integrated intervention and compare these changes over 12 months.

Magnetic Mitohormesis (MM) Treatment in Stroke Rehabilitation.

Although sarcopenia is commonly seen in stroke patients with a prevalence rate of 42%, relevant research studies are more in geriatric population rather than in stroke patients. Beside conventional functional physiotherapy, improving blood circulation, improving cellular oxygenation and reducing inflammation by MM therapy is supposed to improve muscle atrophy after stroke, thus enhancing the functional recovery. The investigators are not investigating the direct effect of MM therapy on muscle mass in the current study, but are looking at the function outcomes and changes in quality of life of patients after MM therapy, which is more relevant to the clinical practice in stroke recovery. Based on literature review and previous studies, stroke patients might benefit from MM therapy by enhancing the outcomes in functional mobility and measures of quality of life, so the purpose of this study is to investigate if MM treatment could boost the functional recovery and muscle strength on top of the effects from the conventional physiotherapy. The findings of this study might improve the medical knowledge on how MM therapy could affect clinical function outcome in post-stroke rehabilitation and provide alternative method to enhance motor recovery.

Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)

TRU-OMNIBODY is a prospective observational study designed to develop and independently validate a research-only whole-body digital twin. The digital twin will combine measurements from multiple body systems to create a participant-specific representation of physiologic state, resilience, and recovery. The study plans to enroll approximately 450 adults between 18 and 80 years of age. Participants will include generally healthy adults and adults with stable cardiometabolic, respiratory, or mobility-related conditions. Study measurements may include wearable-sensor data, heart rate and rhythm, blood pressure, oxygen saturation, autonomic responses, body composition, mobility, muscle function, sleep, activity, cognitive performance, point-of-care imaging, laboratory measurements, and optional biospecimens. Participants will complete a standardized resilience assessment consisting of rest, active standing, a six-minute walk, a cognitive dual task, and monitored recovery. Selected measurements will also be collected during home monitoring and follow-up visits for up to 12 months. The primary objective is to determine how accurately a locked digital-twin model predicts Whole-Body Recovery Burden, a research measure derived from the timing and magnitude of recovery across several physiologic systems. Model development and testing will be separated so that the final evaluation is performed in an independent validation cohort. This study does not assign participants to a medical treatment. Digital-twin outputs will not be used to diagnose disease, recommend treatment, or replace evaluation by a qualified health care professional.

Functional Constipation and Fall-Related Outcomes in Older Adults

This retrospective cross-sectional observational study aims to examine the relationship between Rome IV functional constipation and fall history, functional capacity, and physical activity in older adults. The study will use routinely recorded clinical data from older adults aged 65 to 80 years who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center between April 2024 and April 2026. No new intervention, treatment, exercise program, drug, or device will be applied as part of this study. Functional constipation will be evaluated using bowel habit data recorded in patient files and classified according to the Rome IV criteria. Fall history within the last 12 months will be obtained from routine clinical records. Functional capacity will be assessed using recorded results from the 6-Minute Walk Test and the Five Times Sit-to-Stand Test. Physical activity level will be evaluated using available International Physical Activity Questionnaire data. The study will include data from 208 eligible older adults. The main purpose is to determine whether older adults with Rome IV functional constipation differ from those without functional constipation in terms of fall history, walking capacity, lower extremity functional performance, and physical activity level. The findings may help clarify whether functional constipation in older adults is associated not only with bowel habits but also with broader geriatric and rehabilitation-related outcomes.

Effects of Whole Body Vibration in Different Devices on Bone and Muscle Mass in Postmenopausal Women

Postmenopausal women suffer from a series of negative health factors, such as decreased bone and muscle mass and physical performance, increasing the risk of falls and decreasing quality of life. Therefore, intervention strategies aimed at mitigating these factors are essential. A technique that has been studied and can reverse these factors is whole-body vibration (WBV), however studies present contradictory results and the main confounding factor appears to be related to the type of vibration (synchronous or side-alternating). Therefore, the primary objective of this project is to verify the effects of 12 months of whole-body vibration on different devices on bone mineral density measurements in postmenopausal women. As a secondary objective, the effects on muscle mass, physical performance, quality of life and falls will be verified. 127 postmenopausal women will participate in the study and will be randomized to: triplanar vibration (synchronous); side-alternating vibration; or false vibration. The interventions will last 12 months and will occur three times a week on non-consecutive days. The following assessments will be carried out at baseline, 6-months and 12-months: bone mineral density and muscle mass by DXA equipment, muscle thickness by ultrasound, peak torque of the knee extensor and flexor muscles by an isokinetic dynamometer, hand grip, balance static postural and vertical jump on a force platform, dynamic balance using the Timed Up and Go test, SPPB battery, fear (FES-I) and incidence of falls and quality of life (SF-36).

The Efficacy of Aerobic Exercise Training on ANS and Endothelial Function in Compensated Cirrhosis

The goal of this randomized controlled trial is to investigate whether a 16-week structured aerobic exercise program combined with nutritional consultation can improve autonomic and endothelial function in patients with compensated cirrhosis. Study Design: This assessor-blinded, parallel-group randomized controlled trial will be conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand. Fifty adults with compensated (Child-Pugh class A) cirrhosis will be recruited during routine hepatology clinic visits. Eligible participants are aged 45-75 years, have a sedentary lifestyle (\<150 minutes of moderate or \<75 minutes of vigorous physical activity per week), and have abstained from alcohol for at least six months. Exclusion criteria include active or recently treated hepatocellular carcinoma (within three months), severe portal hypertension complications (untreated large varices, prior variceal bleeding, or severe gastropathy), transjugular intrahepatic portosystemic shunt (TIPS), unstable cardiac disease, orthopedic limitations, morbid obesity (BMI \>35 kg/m²), or current use of alpha- or beta-blockers that affect autonomic function. Intervention: Participants will be randomly assigned to either the intervention or control group. Both groups will receive nutritional consultation and individualized dietary guidance at baseline, week 8, and week 16. Nutritional goals are set at 35 kcal/kg/day and 1.2 g/kg/day of protein intake. If targets are unmet, the dietitian will provide individualized recommendations to support adequate intake. The intervention group will participate in a 16-week aerobic exercise program consisting of brisk walking at moderate intensity (50-70% of maximal heart rate), totaling 150 minutes per week. The program includes two phases: * Phase 1 (Weeks 1-4): Combined hospital-based (1 session per week) and home-based exercise under physical therapist supervision, with gradual intensity titration. * Phase 2 (Weeks 5-16): Fully home-based exercise following prescribed intensity and frequency, with weekly follow-up via telephone or messaging to monitor adherence, safety, and exercise log completion. The control group will maintain their usual physical activity levels while receiving the same schedule of nutritional consultations and weekly follow-up for monitoring compliance and adverse events. Outcomes: Primary outcomes include changes in autonomic and endothelial function after 16 weeks. * Autonomic function will be assessed using the Ewing autonomic battery test (HR response to standing, deep breathing, and Valsalva maneuver; BP response to posture and sustained handgrip) and heart rate variability (HRV) indices (SDNN, RMSSD, LF/HF ratio). * Endothelial function will be evaluated using flow-mediated dilation (FMD) of the brachial artery, analyzed via Cardiovascular Suite™ software to assess nitric oxide-dependent vasodilation. Secondary outcomes include: 1. Splanchnic hemodynamics: Changes in celiac and superior mesenteric artery (SMA) blood flow measured via mesenteric Doppler ultrasound (Vivid IQ, GE Healthcare). Time-averaged mean velocity (TAMV), vessel diameter, and blood flow will be recorded at baseline and post-intervention. 2. Sarcopenia-related measures: Muscle mass (DEXA, BIA), muscle strength (handgrip dynamometry), and physical performance (6-minute walk test). 3. Laboratory outcomes: Serum ammonia, liver function tests, fasting glucose, albumin, renal function, and coagulation profile. 4. Correlative analyses: Associations between (a) muscle mass and serum ammonia, and (b) muscle mass and autonomic parameters (e.g., HRV indices).

Strengthening Children's Coordination and Balance in Everyday Life

The World Health Organization recommends that children and teenagers aged 5 to 17 should be physically active for at least 60 minutes every day. This should include activities that make them breathe harder, as well as exercises that strengthen muscles and bones. National guidelines in Austria and Germany also highlight the importance of basic movement skills such as endurance, strength, coordination, and balance. Regular physical activity is important for children's physical and mental health. It can help prevent problems such as obesity, diabetes, and heart disease. It can also support learning, concentration, and school performance. However, many children do not move enough. In Austria and Germany, only a small number of children and teenagers meet the recommended activity levels. Because of this, many programs have been created to encourage children to be more active, for example through active breaks, park activities, or sports clubs. These programs often include simple movement games, warm-up exercises, and strengthening exercises such as squats. Balance and coordination exercises are used less often. Also, many programs mainly count how many children take part, but they do not always measure how the programs improve children's movement skills. This study therefore looks at whether targeted balance and coordination training improves the motor skills of children aged 6 to 11 in school sports. It will compare this training with strength training. Over four weeks, children will take part in one of the two training programs. Their motor skills, such as coordination, strength, flexibility, and endurance, will be tested before and after the program. The study will also look at how the children's general physical activity level influences their motor development.

DEVELOPMENT AND PSYCHOMETRIC EVALUATION OF THE NEUROCOGNITIVE UPPER EXTREMITY TESTS: A RELIABILITY AND VALIDITY STUDY

The goal of this observational study is to develop an upper extremity neurocognitive performance test battery, determine its reliability and validity, and investigate the effect of neurocognitive load on test performance in athletes and healthy volunteers aged 18-40. The main questions it aims to answer are: Are the developed upper extremity neurocognitive tests reliable and valid tool for assessment? Does the addition of neurocognitive load significantly affect upper extremity physical performance scores? Are the neurocognitive performance test results related to shoulder rotator cuff muscle strength, rate of force development, and shoulder function? Researchers will compare the neurocognitive performance of athletes to healthy non-athlete individuals to see if the test battery can effectively differentiate between these two groups (discriminative validity). Participants will: Complete demographic forms and questionnaires regarding activity level and shoulder function. Undergo shoulder range of motion and isometric strength/rate of force development assessments. Perform a battery of 4 neurocognitive tests integrated with a light-based reaction system. Perform the same functional tests without neurocognitive load to serve as a baseline for comparison. (Athletes only) Attend additional sessions to evaluate the feasibility of the tests and to assess test-retest reliability with a one-week interval.

Outdoor Horseback Riding and Its Effects on Muscle Strength, Balance, Sleep, and Movement

This study aims to investigate the effects of regular outdoor horseback riding on lower extremity muscle strength, core stabilization, balance, functional movement capacity, sleep quality, and overall well-being in healthy adults. Participants with at least 6 months of routine outdoor horseback riding will be compared to non-riders to evaluate differences in physical performance and functional capacity. The study will provide evidence on the potential health benefits of horseback riding.

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.

Prehabilitation for Colorectal Cancer Patients With Low Functional Capacity and Malnutrition

Despite multi-modal prehabilitation (nutrition, exercise, and psychosocial interventions), 60% of older elective colorectal cancer surgery patients with poor physical function were unable to reach a minimum preoperative 400m six-minute walking distance (6MWD), a prognostic cut-point. Compared to the patients that attained \>400m 6MWD preoperatively, twice as many of \<400m patients were malnourished. Malnutrition has long been associated with worse functioning (e.g., physical, immune). The investigators hypothesize that for nutritionally deficient patients, the etiology for their poor physical function is malnutrition. Correction of malnutrition alone might thus be sufficient to achieve a 400m 6MWD before surgery and improve patient outcomes.

Interactive Exergaming With Otago Exercise Program on Mobility in Community-Dwelling Older Adults

This clinical trial aims to evaluate the effectiveness of interactive exergaming combined with Otago Exercise Program on mobility among community-dwelling older adults aged 65 and above. The main research questions are: Does this combined exercise intervention improve elderly mobility? Does this program enhance muscle strength and psychological well-being? Researchers will compare two groups: one group will do the combined exercise program for 12 weeks, while the other group will continue their usual activities. Participants will: * Have their health checked three times: at the start, after 12 weeks, and 3 months later * If in the exercise group, attend exercise sessions twice a week for 12 weeks * Complete tests about their physical abilities and how they feel emotionally Who can take part: * Adults age 65 or older * People who need more than 12 seconds to stand up and sit down 5 times * People who can stand for at least 30 seconds with support People cannot take part if they have serious vision problems, recent leg injuries, major illnesses, significant memory problems, or mental health conditions.

Action Observation Training for Functional Performance in Children with Cerebral Palsy

This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation.

Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms

Muscle mass loss is a common adverse effect of cancer. Muscle mass loss occurs with or without reduction in body weight. Cancer cachexia (CC) is the involuntary loss of body weight of \>5% within 6 months and it occurs in 50-80% of patients with metastatic cancer. It is estimated that CC is a direct cause of up to 30% of all cancer-related deaths. No treatment currently is available to prevent CC, likely because the chemical reactions that causes of this devastating phenomenon in unknown. No treatment currently is available to prevent muscle mass loss in patients with cancer but is urgently needed as the reduced muscle mass and function is associated with impaired physical function, reduced tolerance to anticancer therapy, poor quality of life (QoL), and reduced survival. There is evidence of an interdependence between informal caregiver (e.g. spouse) and patient QoL. Thus, identifying caregiver distress and needs can potentially benefit QoL for patients with cancer cachexia. Despite the enormous impact on disease outcomes, it is not known why the loss of muscle mass and function occurs and very few studies have investigated the underlying molecular causes in humans. In particular, there is a severe lack of studies that have obtained human skeletal muscle and adipose tissue sample material. Such reference sample materials will be invaluable to obtaining in-depth molecular information about the underlying molecular causes of the involuntary but common muscle mass and fat mass loss in cancer. At a whole body level, cancer cachexia is associated with reduced sensitivity to the hormone insulin, high levels of lipids in the blood, and inflammation. Within the skeletal muscle, the muscle mass loss is associated with elevated protein breakdown and reduced protein build-up while emerging, yet, limited data also suggest malfunction of the power plants of the cells called mitochondrions. The role of malnutrition and how it contributes to weight loss is understood only to the extent of the observed loss of appetite and the reduced food intake because of pain, nausea, candidiasis of the mouth, and breathlessness. Evidence is increasing that the environment of the intestinal system could be implicated in cancer cachexia, yet, the possible effect of cancer and the cancer treatment on the intestinal environment is not understood. Thus, large and as yet poorly understood details of this syndrome precede a later weight loss. Exercise training could help restore muscle function and how the chemical reactions works in cancer. In healthy people, and patients with diabetes, cardiovascular disease, and obesity exercise potently improves health. Exercise has been thought to slow down the unwanted effects of cancer cachexia by changing the reactions mentioned above. Thus, there is a tremendous gap in our knowledge of how and if exercise can restore the cells power plants function, muscle mass, strength, and hormone sensitivity in human cachexic skeletal muscle. Tackling that problem and examining potential mechanisms, will enable us to harness the benefits of exercise for optimizing the treatment of patients with cancer. The data will provide novel clinical knowledge on cachexia in cancer and therefore addressing a fundamental societal problem. Three specific aims will be addressed in corresponding work packages (WPs): * investigate the involvement of hormone sensitivity of insulin and measure the chemical reactions between the cells in patients with lung cancer (NSCLC) and describe the physical performance and measure amount of e.g. muscles and adipose tissue across the 1st type of cancer treatment and understand how that is related to the disease and how patients and informal caregiver feel (WP1). * find changes in the chemical reactions in skeletal muscle, adipose tissue (AT), and blood samples in these patients, to understand how to predict how the disease will develop (WP2). * measure changes of skeletal muscle tissue in response to exercise and see if it might reverse the hormone insensitivity and improve muscle signaling and function (WP3). The investigators believe that: * the majority of patients with advanced lung cancer, at the time of diagnosis already are in a cachectic state, where they lose appetite, and have hormonal changes, and an overall altered chemical actions between the cells affecting both muscle mass and AT. The investigators propose that all this can predict how the disease will progress, and how patient- and informal caregiver fell and how they rate their quality of life. * lung cancer and the treatment thereof is linked with changes in the blood, the muscle tissues, and the adipose tissues, especially in patients experiencing cachexia, that could be targeted to develop new treatment. * exercise can restore the muscles and improve insulin sensitivity and improve the function of the cells power plants in patients with lung cancer-associated muscle problems.