Clinical Research Directory

Endurance Trial: Ketone and Carbohydrate Supplementation

This randomized, double-blind, crossover study investigates the effects of exogenous ketone supplementation on physical and cognitive performance in amateur endurance athletes during exhaustive exercise. Participants will complete three 3-hour cycling sessions under different nutritional conditions: carbohydrate alone (CHO), carbohydrate plus ketone (CHO-KET), and placebo (PLA). The study will assess cognitive function through validated computerized tests, physical performance via distance covered, and metabolic responses through blood biomarkers. Additionally, peripheral blood mononuclear cells (PBMCs) will be collected and cultured with LPS or not. Other PBMCs co-cultured with neuronal cells (SH-SY5Y) to investigate neuro-immune interactions. The primary hypothesis is that ketone supplementation will preserve cognitive function and enhance physical performance during prolonged exhaustive exercise compared to carbohydrate supplementation alone, potentially through anti-inflammatory mechanisms and alternative energy substrate provision.

Implementation of the 3-steps Assess-Advise-Refer Exercise (FitARise) Protocol as a Standard Practice in Cancer Care

This study proposes to evaluate the process and outcome of an implementation program designed to implement the American College of Sports Medicine (ACMS)-recommended exercise assessment, advice, and referral instruction as standard practices in routine cancer care.

Effects of Exercise Training Delivered Through Telerehabilitation on Text Neck Syndrome

To compare the effectiveness of telerehabilitation exercise program with that of supervised in-person physiotherapy in improving neck muscle endurance, pain intensity, and functional disability in university students with text neck syndrome. Methods: A randomized controlled trial was conducted with 31 university students aged 18-24 diagnosed with text neck syndrome. Participants were randomly assigned to either a telerehabilitation group or a supervised in-person exercise group. Both groups received an identical six-week exercise program, delivered three times per week, including stretching, range of motion, isometric, and postural correction exercises with progressive intensity. Primary outcomes included deep cervical flexor and extensor muscle endurance. Secondary outcomes were neck pain intensity and functional disability. Assessments were performed at baseline and post-intervention.

The Effect of an AIoT-Based Smart Exercise System in Older Adults

This clinical trial aims to evaluate the effectiveness of an artificial intelligence of things (AIoT)-based exercise system for seniors. Participants will undergo a 12-week AIoT-based cycle ergometer training program. Physical fitness and functional performance will be assessed at baseline and after completion of the intervention. Throughout the intervention, exercise-related data, including exercise duration, workload, heart rate, oxygen consumption, perceived exertion, and facial expressions, will be continuously and simultaneously collected for analysis.

Qigong and Multicomponent Exercise in Panic Disorder

Panic disorder is a psychiatric disease characterized by recurrent panic attacks that occur in expected or unexpected situations and create feelings of intense fear, restlessness and discomfort. Panic disorder often has a chronic course, its frequency and severity can be irregular, various physical, mental, and behavioral symptoms can develop, and the quality of life of individuals can decrease significantly. Evidence-based psychotherapy and pharmacotherapy are effective in reducing the symptoms of panic disorder and managing the disorder. However, both of these treatment methods have certain limitations, and approximately one-third of patients do not respond to therapy or the response is not sufficiently effective. Delaying treatment of the disease results in a poor prognosis and more established symptoms. Exercise can be viewed as a low-cost, supportive treatment for relieving symptoms with comparable efficacy to medication and other psychological interventions. Although exercise is recommended for patients with anxiety-panic disorder, there remains uncertainty about whether its effects are sustainable, the type and intensity of exercise required for effective treatment, and thus the effects of qigong and multicomponent exercise on multiple health outcomes in panic disorder. The aim of this study is to examine the effects of Qigong exercise training and multicomponent exercise training on anxiety-panic, balance, mobility, walking, functional strength, physical activity, sleep quality, fatigue, chronic musculoskeletal pain, quality of life and cognition.

A Digital Exercise Intervention in Patients With Spondyloarthritis

This protocol describes a 6-month randomised, controlled exercise trial in patients with axial spondyloarthritis (axSpA) with re-randomization after 3-months. The primary outcome of the trial (disease activity) will be evaluated at 3-months. The exercise programme on trial comprises high intensity interval training (HIIT), muscular strength exercise and aerobic physical activity sessions of specified duration, frequency, and intensity. It also includes brief knowledge videos to empower the patient. The intervention is remotely delivered by the SPARK application with personalised follow-up including monitoring to ensure exercise progression and adherence to exercise intensity. The SPARK application is built on a platform delivered by ABEL Technologies (trademark) and is customised for patients with axSpA.

Creatine and Resistance Training in Older Adults With Mild Cognitive Impairment

The goal of this 26-week trial is to learn if creatine supplementation and resistance training (i.e., weightlifting; exercise that increases muscle mass), alone and together, impact cognition, brain health, and physical function in older adults with mild cognitive impairment. Previous studies have shown that resistance training improves cognition and brain health in older adults. Creatine is naturally occurring in the human body and is known to decline with age. Studies have shown that creatine increases muscle mass and bone density in older adults when supplemented. Some research has suggested that creatine may also improve cognition and brain health. However, little is known about how creatine supplementation affects the aging brain and body alone and when combined with resistance training, especially in those with known cognitive impairment. In this study, participants will be randomly assigned to one of four groups: 1) creatine and resistance training, 2) placebo and resistance training, 3) creatine and active control (balance and tone classes), or 4) placebo and active control. Participants in the creatine groups will take creatine every day during the study. Participants in the placebo groups will take a look-alike substance that contains no drug every day during the study. Participants in the resistance training groups will attend three 60-minute classes per week that target each major muscle group and will increase in difficulty during the study. Participants in the active control group will attend three 60-minute classes per week that will consist of balance, stretching, and range of motion exercises. This group accounts for variables such as physical training received by traveling to the training centres, social interaction, and changes in lifestyle secondary to study participation. Researchers will collect information before and after the 26 weeks to see if creatine supplementation and/or resistance training have any effects on cognition, brain health, and/or physical function. The investigators suspect that both creatine supplementation and resistance training will improve cognition, brain health, and physical function alone. However, it is thought that the combination of creatine supplementation and resistance training will improve cognition, brain health, and physical function more.

Home-Based Exercise Programs for Fall Prevention in Parkinson Disease

Falls are common in patients with Parkinson disease and may lead to reduced mobility, fear of falling, loss of independence, and injury. Exercise-based rehabilitation programs may help improve balance, gait, and physical performance in this population. This randomized controlled trial aims to compare the effectiveness of two home-based exercise programs in patients with Parkinson disease: the Otago Exercise Program and a structured home exercise program. Participants will be randomly assigned to one of two groups. Both groups will receive exercise education and will perform their assigned home exercise program for 6 weeks. Participants will be evaluated at baseline, at week 3, and at the end of week 6. The study will assess fall-related outcomes, freezing of gait, functional mobility, gait parameters, postural control, and physical performance. The results may help determine which home-based exercise approach is more effective for reducing fall risk and improving functional outcomes in patients with Parkinson disease.

Bone and Body Composition Adaptations to Physical Training

The goal of this clinical trial is to evaluate how different exercise programs alter bone density, structure, and strength in adults. It will also collect data on hormones, factors released from skeletal muscle, and body composition. The main questions it aims to answer are: * Do exercise programs that are frequent with high-impact loading will cause greater improvements in bone health? * What changes in hormones, factors released from skeletal muscle, and body composition contribute to bone adaptations? Researchers will compare different exercise groups to see if the type of exercise influences bone adaptation compared to a recreationally active control group. Participants are asked to: * complete questionnaires, 5 blood draws across the study (3 at rest, 2 after strenuous exercise), dual energy x-ray absorptiometry (DXA) scans (to assess bone mineral density and body composition), high resolution tibial scans to assess bone structure and geometry, and physical performance testing. * attend up to 7 testing visits. * (for those randomized to the exercise training intervention) participate in exercise training sessions for 6 months.

AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury

This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance exercise adherence and health outcomes in mTBI patients. Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I evaluates feasibility and acceptability through Delphi methods with expert consensus and patient feedback; Phase II validates preliminary outcomes with 30 participants in a 2-arm randomized trial; and Phase III assesses the program's impact on exercise adherence, exercise motivation, mHealth app usability, functional capacity, sleep quality, depressive symptoms, concussion symptoms, and quality of life with 90 participants in a 3-arm randomized trial. In Phase III, quantitative and qualitative data will be collected in parallel, with qualitative data collected through semi-structured interviews to explore participants' experiences and perceptions of the intervention.

Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain

A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports centre. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.

The Impact of the Menstrual Cycle on Physical Exercise and Performance

The menstrual cycle implies a basic difference in the biology of women and men but the effect of the hormonal variation on training protocols and physical performance is still not fully understood. Despite no existing evidence, the advice to periodize exercise according to the menstrual cycle has been widely spread among elite athletes, coaches, and sports federations. The advice is based on underpowered studies with considerable methodological weaknesses regarding determination of cycle phase, inclusion of athletes and lack of adequate control groups. The purpose of this randomized, controlled study is to evaluate the effect of exercise periodization on aerobic fitness during different phases of the menstrual cycle. Further, the effect will be related to premenstrual symptoms, body composition and skeletal muscle morphology, sex hormone receptors, metabolic enzymes, and markers of muscle protein synthesis. This study will be well controlled and follow methodology recommendations for menstrual cycle research in sports and exercise. Female athletes of fertile age will be randomized to different training regimens during three menstrual cycles (12 weeks): Group A: Training three times a week throughout the menstrual cycle. Group B: Follicular phase-based training five times a week during the follicular phase and thereafter once a week during the luteal phase. Group C: Luteal phase-based training five times a week during the luteal phase and once a week in the follicular phase. The exercise will consist of high intensity intermittent spinning classes. Assessment of aerobic fitness and power will be performed at baseline, and again after three completed menstrual cycles. On the same day, body composition will be examined by DXA and blood samples will be collected for analysis of hormones and binding proteins. To confirm menstrual cycle phase, blood samples will be collected for hormone determination, and urinary stick will be used for detection of ovulation. Subjective ratings of menstrual cycle related symptoms will be performed every day. In a subgroup of women, muscle biopsies will be collected from m vastus lateralis at baseline and at the end of the study. This study will contribute to improved knowledge about exercise periodization in relation to the menstrual cycle. Well-grounded data is crucial to give evidence-based recommendations to female athletes when planning their training protocol to optimize training results and performance.

A Feasibility Randomised Controlled Trial of an Online Exercise Programme for Adults With Cerebral Palsy

Adults with cerebral palsy (CP) often face challenges in accessing exercise programmes that are appropriate for their needs. Barriers such as limited mobility, a lack of tailored options, and restricted access to physiotherapy services can make participation difficult. Exercise is important for improving physical health, mental well-being, and overall quality of life. However, many adults with CP do not have regular opportunities to take part in structured physical activity. This study aims to investigate whether an online exercise programme can serve as an effective and accessible alternative. The main aim of the study is to assess the feasibility of delivering an online exercise programme for adults with CP. Key areas of focus will include demand, implementation, practicality, adaptability, acceptability, and potential benefits to physical, mental, and social well-being. A total of 60 adults with CP will be recruited and randomly assigned to one of two groups (30 participants per group). One group will complete an 8-week online exercise and education programme. The second group will receive the same educational materials during the study and will be provided with information about the home exercise programme after the 8-week intervention period. Data will be collected on attendance, completion rates, engagement with exercises, and any reported adverse events. Health-related surveys will be completed before and after the programme to assess any changes. In addition, a selected group of participants from the intervention group will take part in interviews to provide feedback on their experiences. Findings from this study may support the development of accessible, effective, and person-centred online exercise programmes for adults with CP. Results may help improve future programme design and contribute to better care and support for adults with CP in Ireland.

Whole-Body Vibration and Balneotherapy in Chronic Low Back Pain

This randomized controlled clinical trial aims to investigate the effects of whole-body vibration (WBV) exercises combined with balneotherapy on pain, physical function, sleep quality, and daily activity levels in individuals with chronic low back pain. A total of 60 volunteers aged 18 to 65 who have been diagnosed with chronic low back pain by a physical medicine and rehabilitation specialist and who meet the eligibility criteria will be included. Participants will be randomly assigned to two groups. Both groups will receive balneotherapy five days a week for three weeks. After balneotherapy, the first group will perform standard stretching, strengthening, and aerobic exercises designed for low back pain. The second group will receive the same exercise program in combination with WBV exercises using a vibration platform. WBV sessions will include static and dynamic exercises with specific frequency and amplitude settings. All participants will be evaluated at baseline and after three weeks using validated measures, including pain intensity (Visual Analog Scale), spinal mobility (Modified Schober Test), balance and reach (Functional Reach Test), physical performance (Sit-to-Stand and Timed Up and Go Tests), disability (Oswestry Disability Index, Roland-Morris Questionnaire), and sleep quality (Pittsburgh Sleep Quality Index). The study seeks to determine whether combining WBV with balneotherapy can provide additional benefits over standard exercise alone in managing chronic low back pain.

Comprehensive Dementia Management : From Translational Medicine to Innovative Care

The purpose of this stage is to conduct analysis and discussion through expert meetings (consultation) based on the current data of the elderly in each dementia base and Rizhao Center, as well as the weekly courses and activities of the service site (base, Rizhao), and make recommendations.

Effect of Acute Exercise on Sensory and Hedonic Responses to a Fixed Meal in Adolescents With Obesity

While long considered independently, energy expenditure and energy intake have been shown to interact. Fot the last 20 years, the litterature has been describing tyhe effects of an acute bout of exercise on subsequent energy intake and appetitive responses, indicating a potenital anorexigenic effect of intensive exercise in adolescents with obesity. These studies suggest a decrease in hunger, redcued satiety and modified food reward responses. These results remain however obtained in studies using post exercise ad libitum test meals and this nature of the meal might ahve impact these responses. The present work tends to assess the effect of acute exercise on subsequent appetite and food reward responses to a fixed meal, in adolescents with obesity.

High-Intensity Functional Training (HIFT) vs Moderate-Intensity Continuous Training (MICT) in College Students

The purpose of this study is to compare two types of exercise programs in college students: high-intensity functional training and moderate-intensity continuous training. The study evaluates whether these exercise programs improve body composition, physical fitness, and blood vessel health compared with a group that does not participate in exercise training. In addition, the study examines whether changes in body composition and physical fitness are associated with changes in blood vessel health.

Effects of Progressive Neuromuscular Stabilization Exercises Versus Aerobic Exercises on Body Composition and Postural Balance in Children With Obesity

Introduction: Childhood obesity can impair postural control, balance, and motor skills, thereby limiting participation in physical activity. Aerobic exercise is widely used to improve cardiovascular fitness and support weight management in children with obesity. In recent years, however, Progressive Neuromuscular Stabilization (PNS) exercises, which aim to retrain the neuromuscular system, have been suggested to have beneficial effects on core stability, balance, and postural control. Technology-assisted exercise interventions may increase children's participation and enhance motivation throughout the rehabilitation process. This study aims to compare the effectiveness of technology-assisted PNS exercises with conventional aerobic exercise in children with obesity. Methods: This study will be conducted among children attending the Department of Pediatrics, Istanbul University-Cerrahpaşa who meet the eligibility criteria. Children aged 12-18 years with obesity will be recruited. Participants will be randomly allocated into three groups: the Aerobic Exercise (AE) group, the Progressive Neuromuscular Stabilization (PNS) group, and the Control group. Participants in the exercise groups will receive supervised exercise sessions twice weekly for 12 weeks in a clinical setting and will be instructed to perform home-based exercises on the remaining days. Home exercise programs will be delivered through the BeCure® mobile application, where exercise videos will be uploaded, and participants will be asked to perform progressively advancing exercises on a weekly basis. The control group will receive a single session of exercise counseling. Outcome assessments will be performed before and after the intervention. Sample Size: The sample size was calculated using G\*Power version 3.1. Based on moderate effect sizes reported in the literature (Lengkana et al., 2019), the effect size was set at f = 0.30, with a significance level of α = 0.05 and statistical power of 1 - β = 0.95. Power analysis for a repeated-measures design with three groups and two measurement time points (baseline and post-intervention) indicated a minimum total sample size of 48 participants. To account for potential dropouts, a total of 54 participants will be recruited. Participants will be assigned to the study groups using block randomization stratified by age and sex. Primary Outcome Measure: Balance and postural control will be assessed using the Biodex Balance System. Secondary Outcome Measures: Body composition will be evaluated using Body Mass Index (BMI), triceps and subscapular skinfold thickness, waist circumference, and Bioelectrical Impedance Analysis (BIA) to determine body fat percentage. Core muscle endurance will be assessed using the Prone Plank Test and the Side Plank Test. Functional performance will be evaluated using the 6-Minute Walk Test (6MWT), the 30-Second Sit-to-Stand Test (30-s STS), and the 20-Meter Shuttle Run Test. Physical activity level will be assessed using the Physical Activity Questionnaire for Children (PAQ-C). Self-perception and body image will be evaluated using the Self-Perception Profile for Children (SPPC). Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), while fatigue will be evaluated using the PedsQL Multidimensional Fatigue Scale. Posture will be assessed using the New York Posture Rating Scale. Study Plan: Each exercise session will last approximately 40 minutes, consisting of a 5-minute warm-up, 30 minutes of the main exercise program, and a 5-minute cool-down.

Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy

The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.

Comparative Effects of Kinesthetic Motor Imagery and Dual-Task Training on Balance and Cognitive Function in Young Adults: Randomized Controlled Trial

The goal of this clinical trial is to investigate the effects of kinesthetic motor imagery training and dual-task training on cognitive and motor functions in healthy young people. The main question\[s\] it aims to answer are: * Kinesthetic motor imagery training and dual-task training do not affect cognitive and motor functions in healthy young people. * Kinesthetic motor imagery training and dual-task training affect cognitive and motor functions in healthy youth. * In healthy young people, kinesthetic motor imagery training is more effective on cognitive functions than dual-task training. * In healthy young people, dual task training is more effective on motor functions than kinesthetic motor imagery training. Participants will be divided into 3 groups, taking into account the inclusion and exclusion criteria. Participants in each group will be asked to fill out the sociodemographic form before starting the training. Then, initial assessments were the Motion Image Questionnaire-3 to measure motor imagery ability, and the Box and Block Test for mental stopwatch; Stroop Test to measure cognitive functions; In order to evaluate the dual-task performance, the measurement of the dual-task effect and the Berg Balance scale, which evaluates balance as a motor function, and the Y test, which is frequently used in healthy individuals, will be applied. In the balance exercises group, the participants will do the determined balance exercises 3 days a week for 6 weeks, accompanied by a physiotherapist. In the double-task training group, the participants will perform the cognitive tasks in addition to the determined balance exercises, 3 days a week for 6 weeks, accompanied by a physiotherapist. In kinesthetic motor imagery group, the participants will do the physically determined balance exercises in the first session. Participants will participate in imagery exercises, 3 sessions a week for 6 weeks. Visualization studies will be performed in a quiet environment with the eyes closed, accompanied by a physiotherapist, and whether the participants perform a real motor imagery will be examined by evaluating their autonomic functions. At the end of 6 weeks, initial evaluations will be repeated in all groups. The investigators will compare dual-task training group, kinesthetic motor imagery training group and balance exercises group to see if changes in cognitive and motor function.

Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder

The purpose of this study is to compare the effects of a physiotherapy program on pain levels, shoulder range of motion, functional status, pain catastrophizing, perceived change, sleep quality, and quality of life in postmenopausal women diagnosed with frozen shoulder, with and without Hormone Replacement Therapy (HRT). The findings are expected to contribute to personalized treatment planning for postmenopausal women with frozen shoulder and help fill the gap in current literature.

Response to Exercise and Nitric Oxide in PAD

RESIST PAD is a randomized trial of 200 PAD patients to establish: 1) whether a 12-week exercise intervention significantly increases Δ nitrite at 12-week follow-up, compared to control; 2) whether exercise "responders" have greater Δ nitrite increases compared to "non-responders"; 3) among non-responders, whether supplementing exercise with nitrate-rich beetroot juice between weeks 13-24 increases Δ nitrite and improves 6-minute walk at 24-week follow-up.

LLM-Generated Coaching Prompts

This pilot study aims to evaluate whether personalized coaching prompts generated by a large language model (LLM) can effectively increase physical activity levels among participants. The study will involve 50 participants who will receive daily text messages, either personalized by the LLM or generic, over a 14-day period. Participants will share their HealthKit data for analysis. The findings will inform the development of future versions of the My Heart Counts application, enhancing user engagement and health outcomes.

Visual Stimulus-Based Cognitive-Motor Agility Exercise in Older Adults

This randomized controlled trial examined the effects of adding a brief visual stimulus-based cognitive-motor agility exercise component to a multicomponent exercise program in community-dwelling older adults. Participants were randomized to either an experimental group or an active control group. Both groups participated in supervised multicomponent exercise sessions twice weekly for 8 weeks. Each session lasted 45 minutes. During the final 10 minutes of each session, the experimental group performed the visual stimulus-based cognitive-motor agility exercises, whereas the active control group performed time-matched low-intensity activities. The primary outcome was global cognitive performance assessed using the Montreal Cognitive Assessment. Secondary outcomes included hand and foot visual-motor response time, visual working memory, and functional performance.