Clinical Research Directory

Effect of Aerobic Exercise Training on Cardiorespiratory Function in Patients With Traumatic Brain Injury

Background: \- Many people who have traumatic brain injury (TBI) have low levels of physical fitness. Low physical fitness causes severe fatigue that reduces the ability to perform routine daily activities, and may also cause increased depression, anxiety, or sadness. Aerobic exercise, such as treadmill walking or running, improves physical fitness in most people and may also decrease fatigue and improve mood. However, more information is needed to determine if exercise improves these conditions in people who have TBI. Objectives: \- To examine the effect of an aerobic treadmill walking exercise program on physical fitness, fatigue, and mood in people with TBI. Eligibility: \- Individuals between 21 and 45 years of age who had a nonpenetrating traumatic brain injury at least 6 months before participating; able to understand oral and written English language, give informed consent and sign a consent form; are physically inactive (including activities related to both job and recreation); and are able to stand and walk on a treadmill safely without help. Design: * This study requires 4 testing visits and 36 exercise visits over 14 weeks. * The first and third testing visits will last about 4 hours and the second and final testing visits will take about 2 hours. * Testing visits will consist of a medical history and physical examination, completion of questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test. * Participants will have treadmill exercise training 3 days per week for 12 weeks. Each session includes a check-in, warm-up, treadmill walking at the training heart rate, and cool-down. Thirty-two of the sessions will last for about 1 hour, and four of the sessions will include questionnaires to fill out and will last about one-and-a-half hours. * After completing the exercise training program, participants will have a final testing visit to complete the questionnaires (about fatigue, daily physical activity, sleep quality, mood, and overall quality of life), tests of thinking and a treadmill exercise test.

Step Count and Treatment Response in Neoadjuvant Breast Cancer

This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.

Exercise-Induced Lactate and Cognitive Function (ExLBC)

A single bout of exercise can rapidly improve cognitive functions including memory, attention, and executive functions, which help us navigate through everyday life. However, we do not fully understand the mechanism behind this process. A promising candidate mechanism is lactate, which was previously considered merely a waste product of our muscles during exercise. It is now recognized as an important molecule that is used by the brain as an energy source. Studies have shown that increases in lactate during exercise are positively related to improved cognitive function after completion of exercise. Another potential mechanism involves the increase in neurotrophins such as brain-derived neurotrophic factor (BDNF) following exercise. The increase in lactate and BDNF during exercise may be connected to cause these cognitive improvements. However, because lactate increases with higher exercise intensities, we currently do not know how lactate specifically impacts brain health. To address this, muscle and blood lactate concentrations can be experimentally manipulated during exercise using sodium bicarbonate (NaHCO3) supplementation and will allow us to explore how lactate specifically affects brain function. The purpose of this project is to investigate the effect of exercise-induced lactate on BDNF and cognition following oral NaHCO3 supplementation in young adults. We hypothesize that BDNF levels will be higher, and cognition will be improved in executive function, visuospatial memory, and working memory in the NaHCO3 condition due to higher plasma lactate during exercise compared to placebo.

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of the development of diabetes and poor cardiometabolic health. Obese and Black individuals have \~30% lower levels of NP and are at a greater risk of developing cardiovascular (CV) events as compared to lean and White counterparts. Some people have common genetic variations that cause them to have \~20% lower NP levels. Similar to other low NP populations, these individuals with low NP genotype (i.e., carrying a common genetic variation called rs5068) are at a greater risk of developing cardiometabolic diseases. By understanding the NP response following the exercise challenge and the glucose challenge in individuals with genetically lower NP levels will help us understand how to improve cardiometabolic health in them.

Study of Daily Step Count and Treatment Response in Rectal Cancer (STEP-R)

This study aims to examine the impact of daily physical activity, specifically step count, on treatment outcomes and side effects in patients with locally advanced rectal cancer receiving total neoadjuvant therapy (chemotherapy and radiotherapy before surgery). Using Huawei Watch Fit 2 smartwatches, we will track participants' daily step counts, heart rate, and sleep quality. The primary hypothesis is that higher step counts and physical activity levels correlate with higher rates of complete pathological response at surgery. A secondary hypothesis is that increased physical activity may be associated with fewer or less severe side effects during treatment. Participants will wear a smartwatch and complete the EORTC QLQ-C30 Quality of Life Questionnaire and the Pittsburgh Sleep Quality Index at the beginning and end of treatment. Data from the smartwatch, including step count, heart rate changes, and sleep duration, will be reviewed weekly during routine visits. Approximately 200 patients with rectal cancer will participate, and each will be followed from the start of therapy until surgery (around 4-6 months). Total data collection is expected to take 12-15 months. This study could improve cancer care by identifying links between physical activity and treatment outcomes, supporting future exercise guidelines for oncology patients.

Diurnal Strength Variation

Healthy individuals will be tested at different times of day to determine whether exercise at a non-expected time results in poorer performance.

TRX Training Intensity in Male Adolescent Basketball Players

This randomized interventional study aims to compare the effects of low-, moderate-, and high-intensity TRX suspension training on physical performance in male adolescent basketball players. Forty-two athletes aged 15 to 17 years are assigned to one of three TRX training intensity groups and complete an 8-week supervised training program in addition to their regular basketball practice. Outcomes are assessed before and after the intervention and include agility, dual-task agility, balance, upper-extremity muscular endurance, and rating of perceived exertion (RPE). The study seeks to determine whether different TRX training intensities produce distinct adaptations in these performance outcomes and to provide evidence for optimizing suspension-training prescription in youth basketball players.

Aerobic Exercise for Remyelination in Multiple Sclerosis

This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).

Effects of Fun-Core (Child-Friendly Core Stabilization) Exercises on Balance and Functional Mobility in Children With Spastic Cerebral Palsy

A total of 54 children, aged between 6 and 12 years, diagnosed with hemiplegic cerebral palsy and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2025 and March 1, 2026, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. Children and their parents will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and their informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Patient assessment and follow-up forms will be completed at pre- and post-treatment follow-ups. Patients who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention or control groups by a computer program. In addition to a brochure showing the number of sets and repetitions to be given to the patients as a standard home exercise program, the Fun-Core video exercise program, designed as a child-friendly core stabilization exercise program to be performed 3 times a week, will be given to the intervention group (G1), and the exercises will be delivered to the participants through a website with special accounts. The control group (G2) will receive a standard home exercise program in brochure format, showing the number of sets and repetitions. The exercise program will be performed at home three times a week for 8 weeks.

Evaluating the Role of Step Counts in Predicting Readmission and Mortality

This study investigates the relationship between physical activity, heart rate, and sleep quality with recurrent hospitalizations among discharged oncology patients. Following discharge, patients will wear Huawei smartwatches to enable daily tracking of step count, heart rate, and sleep duration through a connected smartphone app. Patients will also complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index during follow-up visits. The smartwatch monitoring will occur during the first 30 days post-discharge, while overall patient follow-up will extend up to 90 days. This study aims to determine if lower levels of home mobility, as indicated by step count and other activity metrics, correlate with an increased risk of hospital readmission within the 30-90 day period.

A Paradigm Shift in Musculoskeletal Rehabilitation Assessment After ACL Reconstruction Using Near-Infrared Spectroscopy

This study aims to establish and compare muscle haemodynamic response patterns in physically active subjects with anterior cruciate ligament (ACL) reconstruction, at different time points after surgery, against healthy controls, using 24 non-invasive near-infrared spectroscopy (NIRS) devices simultaneously during a single incremental interval cycling test. Muscle haemodynamics has so far been assessed using at most 2-3 near-infrared spectroscopy devices on isolated muscles and without correlating variables. At the same time, research on musculoskeletal pathologies is limited, and there are no studies that analyse the haemodynamic changes that occur when the anterior cruciate ligament (ACL) is injured and whether these changes last over time. This is a multicentre, observational, case-control, cross-sectional study, approved by the Clinical Research Ethics Committee of the Arnau de Vilanova University Hospital (CEIC-3203), that will include males aged 18-65 years who have undergone ACL reconstruction, divided into three groups: less than 6 months since surgery (ACL1), more than 2 years since surgery with normalised physical activity (ACL2), and a healthy control group with no history of ACL injury. Recruitment has not yet started and is expected to begin in October 2026

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.

A Study to See if an Energy Drink With Caffeine and Green Tea Increases Fat Burning When Exercising

The goal of this study is to evaluate the influence of consuming a drink containing a combination of caffeine and green tea extracts on fat oxidation responses at rest, during and after a period of endurance type exercise.

A School-Based Nutrition and Fitness Program: Operation ToneUp

The goal of this clinical trial is to learn if a school-based intervention, Operation ToneUp, can improve nutrition knowledge, fitness, and blood pressure in schoolchildren enrolled in grades 3-6. The main questions it aims to answer are: 1. Do students participating in the intervention show improved fitness, measured by upper body strength, core strength, and cardiovascular endurance? 2. Do students participating in the intervention show improved nutrition knowledge, measured by self-report? 3. Do students participating in the intervention show improved blood pressure, measured by blood pressure cuff? Researchers will compare students participating in the intervention to students at comparison schools to see if fitness, nutrition knowledge, and blood pressure differ. Participants in the intervention arm will complete two 20-minute web-based sessions focused on nutrition and fitness during class time. Participants in the comparison arm will not be exposed to Operation ToneUp. All participants will engage in pre- and post- testing including: * PE-teacher assessed push-ups, curl-ups, and PACER test * online self-reported nutrition knowledge assessments * nurse-recorded blood pressure

How a Single Workout Affects Gut Bugs in Women With Different Fitness Levels and Body Types

This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w/o obesity). The specific aims are as follows: * Aim 1: To examine the effects of acute aerobic exercise at 60-70% heart rate reserve (HRRmax) for 30 minutes bout on changes in the abundance of SCFA-producing bacteria and their functional downstream metabolic activity. * Aim 2: To examine the effects of acute aerobic exercise at 60-70% HRRmax 30-minute bout on changes in GM-released SCFA concentrations in stool and plasmatic metabolome.

Caffeine Supplementation and Strength Endurance in Brazilian Jiu-jitsu Athletes

This study investigated the acute effects of ingesting 400 mg of caffeine administered 30 minutes before Brazilian jiu-jitsu-specific strength endurance tests. Experienced athletes completed two conditions, placebo and caffeine, in a randomized, double-blind, crossover clinical trial. Performance was assessed using the dynamic component of the kimono grip strength test (maximum number of repetitions, MNR) and the isometric component (maximum static lift, MSL), both performed with a gi grip. Rating of perceived exertion, adverse effects, and blinding effectiveness were also evaluated.

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.

The Effect of Inspiratory Muscle Training With Substance Use Disorder

The aim was to investigate the effectiveness of inspiratory muscle training on dyspnoea, pulmonary function, respiratory muscle strength, cough capacity, functional exercise capacity, substance craving, depression, anxiety and quality of life in individuals with substance use disorder.

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.

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.

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.

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.