Clinical Research Directory

Sex Differences in BDNF Study

A single bout of exercise can improve cognitive abilities like memory and attention. These functions help us navigate through everyday life. However, we do not fully understand how exercise improves cognitive abilities. We believe that exercise improves the brain by increasing the amount of BDNF in the blood. BDNF is very important for learning and memory. However, we still do not know if BDNF responds differently to exercise between females and males. The purpose of this work is to characterize potential sex-differences in the circulating BDNF response to acute exercise. We will test the hypothesis that males will have greater serum and plasma BDNF responses compared to females following a maximal exercise test.

Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults

This randomized controlled trial will investigate the effects of different aquatic power training dosing strategies and creatine supplementation on functional and multisystem adaptations in community-dwelling older adults. Participants will be randomly allocated to one of five parallel groups: (1) aquatic power training regulated according to rating of perceived exertion during the first repetition (RPE-1) plus placebo; (2) aquatic power training using a conventional time-based dosing strategy plus placebo; (3) time-based aquatic power training plus creatine supplementation; (4) sedentary control plus placebo; or (5) sedentary control plus creatine supplementation. The intervention will last 16 weeks. Aquatic training will be performed three times per week for approximately 60 minutes per session. Participants allocated to creatine supplementation will receive 3 g/day of creatine monohydrate, whereas the corresponding placebo groups will receive a visually indistinguishable placebo following the same supplementation schedule. The primary outcomes will assess body composition, muscle strength, and functional capacity. Additional outcomes will examine bone health, cardiometabolic health, inflammatory and oxidative stress biomarkers, immune function, neurobiological and cognitive function, quality of life, sleep quality, psychological status, fatigue, and affective state. Assessments will be performed before and after the 16-week intervention.

Supplemental Blood Flow Restriction Training to Improve the Upper Extremity in Chronic Stroke

The leading cause of long-term disability worldwide is neurological conditions, with stroke specifically affecting nearly 800,000 individuals in the United States in 2019. These populations currently live with reduced functional ability due to reduced strength, motor control, and muscular endurance, thereby impairing their ability to perform tasks throughout the day. One of the common functional abilities lost is upper extremity (UE) function, which leads to decreased independence with activities of daily living (ADL), increased reliance on caregivers, and increased financial burden due to increased healthcare costs. Blood flow restriction therapy (BFR) is an innovative therapeutic intervention that may serve as a supplement to traditional interventions. Blood flow restriction therapy has shown promise in improving muscular hypertrophy, muscular strength, and functional outcome measures in those with and without neurologic conditions.

Physical Exercise Prehabilitation Program in mEtabolic suRgery

The goal of this clinical trial is to learn if an exercise program before bariatric surgery works to treat obesity, could improve physical condition and weight loss before bariatric surgery and induce a lifestyle behavior change. The main questions it aims to answer are: * Does a supervised exercise program lead to improved physical condition prior to bariatric surgery? * Does a supervised exercise program prior to bariatric surgery lead to reduced surgery related complications? * Does a supervised exercise program prior to bariatric surgery lead to maintained lifestyle changes after surgery? Participants will: * Receive either no training program or physical exercise training program twice a week, supervised by a physical therapist, for a duration of 8 weeks. * Have their fitness measured at the start and at the end of the 8 weeks, measured with a six minute walking test. * Fill in a survey on their perceived quality of life and exercise habits at the start of the trial, and at 1 year after surgery.

The Effect of Acupuncture on Sarcopenia and Obesity in Patients With Sarcopenic Obesity.

Sarcopenia is defined by the European Working Group on Sarcopenia in Older People (EWGSOP) as "a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength, carrying a risk of adverse outcomes such as physical disability, fractures, falls, impaired quality of life, and death. Obesity is classified according to the Body Mass Index (BMI), which is calculated by dividing weight in kilograms by the square of height in meters. According to the World Health Organization and most current guidelines for Western societies, obesity is defined as a BMI ≥ 30 kg/m². Sarcopenic obesity was first defined by Baumgartner as the co-occurrence of sarcopenia and obesity, measured using DEXA (10). Sarcopenic obesity is defined as the co-occurrence of high adiposity and sarcopenia; a term originally coined to describe low skeletal muscle mass, strength, and physical function, initially diagnosed in the elderly but present across the entire age spectrum. Combining the effects of both sarcopenia and obesity, sarcopenic obesity has been found to be associated with lower quality of life and greater disability, morbidity, and mortality compared to obesity or sarcopenia alone. Acupuncture is derived from the Latin words for needle (acus) and piercing (punctura). In Western languages, it is written as acupuncture. In traditional Chinese medicine, it is believed that diseases are caused by disturbances in the flow of life energy (Qi) circulating in channels called meridians in the body. Acupuncture aims to correct this disrupted energy flow by inserting needles into specific points along the meridians in the body. Numerous studies have reported that acupuncture is widely used in the treatment of obesity. Current evidence-based reviews have shown that acupuncture is effective in treating obesity. It has been suggested that acupuncture is an effective treatment for simple obesity rather than a placebo effect. The literature contains many studies on acupuncture in the treatment of obesity. However, there are no studies on acupuncture in sarcopenic obesity. Our study aimed to determine the effect of acupuncture on sarcopenia and obesity in patients with sarcopenic obesity.

Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery

Cesarean section is the most common inpatient surgical procedure worldwide, with rates continuing to rise; in Canada, approximately one in three births occur by cesarean. Despite its prevalence, there are no expectations for individuals who have undergone a cesarean section to seek out rehabilitation care. Physical recovery guidance and return to activity from a cesarean birth is poorly understood and inadequately supported, with most research focusing on immediate post-operative pain management within the hospital settings. Little attention has been given to long term physical recovery. Scar-related problems - such as tight or stuck scar tissue, sensitivity or discomfort around the scar, weakness in the abdominal muscles, and infertility or digestive complications - can severely affects the ability to complete daily activities and affect overall quality of life. Rehabilitation is a common and important part of recovery after most major orthopedic and abdominal surgeries. It can help reduce pain and complications, improve mobility, strength, and confidence in movement, and support a gradual return to physical activity. Just as importantly, rehabilitation helps individuals safely resume everyday responsibilities such as caring for their family, returning to work, and managing daily tasks. The purpose of this study is to examine whether one form of hands-on therapy results in greater improvements in scar comfort, mobility, and performance of daily activities compared with an alternative approach, when both are delivered alongside an identical exercise program. Participants will take part in an 8-week rehabilitation program following cesarean birth. Rehabilitation will be provided one-on-one by a qualified healthcare professional and will include a combination of in-person sessions and virtual (online) check-ins. In-person sessions will include education about recovery, hands-on therapy, and guided exercises. Virtual sessions will be used to answer questions, review progress, and ensure that exercises are being performed safely and correctly at home. To evaluate changes in recovery over time, participants will attend three assessment sessions: at baseline (week 0), mid-intervention (week 4), and post-intervention (week 8). During these sessions, researchers will collect information on: * How the scar looks and moves * The sensitivity or discomfort of the scar area * How easily participants can perform everyday movements, such as standing up from a chair * How participants feel about their scar, pain levels, and daily function There will be two forms off assessments. One that measures the objective changes: photographs of the scar, gentle pressure testing to measure sensitivity, simple movement tests, and ultrasound imaging, while the other form of assessment is patient reported questionnaires about how they feel they are improving. Ultrasound is a safe and painless technique that allows researchers to see how tissues under the skin are healing and moving. The anticipated benefit of this research is to improve understanding of physical recovery after cesarean birth. The results may help inform future rehabilitation recommendations and contribute to better support for individuals recovering from cesarean surgery.

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.

Audiovisual Conditions During Eight Weeks of BOSU Training in Taekwondo Athletes

This nonrandomized three-group study described changes in taekwondo-specific electronic impact scores, selective attention and repeated-sprint performance over eight weeks of supplementary BOSU ball balance and proprioception training delivered under three different audiovisual conditions. Athletes were recruited from three taekwondo clubs in Malatya, Turkiye, and each club trained under one condition: high-tempo music (140-160 beats per minute) combined with projected elite competition footage (MV), low-tempo music alone (110-130 beats per minute; LTM), or no music and no video (CON). All three groups completed the same BOSU programme, three sessions per week for eight weeks (24 planned sessions of 40-45 minutes), in addition to their usual taekwondo training. Assessments were conducted at week 1, week 4 and week 8. Because allocation was not randomized and each condition was delivered predominantly within one club, audiovisual condition is confounded with club and the analyses are exploratory and descriptive rather than causal.

Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects

The aim of this protocol is to assess physiological responses during various physical exercise protocols (whole-body exercise such as cycling or treadmill running, or localised exercise such as knee extension) and during inhalation of a gas mixtures with various oxygen contents (similar to exposure at high altitude).

Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy.

Gamified Versus Regular Exercise Snacks on Stationary Bikes, as One 10-Minute or Two 5-Minute Sessions a Day, for Children in an Inclusive Primary School

The goal of this pilot clinical trial is to learn how short exercise breaks, often called exercise snacks, on stationary exercise bikes can best be offered during the school day to students in Primary 4 to 6 at an inclusive primary school in Macao, including autistic students. It will also learn whether the program is practical and safe in an inclusive school. The main questions it aims to answer are: When the bike screen shows a game with points and a ranking among the four riders in the group, do students ride farther per scheduled minute than when the same screen shows a regular display with a cartoon cyclist, heart rate, distance and time remaining? Is any extra riding on game days larger when the 10 minutes are ridden at once than when they are split into two 5-minute rides, and is it accompanied by better or worse feelings during and after the ride? When the same 10 minutes are split into two 5-minute rides, do students receive the same riding dose and are they as focused on their classwork afterwards? How many planned rides actually happen and are completed, and what support do autistic students need? The investigators expect students to ride more on game days. Whether that extra riding comes with better or worse feelings, and whether it depends on ride length. The comparison with the waitlist group only estimates how large the differences are, to help plan a larger study. Thirty-two riders ride in fixed groups of four on 3 fixed school days a week for 8 weeks, 10 minutes a day: one 10-minute ride a day for 4 weeks and two 5-minute rides a day for the other 4 weeks. Within each 4-week period, the display shown to a group on each riding day is randomly assigned, with equal numbers of game and regular-display days, and the same virtual tracks are used under both displays. Riders wear a heart-rate arm band and answer a few picture-supported questions before, during and after each ride. Trained observers, who do not know which display or schedule students are on, record how focused students are on their classwork in the lesson after riding. Sixteen waitlist students follow the usual school routine, complete the same assessments, and receive access to the bikes after the study. All students complete a short tablet attention task and questionnaires about exercise motivation and quality of life before and after the 8 weeks.

Thyroid Hormone Responses to Repeated Wingate Exercise Versus a Non-Exercising Comparison Group

This two-group, non-randomized study investigated the acute effects of repeated Wingate exercise on free thyroid hormone concentrations in male amateur soccer players. Twenty healthy male amateur soccer players completed a standardized repeated Wingate exercise protocol, and a separate group of twenty male amateur soccer players provided two morning blood samples without exercising. Blood samples were collected immediately before and immediately after the exercise session or the resting interval to determine free triiodothyronine (fT3), free thyroxine (fT4), and thyroid-stimulating hormone (TSH) concentrations. Including a non-exercising comparison group allows the observed changes to be evaluated against the change expected across a comparable interval in the absence of exercise.

Chrysin Exercise Performance Pilot Study

This single-arm pilot study evaluates within-subject changes in aerobic capacity, heart rate responses, cycling power output, and related physiological measures in healthy adults during and after 30 days of supplementation with a chrysin-based multi-flavonoid LipoMicel formulation containing chrysin, quercetin, and rutin.

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.

Effects of Mental Participation During Lumbar Stabilization and Neuromuscular Electrical Stimulation in Chronic Non-Specific Low Back Pain

This study was conducted to investigate the effects of incorporating synchronized voluntary muscle activation and active motor engagement during neuromuscular electrical stimulation (NMES) into a lumbar stabilization exercise program in individuals with chronic non-specific low back pain. Thirty-six individuals with chronic non-specific low back pain were randomly assigned to two groups. Both groups participated in an 8-week lumbar stabilization exercise program combined with NMES, administered twice weekly. The experimental group performed synchronized voluntary muscle activation and active motor engagement during NMES, whereas the control group received NMES without voluntary muscle activation. Pain intensity, disability, trunk endurance, lumbopelvic motor control, stabilization parameters, depression, fear-avoidance beliefs, and trunk range of motion were assessed to evaluate the effects of the intervention.

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.

AfterBabyBodyStudy- Testing Manual Examination Methods and Exercise Effects on Muscular Recovery After Pregnancy

Exercising postpartum is important for the health of mother and child. However, there are physical changes postpartum which can prevent women from exercising postpartum. About 30% of women postpartum have problems with stress urinary incontinence. Almost as many have a remaining separation of the two parts of the muscle rectus abdominis. Over the last decenium there has been an increased interest but also disparate information about these conditions. This has led to an increased uncertainty among women who wants to resume exercising postpartum. More and more women seek help of physiotherapists to verify an appropriate function in their muscles after pregnancy. However, reliable and valid examination methods are scarce and it is unclear how to interpret the examination results to give individualized exercise advice. The aim of this study is to test the reliability of examination methods for the pelvic floor function and separation of the rectus abdominis and the criterion validity of these examination methods regarding exercising without leaking urine and lumbopelvic pain. Another aim is to identify if exercising postpartum has effects on the function of the muscles and (less) leaking of urine and lumbopelvic pain/disability. Recruitment of 300 women approximately 8 weeks postpartum in the Region Västra Götaland. For testing interrater reliability on manual examination of the pelvic floor and the separation of the rectus abdominis by caliper two physiotherapists will examine the participants´ pelvic floor and abdominal muscles. The examinations will be tested for criterion validity using a questionnaire for pelvic floor function, lumbopelvic pain/disability and physical activity level. In an observational component of this study the questionnaire will also be used to evaluate the effects of exercising postpartum on the recovery of pelvic floor and abdominal muscles at 6, 9 and 12 months postpartum. This study will provide knowledge about the reliability of examination methods for pelvic floor function and separation of the rectus abdominis, their correlation to urinary leakage and pain/disability (criterion validity) and the effects of exercising on muscle function postpartum.

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.

Betaine Addition to Water Loading Prior to Running Exercise

This randomized, double-blind, placebo-controlled crossover study will investigate whether acute betaine ingestion as part of a pre-exercise hyperhydration strategy improves endurance running performance and influences hydration-related responses during prolonged exercise. Approximately 30 recreationally trained male and premenopausal female runners will complete two experimental trials: a betaine condition and a placebo/control condition. In the betaine condition, participants will ingest anhydrous betaine at a dose of 0.07 g/kg body mass as part of a standardized pre-exercise hydration protocol providing a total fluid intake of approximately 25 mL/kg body mass. Following the hydration protocol, participants will complete 60 minutes of treadmill running at 60% of the running velocity corresponding to VO₂max, followed by a 5-minute recovery period and a 5-km treadmill time trial. The primary outcome will be 5-km running time-trial performance. Secondary outcomes will include exercise-induced fluid and sweat loss, urinary hydration markers, sweat electrolyte concentrations, physiological responses, exercise economy, substrate utilization, blood lactate concentration, perceived exertion, thirst, and thermal sensation.

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).