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....

Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore

The purpose of this research study is to investigate the acceptability, feasibility, and effectiveness of exercise therapy and cognitive behavioral therapy (CBT) in improving fatigue levels and breast cancer treatment adherence in breast cancer patients.

Patient-Centered Assessment of Symptoms and Outcomes

Background: The cause of fatigue is not well understood. It can be felt differently by different people. Some people think there are different types of fatigue, with different causes. Researchers think a therapy to treat one type of fatigue in one condition should be able to treat that type of fatigue in other conditions. Objective: To understand the types of fatigue. Eligibility: Adults 18 and older who have felt fatigue for more than a month, and non-fatigued adults Design: Participants will be screened with a physical exam, their medical history, a vision test, and blood and urine tests. Participants will begin to track the foods they eat. This study will involve up to 10 visits. Each visit will last no more than 4 hours. In Stage 1, participants will have an interview, fill out questionnaires, and play computer games. They will take walking and handgrip tests. They will give blood, urine, and saliva samples. They will wear a wrist monitor at home for 7 days and write down their activities. They will be put into a group: fatigue or non-fatigued control. In Stage 2, participants will answer questionnaires and give a blood sample. They will have heart tests. They may take exercise and lung function tests that include wearing a nose clip. They may have an optional brain MRI: They may wear an electrode cap on their head during the scan to measure brain activity. They will lie on table that slides into a cylinder. They may perform tasks in the scanner. After the study, participants might be contacted about other studies.

The Impact of Fatigue on Quality of Life and Activities of Daily Living in Pediatric Oncology Patients

This study aims to examine the impact of fatigue on the quality of life and daily living activities of children undergoing cancer treatment.In this cross-sectional study of 89 children aged 2-18 years, fatigue, quality of life, and functional independence were assessed using various scales.The basic hypothesis of the study is that as fatigue increases, children's daily activities and quality of life will be negatively affected.

High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV

This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 100 participants in Aurora, Colorado and Seattle, Washington. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit. The initial enrollment goal of 100 was increased to 120 in 2023 to facilitate a larger number of participants with key secondary outcomes.

TESTING AN MTM THEORY-BASED INTERVENTION ON REDUCING DROWSY DRIVING BEHAVIOR, "STAY AWAKE, STAY ALIVE ©," AMONG COLLEGE STUDENTS

The goal of this randomized controlled educational study is to learn whether a structured, theory-based program can help reduce drowsy driving among college students (18 years and older) in Nevada. Drowsy driving means driving when you are very sleepy, tired, or struggling to stay alert. It is a serious safety problem because it can slow reaction time, reduce attention, and increase the risk of crashes, injuries, and even deaths. Many college students have irregular sleep schedules due to classes, jobs, late-night studying, and social activities, which can increase tiredness and increase the likelihood of drowsy driving. Research question 1. Is there a statistically and practically significant difference in the mean score of drowsy driving behavior in the experimental group (Multi-Theory Model (MTM)-based intervention, Stay Awake, Stay Alive©) and the comparison group (standard AAA (American Automobile Association)program-based intervention) from pre-intervention to post-intervention to two-week follow-up 2. Is there a statistically and practically significant difference in the mean score (pre-intervention to post-intervention to two-week follow-up) for the intent to initiate reducing drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison (standard AAA program-based intervention) groups? 3. Is there a statistically and practically significant difference in the mean score (pre-intervention to post-intervention to two-week follow-up) for the intent to sustain the reduction of drowsy driving between the experimental (MTM-based intervention, Stay Awake, Stay Alive©) and comparison (standard AAA program-based intervention) groups? Researchers will compare two groups to see which approach leads to greater improvement: Group 1: MTM-based "Stay Awake, Stay Alive" program (interactive weekly sessions designed using behavior change theory). Group 2: Standard drowsy driving education program, AAA (American Automobile Association) based education. By comparing these groups, researchers can see whether the MTM-based program provides added benefit beyond standard education alone. Both groups receive the same overall time and attention, so differences in results can be linked more clearly to the program's strategies rather than to simply receiving education. Participants will: * Complete a short screening to confirm eligibility (for example, being 18+ and having recent experiences of drowsy driving) * Provide informed consent before any study activities begin * Be randomly assigned to one of the two programs * Attend four weekly sessions (about 75 minutes each) over 4 weeks, with a short break and refreshments during sessions * Complete surveys at three time points: Baseline (before the program begins), Post-intervention (after week 4), and Follow-up (after two weeks) * Answer questions about their drowsy driving behavior and related influences, such as fatigue triggers, barriers to sleep, confidence to avoid driving when sleepy, and supports that make safe choices easier. The study will measure changes in drowsy driving behavior and in MTM-related factors that may explain why these changes occur. For example, the MTM-based program helps students think about the benefits of avoiding drowsy driving (and the risks of continuing it), build behavioral confidence to choose safer options, and identify practical environmental supports (such as a safe place to rest, asking a friend for a ride, using ride-share or public transportation, or adjusting trip timing). It also supports emotional transformation (turning concern into motivation), practice for change (setting goals and tracking progress), and building a supportive social environment (friends and family encouraging safer choices). During the sessions, participants may learn and practice real-world skills such as recognizing early warning signs of sleepiness (heavy eyelids, frequent yawning, drifting lanes, missing exits), using short rest breaks and safe "pull-over" plans, managing schedules to reduce late-night driving, and creating a personal action plan for high-risk situations (after work shifts, long study nights, or long-distance travel). The follow-up survey helps researchers see whether any improvements continue beyond the end of the 4-week program. At the end of the study, results will help colleges, public health professionals, and road safety programs understand what types of education are most effective for preventing drowsy driving in young adults. If the MTM-based program is effective, it could be adapted and used more widely to improve student safety and reduce injuries related to drowsy driving. Participants who complete the final follow-up survey will receive an incentive.

ROBO-PAWS: Robot-Dog-Assisted Walking

Childhood cancers affect approximately 400,000 children and adolescents worldwide each year. Although advances in treatment have significantly improved survival rates, children undergoing cancer treatment continue to experience a wide range of treatment-related symptoms and complications. Among these, fatigue and sleep disturbances are particularly common and may persist throughout treatment and survivorship, negatively affecting psychological well-being, cognitive functioning, and overall quality of life. Reduced physical activity during treatment is strongly associated with worsening fatigue, impaired sleep, and decreased quality of life in pediatric oncology patients. However, treatment side effects, prolonged hospitalization, infection risk, and lack of motivating play-based activities often limit children's participation in physical activity during treatment. Recent evidence suggests that physical activity interventions may help reduce fatigue and improve well-being in children with cancer, yet engaging and age-appropriate non-pharmacological interventions remain limited, especially for younger children. This pilot randomized controlled trial aims to evaluate the feasibility and potential effects of a robot-dog-assisted walking intervention on sleep quality, fatigue, and quality of life among children aged 2-7 years undergoing cancer treatment.

Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES

Neuromuscular electrical stimulation (NMES) is widely used to improve muscle strength and mitigate atrophy. However, its clinical efficacy is often limited by early neuromuscular fatigue, muscle damage, and discomfort, which reduce patient tolerance and contraction time. Photobiomodulation (PBM) has emerged as a potential therapy to enhance muscle performance and accelerate recovery by minimizing fatigue and damage. Despite its potential, few studies have investigated the effects of PBM applied specifically before an NMES-evoked fatigue protocol. This randomized, double-blind, placebo-controlled trial aims to evaluate the acute effects of PBM on neuromuscular fatigue, muscle damage, and functional outcomes in healthy young subjects. Participants will receive either active PBM (cluster probe: 5 lasers 810nm/200mW; 4 LEDs 660nm/10mW; Total Energy: 249.6 J per limb) or sham treatment 5 minutes before a fatiguing NMES protocol (80 contractions at 20% MVIC, 80 Hz, 1ms pulse width) applied to the quadriceps muscle. Assessments will be performed at baseline, immediately post-intervention, and at 24h, 48h, and 72h post-intervention. Primary outcomes include maximum and evoked isometric strength, mechanical work, and electrical muscle activity. Secondary outcomes include muscle damage (ultrasound echo-intensity), delayed onset muscle soreness (DOMS), functional performance (unilateral vertical jump), and clinical discomfort. The study seeks to determine if PBM can effectively modulate NMES-induced fatigue and muscle damage, potentially optimizing its clinical application.

Hand Reflexology for Fatigue and Anxiety in Hemodialysis Patients

This randomized controlled trial evaluates the efficacy of hand reflexology massage (HRM) in reducing fatigue and anxiety among adult patients receiving maintenance hemodialysis. Participants are randomly assigned to either an HRM intervention group or a usual care control group. The HRM group receives eight 21-minute sessions of hand reflexology during routine hemodialysis visits over four weeks, while the control group continues with standard care only. Outcomes are measured using validated scales at baseline, mid-intervention (after 4 sessions), and post-intervention (after 8 sessions). This non-pharmacological, nurse-deliverable intervention is designed to be culturally appropriate, feasible in resource-limited settings, and respectful of patient comfort during dialysis.

Reflexology Versus Progressive Muscle Relaxation for Fatigue in Hemodialysis Patients

The goal of this clinical trial is to compare the effects of reflexology and progressive muscle relaxation in reducing fatigue among hemodialysis patients and to determine which intervention provides greater relief from fatigue. The main question it aims to answer is: Is there any difference in effectiveness between reflexology and progressive muscle relaxation techniques in reducing fatigue levels among patients undergoing hemodialysis? Participants will be randomly assigned to one of three groups: Group 1: 20 participants will receive reflexology therapy 3 times per week for 12 weeks. Group 2: 20 participants will receive progressive muscle relaxation 3 times per week for 12 weeks. Group 3: 20 participants will be a control group. Fatigue and sleep quality will be measured before and after the intervention using: Fatigue Severity Scale (FSS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS) This study aims to offer a safe, low-cost, non-pharmacological method that can help hemodialysis patients reduce fatigue and improve sleep quality.

A Multicentre Randomised Controlled Trial of the Norwegian Health in Work Service. The NSAC Efficacy Study

The Norwegian Sickness Absence Clinic (NSAC) is a publicly funded specialist outpatient health service, which is uniquely available for the work force. The overall aim of the NSAC is prevention of sickness absence, promote return to work (RTW) among those on sickness absence and prevent long term disability benefit dependency. In addition to being a health service, the NSAC has a focus on work and functional recovery, including also non-health related factors. Patients can be referred by general practitioners for mental health problems and musculoskeletal problems. The NSAC has a lower threshold for severity than specialist health services generally, and in particular for mental health problems. The efficacy of this service is unknown. The NSAC Efficacy Study is a randomized controlled multicentre trial which aims to assess the effect of the NSAC service. "Helse i Arbeid" is the Norwegian name for NSAC, and the Norwegian abbreviation is "HiA". The Norwegian study name is HIANOR. The NSAC Efficacy Study involves five different NSACs across northern Norway, and will recruit 2500 patients, randomized to in equal proportions to three treatment arms: 1. NSAC - rapid: treatment at the NSAC at- or within 4 weeks 2. NSAC - ordinary: treatment at the NSAC after 10-14 weeks 3. NSAC - active control: monodisciplinary examination at the NSAC close to diagnosis-specific deadline for examination as suggested by guidelines (8-26 weeks, the majority at the end of this interval) The overall aim is to assess the effect of the NSAC service, with the hypothesis that the NSAC service is superior to what resembles treatment as usual (TAU) for outcomes such as return to work or improved health (waiting list control). Many of the diagnoses or problems for which patients are referred to the NSACs naturally improve regardless of health interventions, and - as of date - no research has been conducted to assess the efficacy of the service.

Functional and Performance Determinants in Climbers: Examining the Role of Mobility, Stability, and Fatigue Across Proficiency Levels

The primary objective is to understand how motor skills and fatigue affect climbing performance in indoor and outdoor climbers, also comparing elite and amateur climbers. Aims: * Assess differences in selected joint range of motion, isometric strength, and dynamic stability between elite and intermediate climbers. * Evaluate the impact of the fatigue protocol on functional performance and cognitive outcomes across climbers of varying skill levels (intermediate vs. advanced). * Examine the impact of general joint hypermobility, as indicated by Beighton Scores, on functional climbing performance. * Association between cognitive factors (e.g., attention, memory) and motor skills. Research questions: * Do elite climbers have better joint mobility and balance than amateur climbers? * How does fatigue affect performance and reaction time and cognitive function? * Does having flexible joints (joint hypermobility) make climbers better athletes * What are the performance differences between indoor and outdoor climbers? This study will help identify key skills and physical traits that improve climbing performance. It will also explore how fatigue and flexibility impact safety and performance in different climbing environments.

Radicle Women's HealthTM: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal Symptoms

Radicle Women's HealthTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes among women experiencing menopausal symptoms.

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.

Conventional Vestibular Training Versus Immersive Virtual Reality- Based Vestibular in Multiple Sclerosis

The effectiveness of convectional vestibular training for balance and dizziness rehabilitation in people with multiple sclerosis has been recently demonstrated in a meta-analysis by this research team (doi: 10.3390/jcm9020590). Furthermore, non-immersive virtual reality-based environments seem to be useful for balance and gait rehabilitation in this population (doi: 10.1177/0269215518768084). However, nothing is known about the feasibility and effectiveness of immersive virtual reality-based rehabilitation in people with multiple sclerosis. The primary aim of this research is to determine the feasibility, safety and effectiveness of an immersive virtual reality-based vestibular training for dizziness, balance and fatigue rehabilitation, compared to conventional vestibular training.

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.

Association Between Sarcopenia, Fatigue and Orthostatic Intolerance in Geriatric Patients: A Case Control Study

This study aims to explore the relationship between sarcopenia, fatigue, and orthostatic intolerance in older adults. It will be conducted among geriatric patients attending Ain Shams University Hospitals. Participants aged 65 years and older will be divided into two groups: those with sarcopenia, diagnosed according to the European Working Group on Sarcopenia in Older People 2, and age- and sex-matched controls without sarcopenia. The study will compare levels of fatigue and the presence of orthostatic intolerance between the two groups. The findings are expected to improve understanding of how sarcopenia is associated with fatigue and orthostatic symptoms in the elderly population, which may help guide better clinical assessment and management.

Fatigability and Cognitive Demand With Aging

This study will determine the influence of a cognitive task performed during fatiguing contractions.

Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?

The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration \<7.0g/L) is a treatable cause of fatigue in people with MS: The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis. The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.

HEAlth Dialogues for Patients With Mental Illness in Primary Care

In the current project, primary health care patients with mental illness such as anxiety, depression, fatigue or sleep disorders will be followed. The study includes both health conversations with the health curve as a systematic work with lifestyle habits, and the biochemical risk marker copeptin with a focus on improved lifestyle habits and the development of cardiovascular complications. Participants will be followed up at 12 and 24 months with renewed health interview including the health curve and blood sampling. National registries will be used for a, up to 20 year long follow-up regarding cardiovascular complications and mortality.

Using Cognitive-Behavioral Change and Mobile Technology to Improve RN Sleep and Fatigue

The U.S. registered nurse (RN) workforce is the largest in the Healthcare and Social Assistance Sector and is at high risk for injuries and errors due to poor sleep and fatigue. Shift work (i.e., nights, evenings, rotating shifts) can contribute to RNs not obtaining adequate, restful sleep. Work intensity, including heavy physical and emotional workloads of caring for critically ill patients, can contribute to job stress, resulting in spill-over effects at home when RNs experience difficulties falling and staying asleep. To address work and home sleep barriers, this project proposes the development and pilot testing of RN-SLEEP, a skill-building mobile application designed to improve sleep. RN-SLEEP will provide a convenient, flexible space to learn sleep-enhancing evidence-based shift work-specific strategies, and cognitive-behavioral methods, (e.g., goal setting, relaxation training). Using NIOSH's Research 2 Practice (R2P) approach, the study team will collaborate with participants (N=18-24) from an RN union to refine RN-SLEEP content, integrating current sleep literature (including National Institute for Occupational Safety and Health \[NIOSH\] material) with cognitive-behavioral based training. RN-SLEEP will be pilot-tested using a two-group pretest-posttest study design, comparing sleep outcome measures (duration, quality) of RN-SLEEP participant users (n=38) with participants from an education control group (n=38). Data trends on fatigue, what drives behavior change (beliefs and self-efficacy), and other sleep outcome measures (timing, regularity, efficiency, daytime sleepiness) will be explored. RN-SLEEP goals align with Healthy People 2030, NIOSH's strategic goal to promote safe and healthy work design and well-being through two NIOSH Healthcare and Social Assistance Sector/Healthy Work Design Cross-Sector (HCSA/HWD) intermediate goals. HWD goal 7.2A is to conduct intervention research addressing fatigue (poor sleep sequela) due to suboptimal work designs (shift work) in the healthcare industry. HCSA/HWD goal 7.12A prioritizes interventions designed to impact work and non-work contributors to safety and health. This RN-SLEEP intervention aims to improve sleep by building skills that help RNs overcome obstacles to sleep from work and home, thus improving health and safety. Immediate outputs include a mobile app, designed and tested in collaboration with RNs, to improve sleep. Study results will be disseminated through our union collaborators, nursing conferences and journal publications, and our University's NIOSH-sponsored Education and Research Center social media outlets. Intermediate outcomes include enhancing RN sleep through training rarely available in nursing schools and traditional hospital health and safety training programs. Improving sleep can reduce fatigue and may decrease occupational injuries and errors. RN-SLEEP is adaptable, where future versions could be modified to meet the needs of other HCSA workers (i.e., nursing aides) and workers in other industries (e.g., oil and gas) scheduled to work non-standard work hours. End outcomes include integrating RN-SLEEP into a broader hospital organization intervention to mitigate fatigue risks.

Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study

This prospective longitudinal study will be conducted in patients diagnosed with Sjögren's disease who are followed at the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Demographic and clinical data will be collected from routine clinical assessments and medical records, including laboratory results obtained during standard care. Participants will undergo evaluation of pressure pain threshold using a digital algometer and complete validated questionnaires assessing fatigue, disease activity, patient-reported symptoms, anxiety and depression, pain catastrophizing, sleep quality, and physical activity level. All assessments will be performed at baseline and repeated at follow-up visits approximately 3 months later.

Vagal Nerve Stimulation for Post COVID Fatigue

The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.

MitoQ for Fatigue in Multiple Sclerosis (MS)

The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.