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Fatigue clinical trials

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NCT ID: NCT06403397 Not yet recruiting - Patient Safety Clinical Trials

Assessing the Impact of Monitor Maintenance Package Utilization

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Bedside monitors are frequently used in monitoring vital signs of critically ill patients. Nurses working in healthcare facilities, especially in intensive care units, are required to manage devices with different alarm threshold values, categories, and types of alerts, leading to alarm fatigue. In response to this serious threat to patient safety, the FDA and The Joint Commission worked to develop strategies to address alarm fatigue in 2011. Alarm monitoring, identification of the cause, and silencing are typically performed by nurses. When reviewing alarm control studies in the literature, the CEASE care package developed by Levis et al. in 2019 was encountered. The tool was developed for personalized clinical alarm monitoring for the patient.

NCT ID: NCT06397950 Not yet recruiting - Schizophrenia Clinical Trials

Correlates of Fatigue in People With Schizophrenia

FIZO-2
Start date: May 2024
Phase:
Study type: Observational

The goal of this experimental prospective study is to build an explicative model of trait fatigue in adults with schizophrenia engaged in a psychosocial rehabilitation process. The main questions it aims to answer are: - Which factors amongst those evaluated explain the most of fatigue variance in people with schizophrenia? - Which clinical factors characterise the most fatigued participants compared to less fatigued participants? Participants will wear an accelerometer for seven days to assess their sedentary and physical activity behaviours as well as their sleep. After this, they will undergo an experimental visit, to asses: - Fatigue - Cognitive function - Tobacco and caffeine consumption - Fatigue catastrophizing - Sleep quality - Sarcopenia risk - Functional capacities - Handgrip strength - Quadriceps maximal strength and fatigability

NCT ID: NCT06393790 Not yet recruiting - Stress Clinical Trials

Strength Training Protocol in Fibromyalgia Women

FM PROTOCOL
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months. The origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes. In addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients. Therefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.

NCT ID: NCT06386133 Not yet recruiting - Multiple Sclerosis Clinical Trials

Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care

MSBoost
Start date: October 1, 2024
Phase: N/A
Study type: Interventional

The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS). The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution. Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program. Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time.

NCT ID: NCT06381557 Not yet recruiting - Clinical trials for Cancer-related Fatigue

Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules

CRF
Start date: May 1, 2024
Phase: Phase 4
Study type: Interventional

Traditional Chinese medicine(TCM) has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.

NCT ID: NCT06371352 Not yet recruiting - Bipolar Disorder Clinical Trials

Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

Start date: May 2024
Phase: N/A
Study type: Interventional

Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.

NCT ID: NCT06356142 Not yet recruiting - Clinical trials for Exercise Induced Fatigue

The Effects of Palmar Cooling on Repeated Sprinting Ability

Start date: June 1, 2024
Phase: Early Phase 1
Study type: Interventional

Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale.

NCT ID: NCT06354985 Not yet recruiting - Stroke Clinical Trials

Modafinil and Exercise for Post Stroke Fatigue

MODEX
Start date: October 2024
Phase: Phase 3
Study type: Interventional

A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke. Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has two main aims: 1. Test if Exercise Program One is better than Exercise Program Two 2. Test if Modafinil is better than a Sugar Pill As another aim, the investigators will also look at if combining Modafinil with exercise has any benefits. This study will take place at 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels. Participants will be assigned at random (like flipping a coin) to 1 of 4 groups: 1. Sugar Pill plus Exercise Program One 2. Sugar Pill plus Exercise Program Two 3. Modafinil plus Exercise Program One 4. Modafinil plus Exercise Program Two The treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months. The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke.

NCT ID: NCT06336525 Not yet recruiting - Insomnia Clinical Trials

Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.

Start date: May 1, 2024
Phase:
Study type: Observational

Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.

NCT ID: NCT06298786 Not yet recruiting - Fatigue Clinical Trials

Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).

F-6MMT
Start date: April 2024
Phase:
Study type: Observational

Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice. The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings.