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124 active trials for Fatigue

Characterizing Fatigue Experienced by Registered Nurses

Background: Nursing is a high-stress job. It can be physically and mentally taxing. Nurses can have health problems due to long work hours, stressful work environments, and shift work. Fatigue is common among registered nurses (RNs). It has been linked with job burnout, missing work, injuries at work, and reduced job performance. Fatigue in RNs has been studied, but researchers want to learn more about it. Objectives: To learn more about how fatigue affects registered nurses. Eligibility: RNs at least 18 years old who work at NIH Design: Part 1: All RNs at the NIH will be invited to participate in an anonymous online survey. They will answer questions about their jobs and fatigue. Part 2: Fatigue levels in a small group of RNs will be evaluated more closely. They will be screened with questions by phone or in person. They will be asked about their work schedule, ability to speak and read English, and general health. Participants in Part 2 of the study will have 3 study visits. -Visit 1 will be at least 48 hours after the last time the participant worked. Participants will fast before the visit. They will have a medical history, physical exam, and blood tests. They will receive a food diary and a sleep watch and diary. They will wear the watch and complete the diaries for 1 week. Participants will answer questions on an iPad 2 times a day for 4 days. The first day will be when they complete visit 1. They then will do this for 3 workdays in a row. This will be right before and after work on those days. Questions will test their thinking and ask about their feelings. Visit 2 will be right after finishing 3 work days in a row. Participants will have blood pressure and blood samples taken. Visit 3 will be 1 week after finishing the diaries. Participants will return the sleep watch, iPad, and diaries A dietician may ask them questions about the food diary.

Start: April 2019

Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia

This phase II trial studies how well ruxolitinib phosphate works in reducing fatigue in patients with chronic lymphocytic leukemia. Ruxolitinib phosphate may stop the growth of cancer cells by blocking a protein called Janus kinase (JAK) that is needed for cell growth and may also help control fatigue, decrease the size of lymph nodes and/or lower the number of chronic lymphocytic leukemia cells in the blood.

Start: September 2014

ABC - A Post Intensive Care Anaemia Management Trial

On discharge from intensive care (ICU) patients are often severely anaemic (have a low level of haemoglobin (Hb) in their red blood cells (RBC)). Anaemia can persist for many months making patients feel tired and fatigued. Regaining pre-illness health and energy levels can take a long time. The ABC Post Intensive Care Trial will be the first trial to investigate if an anaemic ICU patient's health can be improved by treating with RBC transfusions following ICU discharge. We will compare the current approach as per national guidelines (restrictive transfusion), with a more active transfusion regime to correct anaemia from ICU discharge to hospital discharge. The trial will take place in acute hospitals throughout the UK where patients are discharged after a period of time in ICU. Patients discharged, or ready for discharge from ICU will be approached to consider participation in the trial. Once Hb level drops below 94g/L they would become eligible for inclusion (subject to meeting inclusion/exclusion criteria). The main indication for being excluded from participating in the trial is that transfusions are contraindicated (not appropriate for the patient) or they have an objection to blood transfusions. Group allocation will be randomly assigned at ICU discharge. We will explore which patients benefit most from transfusions and those who gain no benefit. Patients will have their Hb level checked at least weekly whilst in hospital and based on the result will have RBC transfusions as required according to the treatment regime they were randomised to. Part of the research is based on self-reported quality of life so participants will be asked to complete a number of questionnaires at set time-points from randomisation to 6 months post randomisation. Each participant will be actively on trial for approximately 6 months. The five-year follow will be done using routinely collected data from national databases.

Start: September 2020

Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II

The purpose of this study will to be to evaluate the effects of a mobile intervention focused on improving the chronic disease self management skills of individuals with low health literacy. The intervention will provide information that culturally and linguistically tailored to participants' level of health literacy.

Start: August 2018

The Effects of Light Therapy to Treat Cancer-related Side Effects

Severe fatigue, depression, sleep problems and cognitive impairment are the most commonly reported side effects of cancer treatment. These aversive side effects are hypothesized to be related to the disruption of circadian rhythms associated with cancer and its treatment. Exposure to Bright White Light (BWL) has been found to synchronize the circadian activity rhythms but research with cancer patients has been scarce. Therefore, the proposed randomized control trial (RCT) will test if systematic light exposure (sLE) will minimize overall levels of cancer-related fatigue (CRF), depression, sleep problems and cognitive impairment among breast cancer patients undergoing breast cancer treatment (i.e., surgery, chemotherapy). SLE incorporates the delivery of harmless UV-protected BWL or Dim White Light (DWL - standard comparison in light studies) delivered to patients by using special glasses for 30 minutes each morning, during their treatment. The proposed study, including a delineated comparison condition, will investigate the effects of BWL on CRF, sleep, depression, cognition, circadian rhythms, and inflammation markers among patients undergoing breast cancer treatment. The proposed RCT could have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention reduces common side effects (e.g., CRF, depression, cognitive impairment) of cancer treatment (i.e., surgery, chemotherapy). Aim 1 - Assess whether Bright White Light (BWL) compared with Dim White Light (DWL) among breast cancer patients undergoing breast cancer treatment will minimize overall levels of CRF, depression, sleep problems, and cognitive impairment during and after breast cancer treatment. Aim 2 - Determine whether the BWL intervention affects cortisol rhythms, circadian activity rhythms, melatonin rhythms, and inflammation markers that have been identified as correlates/causes of cancer-related side effects (e.g., CRF, depression, sleep problems). Aim 3 - Exploratory: Explore whether the effects of BWL compared to DWL on the cancer-related side effects (e.g., CRF, cognitive impairment) are mediated by the beneficial effects of the BWL in synchronizing circadian rhythms. Aim 4 - Exploratory: Explore potential moderators of the intervention including seasonality, chronobiology, personality, and social factors.

Start: June 2020

Open-Label Placebos to Treat Fatigue in Multiple Sclerosis

Fatigue is one of the most prevalent and disabling symptoms of multiple sclerosis. Current treatments, including pharmacological, physical therapy, sleep regulation and psychological interventions are of marginal benefit. Pharmacological treatments have inconsistent evidence. Recent studies show that non-deceptive open-label placebos (OLP) have moderate-to-large effects on symptoms, including fatigue, in adults with a variety of medical conditions. Hence, this is a pilot and feasibility study to obtain data on the feasibility and effects of OLP for multiple sclerosis related fatigue and its impact to provide the basis for a competitive NIH application. This pilot study will be the first study to evaluate whether OLP, that garners full consent and engages patients in their wellness, may offer a safe, effective treatment for multiple sclerosis related fatigue.

Start: February 2020

The Effects of Apathy on Different Forms of Fatigue

60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital and from the " Fragilily " Platform of the Nice University Hospital. After verification by the investigator, if they meet the inclusion criteria and sign the informed consent, participants will have to wear an actigraph for one week in order to measure their level of activity. Afterwards, participants will have to complete assessments and questionnaires to evaluate apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task), the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale). Regarding the activity level, they will also be asked to perform tasks to evaluate their kinematic movements( through an actigraph), and their particular sensitivity towards effort and reward (through serious game 'Tap-piscine'). The total duration of the evaluation is a maximum of 2 hours.

Start: January 2021

Obstructive Sleep Apnoea in Sarcoidosis

Sarcoidosis is a multisystemic granulomatous disease of unknown origin. Fatigue is a common problem in sarcoidosis affecting between 50% and 80% of patients, and thus represents a major impairment of their quality of life. The findings of recent studies suggest a high prevalence of obstructive sleep apnoea (OSA) in patients with sarcoidosis, estimating a range from 17% to 67%. Pathomechanisms leading to this increased OSA prevalence are still unclear, yet likely to be multifactorial including sarcoid myopathy and neuropathy leading to impaired integrity of the upper airways as well as corticosteroid induced obesity. While both diseases, Sarcoidosis and OSA, could lead to fatigue and excessive daytime sleepiness (EDS) the current managing strategies differ significantly. OSA patients are mostly treated with continuous positive airway pressure (CPAP) whereas sarcoidosis associated fatigue may require increased immunosuppressive therapy. Little is known about treatment of fatigue and sleepiness in patients suffering from both conditions.This study aims to close this knowledge gap and define prevalence of OSA in a swiss cohort with sarcoidosis patients. Therefore, we plan a prospective, observational, controlled study to investigate the prevalence of sleepiness, fatigue, life quality and obstructive sleep apnoea in patients with Sarcoidosis. Patients treated in the University Hospital Zurich due to sarcoidosis will be invited by letter to take part in this study. After confirmed consent and baseline assessments at the University Hospital Zurich, these patients will undergo a single night, in-home sleep study to assess possible OSA. Sleepiness and fatigue specific questionnaires and in-home respiratory polygraphy (oRP) are obtained in all subjects. To assess inflammation status and other conditions connected to sleepiness like hypothyroidism and anaemia, sarcoidosis patients will undergo blood sampling.

Start: October 2019

Feasibility of Adjunctive BLT for Amelioration of Fatigue in Chinese Cancer Patients Admitted to a Palliative Care Unit

Fatigue is the most common symptom in palliative care patients who have advanced cancer. Fatigue is also one of the most underreported hence under-treated symptoms. Patients may perceive it as a condition to be endured, whereas healthcare workers find it very challenging to assess and treat due to its subjective nature and multi-dimensional causes. However, evidence-based practice to tackle this distressing problem is still inadequate, and that a one-size fit all approach is unrealistic. Various pharmacological options have been examined, but due to limited evidence, no specific drug could be recommended. Latest development in management of fatigue includes non-pharmacological approach. Bright Light Treatment (BLT) has also evolved as a favourable treatment for cancer-related fatigue. BLT is the prescription of artificial bright light over a designated period of time. Recent clinical evidence showed that BLT reduced symptom of fatigue in patients undergoing active chemotherapy and cancer survivours. There is however no data on bright light therapy used in in-patient palliative care settings. A single group, prospective interventional study will be conducted in in-patient palliative care unit of Shatin Hospital (N = 42). The aim is to assess the feasibility and impact of BLT as an in-patient intervention in a cohort of local Chinese palliative care in-patients diagnosed with incurable cancer with documented symptom of fatigue, and to ascertain the changes of fatigue, mood, sleep and quality of life after 1-week exposure of BLT.

Start: August 2020

High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue

Fatigue is one of the most frequently reported and disabling impairments in multiple sclerosis (MS) and is associated with activity limitations, participation restrictions and reduced health-related quality of life (HRQL).MS fatigue is thought to be related to the disease itself, where increased levels of inflammatory biological markers (cytokines) are contributing. Resistance training may have an anti-inflammatory effect where a higher intensity is thought to have a more profound effect. Moderate-intensity resistance training is well tolerated in people with MS (PwMS) and can reduce self-reported fatigue. There is, however, a lack of high-quality studies including only fatigued PwMS when evaluating exercise regimes. Furthermore, the optimal dose (i.e. the combination of duration, frequency and intensity) is not known. Our hypothesis is that high-intensity resistance training will have positive effects in fatigued PwMS on functioning (fatigue, mood, activities and participation) and wellbeing/HRQL; and a positive immunomodulatory effect measured by inflammatory biological markers in blood. Further, that high-intensity resistance training twice a week will be superior to once a week

Start: August 2020

The Sleep and Teamwork in EMS Study

More than half of Emergency Medical Services (EMS) workers report work-related mental and physical fatigue. Odds of injury among fatigued EMS workers are nearly double that of non-fatigued workers. There is a compelling need to reduce fatigue among EMS workers, yet few EMS organizations have a formal fatigue management program and many may not be cost-effective or evidence-based. This trial addresses national goals of the National Occupational Research Agenda (NORA) and tests a novel approach to fatigue risk management that is easily scalable to large workforces and low-cost for employers of shift workers.

Start: September 2020

Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients

There is a paucity of studies that focus on the symptom burden of cancer patients in Singapore, particularly the clinical effects of cancer-related fatigue (CRF). Knowing that early-stage breast cancer is curable, it is of paramount importance to evaluate the clinical and biological determinants of lingering symptoms in breast cancer survivors so that appropriate psychosocial interventions can be formulated.

Start: October 2014

Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women

The aim of this study is to explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.

Start: August 2020

Lupus Intervention for Fatigue Trial

Participants in the Chicago Lupus Database or individuals seen at Northwestern Medicine will be approached to enroll in a one year clinical trial looking at decreasing fatigue in persons with systemic lupus erythematosus (SLE). The intervention group will receive individual coaching sessions focusing on physical activity and nutrition while the control group will receive individual calls in relation to SLE self-management educational sessions.This study is designed to evaluate the LIFT intervention to decrease fatigue (primary outcome), improve physical activity (secondary outcome) and dietary behavior (exploratory outcome) in persons with SLE.

Start: May 2019

Utility and Validity of a High-intensity, Intermittent Exercise Protocol

The purpose of this study is to identify an exercise-induced fatigue protocol to mimic central and peripheral acute fatigue effects associated with participation in vigorous dynamic sports activities and to understand the expected central (cardiovascular) and peripheral (muscular) impact of this protocol.

Start: September 2020

Swiss Frailty Network and Repository

Physical frailty is an age-related medical syndrome defined by a decline in multiple body systems, thus causing increased vulnerability, even in the face of minor stressors (1) It has been linked to multiple negative health outcomes, including extended length of stay in acute care due to complications, hospital re-admissions, and mortality among older patients. About 10-30% of community-dwelling seniors are considered frail(2) with an additional 40% being at risk for the condition (pre-frailty). By 2030, the number of older adults with frailty is expected to at least double, in parallel to the projected growth of the older segment of the population. Frail seniors consume 3-times more health care resources then their robust counterparts. Thus, the health economic impact of frailty is expected to be enormous and a call to action has been posed. Big data in healthcare provides important opportunities for the identification of frailty among the growing number of older patients. This is relevant as frailty is considered a better predictor of adverse outcomes than chronological age alone. Therefore, several medical specialties have started to assess frailty in cancer patients, heart surgery candidates and potential organ transplant recipients.

Start: June 2020

Insomnia Self-Management in Heart Failure

Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined. A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education. Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.

Start: October 2015

Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation

Physiological changes caused by hematological diseases associated with high dose chemotherapy have a negative impact on patient's functionality, making them more fragile and vulnerable after hematopoietic cell transplantation. Currently, randomized studies have shown that physical exercise can contribute to improve Quality of Life of these patients. In this randomized controlled trial, we will study the effect of using the bicycle ergometer on the physical performance of patients undergoing transplantation of hematopoietic stem cells (HSCT).

Start: March 2020

3D-HD Optic Systems Influence Surgical Performance

Randomized controlled trial in which two different laparoscopic systems: standard 2D and Olympus VISERA Elite II 3D will be compared in terms of laparoscopic skills, length of surgery, intraoperative complications and surgeon's fatigue in a group of senior surgeons and senior residents will be measured when performing laparoscopic Roux-en-Y gastric bypass.

Start: February 2020

The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.

Start: June 2015