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Fatigue clinical trials

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NCT ID: NCT06147050 Not yet recruiting - Long COVID Clinical Trials

Effect of Metformin in Reducing Fatigue in Long COVID in Adolescents

REVIVE
Start date: April 2024
Phase: Phase 3
Study type: Interventional

Long Covid is a multisystem condition comprising often severe symptoms that follow a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Long COVID often manifests as fatigue and neurocognitive impairment (also referred to as 'brain fog'). Based on two systematic reviews of Covid-19 cases in neonates, children and adolescents under 19 years of age, fatigue caused by Long Covid can persist for years and can lead to work disability and labour shortages, posing a public health emergency with lasting health, mental, and economic impacts. To date, no treatment has shown to be broadly effective for the treatment of Long Covid. An experimental study has demonstrated that metformin, a common diabetes drug, might reduce the incidence of long COVID if given during the acute phase of COVID-19. The study, however, did not look at whether metformin would be effective as a treatment for those who already have long COVID. It also did not report the results by age groups, so it is not clear if the effect of metformin differs for people younger than 35 years of age. Therefore, a pilot, adaptive randomized controlled trial, which will evaluate the feasibility of conducting a large platform trial and will also evaluate the efficacy and safety of using metformin (versus placebo, a look-alike substance with no active ingredient) in managing fatigue in long COVID adolescent patients with persistent (long term) features of fatigue (chronic fatigue syndrome) has been proposed.

NCT ID: NCT06137833 Not yet recruiting - Breast Cancer Clinical Trials

Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Adjuvant Chemotherapy

Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effect of the administration of APPORTAL® in addition to the SoC (recommended physical exercise), in patients with breast cancer, suffering from fatigue during adjuvant chemotherapy. The main questions it aims to answer are: - if the food supplement APPORTAL® can be of help in supporting the physiological energy level, against the fatigue symptom in cancer patients undergoing adjuvant chemotherapy; - if the supplementation with APPORTAL® can optimize the nutritional status, the muscular strength, the quality of life of the patient. Also, the patients' satisfaction on the product received, the adherence to treatment will be evaluated and the overall safety and tolerability of the study product. The patients will be asked to perform 3 study visits from baseline to the end of treatment (at 4 and 8 weeks after baseline) and a follow-up visit after 12 weeks from baseline. The main assessments at each visit will be: - physical examination, weight, Body Mass Index (BMI), body temperature (°C), heart rate, respiratory frequency, and systolic and diastolic blood pressure; - previous and concomitant treatments; - fatigue assessment through BFI questionnaire; - quality of life through questionnaire SF-12; - muscular strength (dynamometer) - Adverse Event check (from Visit 2) Moreover, at visit 1 (baseline) and at visit 3 (end of treatment) a blood sample will be collected to evaluate the blood metabolites. Telephonic follow-up will be done at 2 weeks, 6 weeks, 10 weeks to assess compliance and to recommendations on physical activity and to study treatment (only at 2 and 6 weeks) and tolerability/safety. Participants will receive the nutrition supplement or the placebo, in addition to the SoC (recommended physical exercise), for 8 weeks. Researchers will compare Apportal® and Placebo groups to see if the physiological energy level against the fatigue symptom, the nutritional status, the muscular strength, the quality of life of the patient improve after 8 weeks of treatment with APPORTAL® in addition to SoC (recommended physical exercise).

NCT ID: NCT06123806 Not yet recruiting - Clinical trials for Dialysis; Complications

Factors Affecting Dialysis Associated Fatigue

Start date: June 2024
Phase:
Study type: Observational

The aim of this study is to investigate the factors affecting hemodialysis-associated fatigue and their impact on the physical and emotional well-being of patients. By identifying these factors, Investigators can develop effective strategies to reduce fatigue and enhance the overall quality of life for hemodialysis patients.

NCT ID: NCT06105307 Not yet recruiting - Fatigue Clinical Trials

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

RN-SLEEP
Start date: February 20, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06100809 Not yet recruiting - Fatigue Clinical Trials

Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness/recovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.

NCT ID: NCT06082518 Not yet recruiting - COVID-19 Clinical Trials

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

PCS-HBOT
Start date: December 2023
Phase: N/A
Study type: Interventional

Over 500 million people have been infected with COVID-19, and to date, more than 6 million people have died. Many individuals who have recovered from COVID-19 continue to experience symptoms even after they have been "cured" of the disease. This condition is known as post COVID-19 condition, which can have serious health consequences. A common symptom among these individuals is chronic fatigue, characterized by persistent tiredness or lack of energy. This study aims to explore a novel treatment for symptoms of post COVID-19 condition, known as hyperbaric oxygen therapy. This approach has shown promise in helping people with post COVID-19 conditions and treating some other causes of fatigue. Hyperbaric oxygen therapy involves placing patients in a small chamber where they receive high oxygen gas levels. However, this treatment is expensive and time-consuming, and it is unclear if this treatment can be effectively assessed in a large-scale research study. This small study will help us decide if conducting a large research study is feasible. The investigators aim to assess if hyperbaric oxygen therapy can improve symptoms of post COVID-19 condition, such as fatigue.

NCT ID: NCT06011135 Not yet recruiting - Clinical trials for Chronic Fatigue Syndrome

Exploring Worry in CFS/ME

Start date: October 1, 2023
Phase:
Study type: Observational

This study will be building on the findings of Kalfas et al 2022 paper exploring the prevalence of generalised worry in patients with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) before and after Cognitive Behavioural Therapy (CBT). The research was conducted in South London and Maudsley NHS Foundation Trust's (SLaM) Persistent Physical Symptoms Research and Treatment Unit. Previous research has indicated a bidirectional relationship between fatigue and worry (Kalfas et al., 2022); the findings of this paper suggest both that many ME/CFS patients experience comorbid problematic generalised worry and that there is a positive association between severity of worry and levels of fatigue (Kalfas et al, 2022). It appears that CBT for ME/CFS indirectly treats worry, however effect sizes are small to moderate, and treatment outcomes may improve if CBT treatments incorporate strategies that target generalised worry (Kalfas et al 2022). The aims of this project are to further explore worry in this group of patients through qualitative methods.

NCT ID: NCT05977179 Not yet recruiting - Fatigue Clinical Trials

Dietary Intervention to Mitigate Post-Acute COVID-19 Syndrome

Long-COVIDiet
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to conduct a 16-week randomized controlled trial aimed at investigating the effectiveness of the Whole-Diet Approach when following a healthy US-style diet rich in anti-inflammatory properties. The study will focus on evaluating its impact on reducing symptoms related to Post-Acute Sequelae of SARS-CoV-2 Infection (PACS) in adults aged 50 years and older. The main research questions this study aims to answer are: 1. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate fatigue symptoms in adults with PACS? 2. Does adhering to a healthy US-style diet, which is abundant in anti-inflammatory properties, effectively mitigate declines in muscle function and physical performance in adults with PACS? At the beginning of the study, eligible participants will be randomly assigned to either the Dietary Intervention Group, where they will receive personalized dietary plans and weekly sessions, or the Attention Control Group, where they will attend general health sessions on a weekly basis as well. This research intends to shed light on the potential benefits of the Whole-Diet Approach and its role in ameliorating PACS-related symptoms among older adults. By comparing the outcomes of the two groups, we hope to gain valuable insights into the effectiveness of this dietary intervention in improving the quality of life for individuals dealing with PACS.

NCT ID: NCT05967494 Not yet recruiting - Clinical trials for Chronic Fatigue Syndrome

Discovering Trends in Chronic Fatigue Syndrome Patients' Clinical Study Experiences

Start date: August 2024
Phase:
Study type: Observational

The study seeks to delve into the firsthand experiences of patients diagnosed with chronic fatigue syndrome who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. The data collected from this study will help improve future outcomes for all chronic fatigue syndrome patients as well as those in under-represented demographic groups.

NCT ID: NCT05909891 Not yet recruiting - Fatigue Clinical Trials

Treatment Adherence and Fatigue in Iron Deficiency

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

Iron Deficiency Anemia is an important health problem. Iron deficiency anemia constitutes half of the anemia seen in the world, and children and women constitute the group with iron deficiency anemia in our country (Internal Medicine Nursing Book with Case Scenarios, 2019; Turkey Program Guide as Iron). The treatment is iron replacement by oral or parenteral route (Guzelcuk, Ozbek, 2017). Due to the side effects of the drugs given in the treatment, the patients have difficulty in adapting to the treatment and there is a change in their fatigue levels (Guzelcuk, Özbek, 2017; Guide, 2019; Çipil, Demircioğlu, 2016). It is thought that the education given to the patients will increase their compliance with the treatment. It is thought that patients' hospital admissions and fatigue levels may change in the failure to comply with the treatment. In this study, the effect of the education given on the treatment compliance and fatigue of the patients will be investigated. This research will help patients with iron deficiency anemia whether they need education, the importance of treatment compliance and their fatigue levels.