View clinical trials related to Fatigue Syndrome, Chronic.
Filter by:The aim of this multi-center, two-armed, randomized controlled trial is to assess the effect of a novel internet-based therapist-assisted treatment program "One step at a time" designed for the treatment of patients with moderate to severe functional somatic disorder (FSD). The trial will enroll 166 patients with FSD who will be randomized (1:1) to either the experimental condition (14 weeks' treatment with "One step at a time") or the active control condition ("GetStarted"), which is a non-guided internet-based treatment program for patients with FSD. The trial will include patients aged 18-60 years with an established single/oligo-organ or multi-organ FSD diagnosis, with a duration of minimum 6 months. The primary outcome measures will be based on self-reported physical health (SF-36 PPH) and treatment satisfaction (CGI-I). The trial will be considered effective if a higher proportion of patients in the experimental condition report a clinically significant outcome compared with patients in the active control condition at the 3-month follow-up after treatment.
The aim of the study is to investigate the effects of oral melatonin and zinc supplementation on core features in individuals with ME/CFS
This study aims to determine if low-dose naltrexone (LDN) reduces fatigue, improves related symptoms, and reduces inflammatory markers in peripheral blood in cases with Post-COVID-19 Fatigue Syndrome (PCFS) from COVID-19 (i.e. confirmed SARS-CoV-2 case). LDN refers to naltrexone given in doses of 1-4.5 mg. Overall, studies have found that LDN is safe and well-tolerated. It may help to reduce pain and inflammation and improve well-being and immune function.The trial will be conducted by the Complex Chronic Diseases Program (CCDP) at BC Women's Hospital and will demonstrate whether LDN could benefit a large number of people with PCFS.
The aims of this case-control, non-randomized study including patients with post-COVID-19 persisting symptoms are 1) to establish the large blood biobank, 2) to examine levels of circulating inflammatory biomarkers and different classes of non-coding RNAs (ncRNA), such as selected circRNAs and miRNAs, in plasma and serum samples collected from patients with post- COVID-19, 3) to test the levels of cfDNA in plasma and serum, 4) to define correlation between ncRNAs and cf-DNA with persistent clinical symptoms, and type of symptoms, and 5) to investigate diagnostic and prognostic performances of these circulating biomarkers. Study design. This is a prospective registry including biobank.
The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.
An association of fatigue with post-viral neuropsychological disturbs has been reported. Among patients hospitalized with COVID-19 there is an increased incidence of anxiety and depression symptoms. In addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (Mazza, M. G. et al 2020). The prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (PTSD) in a study conducted after the outbreak of the COVID-19 in Iran (Silmani et al, 2021), that showed 5.8% of subjects suffering from PTSD after 6 months of SARS-CoV-2 infection onset. In this Study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-COVID-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.
Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS/ME is a challenging health problem as well as a societal problem. In recent years, a doubling of the number of patients with a CFS/ME diagnoses has been reported in Norway. The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS/ME. Municipalities have expenses in form of care, rehabilitation and other measures. There is a lack of effective treatment for CFS/ME. Evidence-based knowledge is highly needed. If the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.
Rationale: A common feature in patients with Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are skeletal muscle-related symptoms, such as muscle pain, weakness, fatigue and post-exertional malaise. Objective: The primary aim is to determine markers for skeletal muscle structure and function, and circulating factors, in patients with PASC and ME/CFS, and compare with controls. The secondary objective is to determine skeletal muscle structure and function before and after induction of post-exertional malaise, and assess the relationships between the measures obtained from muscle biopsies and parameters of exercise tolerance. Study design: Case-control observational study Study population: Patients with PASC, ME/CFS and healthy human volunteers, 18 - 65 yr old. Intervention (if applicable): none Main study parameters/endpoints: Primary outcome parameters are markers for local inflammation, viral infiltration, mitochondrial respiratory function and myokine concentrations in a muscle biopsy and venous blood before and after induction of post-exertional malaise. Heart rate variability and measures of exercise performance will also be determined. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will be asked to perform physical exercise tests, give muscle biopsies (2 samples), and various blood samples. There is some extent of burden and risk associated with harvesting muscle biopsies and blood samples, however this will be mitigated by the fact that these procedures will only be carried out by trained physicians. Moreover, the scientific gain from obtaining intracellular information outweighs these relatively quick procedures with minimal discomfort afterwards. The acute risks of the physical exercise measurements are negligible. The main risk for patients is that these patients often suffer from post-exertional malaise, which causes the participants to feel fatigued for some time after the maximal exercise test. It is one of the aims to better understand post-exertional malaise.
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria. Diagnosis requires that the patient have the following three symptoms: 1. A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, 2. Post-exertional malaise,* and 3. Unrefreshing sleep* At least one of the two following manifestations is also required: 1. Cognitive impairment* or 2. Orthostatic intolerance Note* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity. Currently, individually tailored therapy with emphasis on cognitive behavioral therapy and graduated activity therapy is considered the therapy of first choice, although their effectiveness has been critically questioned in recent years. There are often frustrating treatment courses, a larger proportion of partial remissions, a significantly smaller proportion of full remissions and return to work. The study aims to evaluate patients of the outpatient service for chronic fatigue at the Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Switzerland, in the context of a group therapy for the treatment of CFS/ME in respect to the response to different, non-drug based therapeutic procedures and to gain knowledge about the effects of the therapy. The study is a clinical comparative study of therapeutic procedures/interventions without the use of drugs or a medical product. The interventions are Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL) adapted to CFS/ME. The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.
The aim of the study is to compare the effectiveness of two models of rehabilitation: - traditional neurological rehabilitation, and - neurological rehabilitation combined with a rehabilitation robot (Luna by EGZOTech). An additional goal is to test the qualitative diagnostic reference using the surface electromyogram of the Luna robot (certified as a Medical Device) for functional diagnostics based on standardized clinical tests.