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Fatigue clinical trials

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NCT ID: NCT03724331 Active, not recruiting - Lung Cancer Clinical Trials

Understanding the Post-Surgical Non-Small Cell Lung Cancer Patient's Symptom Experience

Start date: June 4, 2019
Phase: N/A
Study type: Interventional

Among 13 core symptoms across 3,106 breast, colorectal, prostate, and lung cancer patients, persons with lung cancer were the most symptomatic, with moderate to severe fatigue being reported with the greatest prevalence. This is a proposed randomized controlled trial of a novel rehabilitative intervention for persons with non-small cell lung cancer after surgery that promotes self-management of cancer-related fatigue (CRF) and is practical, portable, low cost, and safe. The results of the study will provide a novel exercise intervention, and its optimal timing, that helps a vulnerable population by reducing CRF severity and fatigability and is applicable to nearly all post-thoracotomy lung cancer patients.

NCT ID: NCT03712592 Completed - Muscle Fatigue Clinical Trials

Physiological Constraints Associated With Trail Running

UT4M2018
Start date: July 23, 2018
Phase: N/A
Study type: Interventional

The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average altitude). Some studies have allowed the last 10 years to initiate the exploration of the physiological consequences of this type of practice, especially from a muscular point of view. However, some important questions remain to be clarified such as the impact of these sports events on fatigue and muscle recovery, cardiovascular, energy and water balance disturbances caused, induced sleep changes and the kinetics of recovery of the various parameters. . These elements remain in particular to be studied in very different racing contexts as currently developed by the organizers, namely race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days, 4 x 40 km) as encountered in the Grenoble UT4M race (Ultra Tour des 4 Massifs).

NCT ID: NCT03691987 Completed - Clinical trials for Chronic Fatigue Syndrome

The Comeback Study

Start date: February 15, 2019
Phase: Phase 2
Study type: Interventional

This is a single-center stratified (on gender and donor), block randomized, placebo-controlled, parallel group trial with 12-months follow-up of 80 chronic fatigue syndrome/encephalomyelitis (CFS/ME) participants. Participants will be randomized to treatment by preprocessed thawed donor fecal microbiota transplant or preprocessed thawed autologous fecal microbiota transplant. Primary endpoint is the efficacy of FMT at three months by the Fatigue Severity Scale. The investigators will use patient reported outcomes for primary and secondary outcome measures. Previous studies suggest that a dysbiosis of the gut microbiota may be a key feature in CFS/ME. We hypothesize that A: CFS/ME is caused by a dysbiosis in the gut flora causing barrier leakage of bacterial products, a low grade systemic immune activation and disturbances in the host energy metabolism. B: Recovery of a normal gut flora by fecal microbiota transplantation (FMT) alleviates symptoms and may even induce remission of CFS/ME. This project aims to determine if there is a true cause and effect relationship between a dysbiotic gut flora and CFS/ME by testing if treatment of the observed dysbiosis by FMT also can resolve CFS/ME symptoms. In this process, collection of blood, fecal, and urine samples before and after FMT will open the possibility to explore the relationship between the gut flora, immune response, host energy metabolism and CFS/ME using technologies of microbiomics, metabolomics and immunological characterizations for a better understanding of the pathobiology of CFS/ME.

NCT ID: NCT03684369 Withdrawn - Multiple Sclerosis Clinical Trials

Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy

Start date: July 2020
Phase: N/A
Study type: Interventional

The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.

NCT ID: NCT03675087 Recruiting - Clinical trials for Fatigue Syndrome, Chronic

Assessment of Exercise Response in Chronic Fatigue Syndrome / Myalgic Encephalomyelitis.

Start date: February 27, 2019
Phase:
Study type: Observational

This study evaluates the correlation between the 6-min walking test (6MWT) with gases measurement, and the peak cardiopulmonary exercise testing (CPET) using incremental cycling with gases and workload measurement, in order to determine if the 6MWT detects impairment in exercise tolerance and if it avoids the post-exertional malaise that the peak CPET causes on decreasing levels of physical activity, in participants affected by chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME). Physical activity level at baseline (usual activity, the parcipant will not be given any directions) will be recorded during 7 days, 24 hours/day. Afterwards, the 6MWT will be performed. After this test, the physical activity level will be collected again during 7 days, 24 hours/day. Peak CPET will be carried out 14 days after 6MWT to make sure that the basal levels are recovered, and finally, physical activity level will be collected again during 7 days, 24 hours/day.

NCT ID: NCT03674541 Completed - Fibromyalgia Clinical Trials

The Exercise Response to Pharmacologic Cholinergic Stimulation in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

Start date: January 14, 2020
Phase: Phase 2
Study type: Interventional

Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS), otherwise known as Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME), is an under-recognized disorder whose cause is not yet understood. Suggested theories behind the pathophysiology of this condition include autoimmune causes, an inciting viral illness, and a dysfunctional autonomic nervous system caused by a small fiber polyneuropathy. Symptoms include fatigue, cognitive impairments, gastrointestinal changes, exertional dyspnea, and post-exertional malaise. The latter two symptoms are caused in part by abnormal cardiopulmonary hemodynamics during exercise thought to be due to a small fiber polyneuropathy. This manifests as low biventricular filling pressures throughout exercise seen in patients undergoing an invasive cardiopulmonary exercise test (iCPET) along with small nerve fiber atrophy seen on skin biopsy. After diagnosis, patients are often treated with pyridostigmine (off-label use of this medication) to enhance cholinergic stimulation of norepinephrine release at the post-ganglionic synapse. This is thought to improve venoconstriction at the site of exercising muscles, leading to improved return of blood to the heart and increasing filling of the heart to more appropriate levels during peak exercise. Retrospective studies have shown that noninvasive measurements of exercise capacity, such as oxygen uptake, end-tidal carbon dioxide, and ventilatory efficiency, improve after treatment with pyridostigmine. To date, there are no studies that assess invasive hemodynamics after pyridostigmine administration. It is estimated that four million people suffer from ME/CFS worldwide, a number that is thought to be a gross underestimate of disease prevalence. However, despite its potential for debilitating symptoms, loss of productivity, and worldwide burden, the pathophysiology behind ME/CFS remains unknown and its treatment unclear. By evaluating the exercise response to cholinergic stimulation, this study will shed further light on the link between the autonomic nervous system and cardiopulmonary hemodynamics, potentially leading to new therapeutic targets.

NCT ID: NCT03662347 Recruiting - Multiple Sclerosis Clinical Trials

Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)

SeDiF_SEP
Start date: March 19, 2020
Phase:
Study type: Observational

Fatigue is the most common symptom and the most disabling symptom of Multiple Sclerosis, and its inefficient management can be a source of multiple consultations (increase in health costs) and a reduction in productivity (work stoppages). Hence the need to define the most effective therapeutic strategy to reduce fatigue in Multiple Sclerosis. One of the aims of this project is to provide clinical indicators that can serve as evaluation criteria for determining the most effective fatigue management strategy in Multiple Sclerosis. The primary objective of the study is to determine the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptomatic State (PASS) for fatigue in Multiple Sclerosis. The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).

NCT ID: NCT03655600 Terminated - Breast Cancer Clinical Trials

Acupressure for Pain and Opioid Use Among Breast Cancer Patients

AcuPOP
Start date: September 17, 2018
Phase: N/A
Study type: Interventional

This study seeks to determine the feasibility of recruiting and training participants in self-acupressure, for women undergoing primary breast cancer surgery or delayed reconstruction surgery. The study seeks to determine also if self-acupressure is effective in reducing the need for opioids post-surgery and the effects on other life factors.

NCT ID: NCT03643406 Completed - Mental Fatigue Clinical Trials

The Effect of Mental Fatigue on Lower Limb Functional Performance Tests and Brain Activity in a Healthy Population

Start date: October 19, 2018
Phase: N/A
Study type: Interventional

Objective of the study The main objectives of this project are: 1. To assess the influence of mental fatigue on a return-to-play test battery in healthy population 2. To assess the influence of mental fatigue on brain functioning during a balance and reaction time task in healthy population In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population). The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. Thirteen healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a mental fatigue scale (M-VAS) and motivation scale. Next, the subjects will carry out a functional test battery (hop test, vertical jump test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (RPE) is measured to indicate how fatigued the participants feel because of the test battery; also, M-VAS is collected once more. Then, a short cognitive task (Flanker task) is followed by either a long intensive cognitive task (90 minutes Stroop task) or control task (90 minutes documentary). Afterwards, participants have to carry out the Flanker task, fill in M-VAS (2x), perform the same test battery, fill in session RPE and one final fatigue scale (Nasa TLX). Heart frequency and EEG will be measured continuously during the trials.

NCT ID: NCT03639259 Completed - Stroke Clinical Trials

Emotional and Cognitive Determinants of Post-stroke Fatigue

Start date: May 30, 2018
Phase:
Study type: Observational

Fatigue is a prevalent, prolonged and partly disabling symptom following cerebral stroke. The health services has little knowledge of fatigue, both in terms of what characterizes those affected, and with regard to how fatigue can be treated. Persons going through a stroke may experience impairments in cognitive functions such as attention and memory. This will often cause previously effortless activities of daily living to become strenuous and exhausting. Experiencing a stroke will also in many cases lead to a major change in life due to other related loss of function, grief and health-related concerns. Emotional reactions like depression and anxiety are widespread. Specific knowledge of how cognitive impairment, emotional reactions and coping strategies contribute to development and maintenance of fatigue is lacking. The present research project will contribute with new and important knowledge in this area. A total of 250 adults have been followed up after stroke with multiple examinations. Average age at the time of stroke was 70 years. The investigators now plan to follow them up three to four years after stroke. This provides a unique opportunity to investigate how depression and anxiety, over time, may be related to the experience of fatigue, cognitive impairment and negative coping strategies such as worrying and rumination. The investigators will use questionnaires and cognitive tests when examining these associations. Such new knowledge about cognitive and emotional factors related to the development of fatigue long-term after stroke may help determine who is at risk of developing symptoms of fatigue. Furthermore, it can shed light on possible preventional measures, and provide better suited advice to those affected by fatigue. This knowledge can also pave the way for new, research-based treatment methods.