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Fatigue clinical trials

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NCT ID: NCT05452096 Not yet recruiting - Quality of Life Clinical Trials

SHIFTPLAN: an RCT Investigating the Effect of a Shift Work Intervention on Fatigue, Sleep and Health.

SHIFTPLAN
Start date: October 2022
Phase: N/A
Study type: Interventional

Shift work is associated with disturbed life rhythms resulting from chronic exposure to circadian misalignment and sleep restriction, with long-term participation in most shift schedules causing serious health problems. Epidemiological data show that shift workers are at increased risk of sleepiness, fatigue and insomnia, cardiovascular disease, breast cancer and shift-work disorder. Prevalence estimates of shift-work disorder vary between 5% and 26,5%. Given these widespread and serious health and functional consequences of shift work, there is a necessity for treatments that improve shift workers' health and work performance. Most non-pharmacological recommendations mention improved scheduling, bright-light exposure, napping, psychoeducation fostering sleep hygiene, and cognitive-behavioral interventions. The effects of shift work on the health, fatigue and sleepiness of drivers have been robustly investigated in observational studies, as well as the effects of single measures such as scheduling or resting times. But studies on the effectiveness of countermeasures against the adverse impact of shift work are sparse, especially for high-risk populations such as professional drivers and controlled intervention studies are lacking. Several other investigators expounded the need for a multi-level approach to managing occupational sleep-related fatigue and workplace interventions to promote sleep and health of shift workers. Highlighting the high public-health burden associated with lack of recuperative sleep, the authors pointed out the pressing need to develop policies and implement programs aimed at improving workers' sleep health. With SHIFTPLAN, the investigators aim to fill this gap in comprehensive approaches. To their knowledge, this is the first randomised controlled trial to systematically gauge the effect of a multimodal program that includes ergonomic shift scheduling and an educational program on well-defined health, sleep and performance outcomes in professional drivers.

NCT ID: NCT05389189 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

A Tailored Psychological Intervention (MITIG.RA) for Managing Fatigue in Rheumatoid Arthritis

CoMIRA
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to examine the efficacy of the Compassion and Mindfulness Intervention for RA (MITIG.RA), a novel intervention combining different components of Cognitive Behavioural Therapy (CBT), compared to treatment-as-usual (TAU) in the management of Rheumatoid Arthritis (RA) associated fatigue. This is a multicentre, two-arm parallel randomized controlled trial. Patients will be screened for eligibility, willingness to participate, and will be assessed and randomized to the experimental (MITIG.RA + TAU) or control condition (TAU) using computer-randomization. MITIG.RA will be delivered by a certified psychologist and comprises eight sessions of 2 hours, followed by two booster sessions. Outcomes will be assessed via validated self-report measures and include levels of fatigue (primary outcome), perceived impact of disease, depressive symptoms, mindfulness, self-compassion, safety, and satisfaction (secondary outcomes). Assessment will take place at baseline, post-intervention, before the first and second booster session (week 12 and 20, respectively), and at 32 and 44 weeks after the interventions' beginning.

NCT ID: NCT05355493 Not yet recruiting - Mental Fatigue Clinical Trials

The Effect of Mental Fatigue on the Cerebral Oxygenation During Endurance Exercise

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The experiment will consist of 3 consecutive trials performed in a sound-insulated climate chamber (20°C and 40% RH) at the VUB. Participants will be asked to return 3 successive weeks. Trained staff (pre-doctoral researchers and trained master students) will be present during the experimental trials. The first visit will be a familiarization trial in which they will complete all procedures as if it was an experimental trial, except for the interventional 60min Stroop task. Instead of the 60-min Stroop task the participants' maximal cognitive capacity will be determined. The participant wil come in, perform a cognitive performance test, will then perform the intervention/control procedure, which will be followed by an additional conduction of the same cognitive performance test as before the intervention/control, as well as a physical performance test (time to exhaustion cycling test). The intervention will consist of a 60 min Stroop task, while the control trial will consist of watching a documentary of the same duration. Multiple different questionnaires (e.g. to assess the mentally fatigued state of participants) will be assessed throughout the experimental/control trial. The aim of this study will be to research if mental fatigue influences prefrontal cortex oxygenation during a time to exhaustion cycling test. Marcora et al. (2009) already showed a decrease in cycling performance during the exact same protocol.

NCT ID: NCT05333250 Not yet recruiting - Fatigue Clinical Trials

Modafinil to Improve Fatiguability

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

Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most commonly reported disabling symptoms experienced by patients with advanced cancer. However, there are currently limited evidence-based pharmacologic interventions available. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the effect of modafinil in managing CRF and CRCI, and to test the feasibility of carrying out the study.

NCT ID: NCT05319093 Not yet recruiting - Multiple Sclerosis Clinical Trials

Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients

Start date: April 2022
Phase:
Study type: Observational

Multi-center observational study to assess the short-term response of multiple sclerosis (MS) patients initiated on Ozanimod with respect to fatigue. Patterns of brain changes on brain magnetic resonance imaging (MRI) that might modulate the effect of Ozanimod treatment on fatigue will also be assessed.

NCT ID: NCT05315739 Not yet recruiting - Fatigue Clinical Trials

Vagus Nerve Stimulation for Systemic Lupus Erythematous

SLE-VNS
Start date: May 2022
Phase: N/A
Study type: Interventional

This trial uses a double blinded, randomized 1:1 (active:sham) placebo controlled, parallel group design, investigating the effects of transcutaneous vagus nerve stimulation (tVNS) in patients with systemic lupus erythematosus (SLE). The main objective is to evaluate whether adjuvant treatment with tVNS in SLE patients with signs of autonomic dysfunction and fatigue improves patient perceived levels of fatigue. Secondary outcomes include tVNS induced changes to: patient reported outcomes, autonomic nervous system function, SLE disease activity, immunologic profile, tolerability of pain and organ (cardiac, vascular and kidney) functions. Participants are randomized to received either active non-invasive transcutaneous vagus nerve stimulation (tVNS) or inactive sham stimulation. The study period is divided in two periods. The first period investigates the effects of short-term, high-intensity tVNS treatment. The second phase investigates the effects of long-term, middle-intensity tVNS treatment.

NCT ID: NCT05183815 Not yet recruiting - Clinical trials for Fatigue; Hemodialysis; Chronic Kidney Disease; Quality of Life

Effectiveness of Slow Back Stroke Massage and Murrotal Quran on Fatigue and Quality of Life of Patients Undergoing Haemodialysis

EMQ
Start date: January 25, 2022
Phase: N/A
Study type: Interventional

The study aimed to investigate the effectiveness of slow back stroke massage and murrotal Quran on fatigue and quality of life on patients undergoing hemodialysis.

NCT ID: NCT05146856 Not yet recruiting - Physician Fatigue Clinical Trials

Impact of a Day Without Clinical Activity Before Night Shift on Non-technical Skills of Intensive Care Residents

REPOPREGARD
Start date: December 2021
Phase:
Study type: Observational

In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be: To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule

NCT ID: NCT05002894 Not yet recruiting - Fatigue Clinical Trials

Effect of Pilates Exercises On Fatigue In Post Menopausal Women

Start date: September 2021
Phase: N/A
Study type: Interventional

Pilates is a system of exercises using special apparatus, designed to improve physical strength, flexibility, and enhance mental awareness. Regular exercise of post-menopausal women has benefits of increased cardio-respiratory fitness, increased muscle strength and endurance, reduced body fatigue, improved morale, and increased ability to perform daily tasks with greater force.Thus the main objective of regular exercise is prevention of physical deterioration and optimizing functional capacity to improve overall postmenopausal women's quality of life.

NCT ID: NCT04975087 Not yet recruiting - Clinical trials for Primary Sjögren's Syndrome

The Profile of Fatigue and Discomfort - Sicca Symptoms Inventory

Start date: October 15, 2021
Phase:
Study type: Observational

Primary Sjögren's syndrome (pSS) is a chronic, systemic autoimmune disease characterized by disorders of the lacrimal and salivary glands. The disease can be seen in systemic involvement by affecting any organ. It may result in skin, lung and kidney involvement as well as symptoms such as vasculitis and neuropathy. Patients with PSS often report fatigue as an important symptom to manage. Fatigue, defined as an overwhelming feeling of fatigue, lack of energy, and exhaustion, is associated with poor health and functional impairment. Fatigue is a common symptom of pSS. This symptom is the most important cause of loss of function in patients. It is thought that as a result of fatigue in pSS, decrease in mental health related to physical activity level and quality of life in patients, sleep problems, depression and loss of ability to work. Several mechanisms have been proposed to explain the occurrence of fatigue among sjogren patients, but its underlying physiological basis has not been adequately defined. Therefore, it is a complex, multifaceted and poorly understood symptom. In population-based studies, approximately 20% of healthy adults report experiencing fatigue, and this rate rises to 60%-70% among patients with autoimmune disorders. Fatigue is the most common non-exocrine symptom in pSS, and the prevalence of fatigue disability among patients with pSS has been reported to be approximately 70%.