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Fatigue clinical trials

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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: NCT06134219 Recruiting - Graves Disease Clinical Trials

Course for Brain Fatigue After Graves' Disease Controlled Study

MF-Course
Start date: October 10, 2023
Phase: N/A
Study type: Interventional

BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation. AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention. METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months. CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.

NCT ID: NCT06128668 Recruiting - Multiple Sclerosis Clinical Trials

The Effect of Yoga on Sleep Quality, Fatigue and Physical Activity Level of Multiple Sclerosis

Start date: November 25, 2023
Phase: N/A
Study type: Interventional

This randomized controlled study will be conducted to examine the effects of Yoga on Sleep, Fatigue and Physical Activity in Individuals Diagnosed with Relapsing-Remitting Multiple Sclerosis.

NCT ID: NCT06126627 Recruiting - Voice Disorders Clinical Trials

Brain and Voice Signatures in Teachers

BRAVO1
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Primary muscle tension dysphonia voice disorder with symptoms of vocal strain and vocal fatigue is common and can have a significant negative impact on quality of Life. Yet, primary muscle tension dysphonia's causes are unknown precluding precise diagnostic classification. Stress and personality are thought to play a role and thus, the project aims to determine the practical and clinical effect of stress on the control of voice and speech in the brain. Participants are female early career teachers and student teachers with symptoms of vocal fatigue, as well as control participants without vocal fatigue, who perform speech tasks on two different occasions. Neural (imaging of brain), psychobiological (saliva, personality), and voice and speech (muscle activity of voice muscles on the neck with surface sensors, audio recordings) data will compare reactivity patterns of teachers who are stressresponders with those who are nonresponders as well as control participants. The central hypothesis is that voice box stress responders have heightened emotion-motor activations involving the emotional voice production pathway, which correlate with changes in voice muscle activity in the anterior neck. The results will provide fundamentally missing data in our understanding of the role of stress in vocal complaints and will yield new insights about the neural underpinnings of primary muscle tension dysphonia. The study findings will have a significant impact on how clinicians identify so-called laryngoresponders to help them prevent voice disorders.

NCT ID: NCT06125353 Completed - Breast Cancer Clinical Trials

The Effect of Melatonin Supplementation on Fatigue Symptoms During Chemotherapy Treatment of Breast Cancer Patients

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

The aim of the present 3-month randomized, placebo-controlled trial was to evaluate whether adherence to Mediterranean Diet (MD) together with melatonin oral treatment or plaebo, would ameliorate Cancer Related Fatigue in Breast Cancer patients receiving chemotherapy treatment.

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: NCT06120101 Recruiting - Epilepsy Clinical Trials

Reflexology on Seizure Frequency, Fatigue, Stress and Sleep Quality in Epilepsy Patients

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

Epilepsy is among the diseases that cause loss of neurological abilities regardless of any trauma. Reflexology is one of the complementary therapies based on activating the body's self-healing power through special hand techniques applied to the feet. It is known that there are positive changes in seizure frequency, fatigue, stress and sleep quality in epilepsy patients after reflexology. This study will be conducted to determine the effect of reflexology on seizure frequency, fatigue, stress and sleep quality in epilepsy patients.

NCT ID: NCT06116708 Completed - Clinical trials for B52 Pilot Fatigue and Comfort

Kalogon Pilot Fatigue and Comfort Study

Start date: October 10, 2023
Phase: N/A
Study type: Interventional

The goal of this experimental study is to compare 2 different seat cushions in B52 cockpit seats to see if they affect pilot fatigue and comfort. The main questions it aims to answer are: 1. Does the Kalogon AF Prototype seat cushion improve pilot comfort compared to the standard seat cushion? 2. Does the Kalogon AF Prototype seat cushion reduce pilot fatigue compared to the standard cushion? Participants will spend 8 hours in a simulated cockpit playing a flight simulator. They will fill out multiple questionnaires and take 2 attention/reaction time tests throughout the 8-hours.

NCT ID: NCT06110637 Completed - Healthy Volunteers Clinical Trials

Effects of Running Shoe Sole Hardness on Vibration and Neuromuscular Fatigue During a Half-marathon Run on a Treadmill

FAT-VIB
Start date: June 15, 2022
Phase: N/A
Study type: Interventional

During running, each contact between the foot and the ground causes an impact. Ground reaction forces (GRF) are considered as an input into the musculoskeletal system. It involves a sudden deceleration in the lower limb packages (including muscles) which generates Soft-Tissue Vibrations (STV). The body is able to attenuate Soft-Tissue Vibrations (STV) but this capability decreases with fatigue. STV could be minimize by improving shoe midsole hardness.

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.