Fatigue

Objectives Objective 1: To determine the effects of a 16-week remotely delivered Pilates intervention on walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Objective 2: To examine the impact of a 16-week remotely delivered Pilates intervention on depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Aim Aim 1: To assess whether the 16-week remotely delivered Pilates intervention significantly improves walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS Aim 2: To investigate whether the 16-week remotely delivered Pilates intervention significantly improves depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Hypothesis Hypothesis 1: The 16-week remotely delivered Pilates intervention will significantly improve walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Hypothesis 2: Participants receiving the 16-week remotely delivered Pilates intervention will demonstrate significantly greater improvements in depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.

Mito Map is a research tool that produces an Energy Score from information provided by a participant. This remote observational study has an initial enrollment target of 400 adults across seven prespecified cohorts: healthy comparison participants; broad mitochondrial disease; POLG-related disease; post-infectious or autonomic illness; Lyme disease or post-treatment Lyme disease syndrome; cancer or cancer-survivorship related fatigue; and other neuromuscular or persistent energy-limiting conditions. The broad mitochondrial cohort has an initial target of 100 participants, and each other cohort has an initial target of 50 participants. These are planning targets rather than caps. Participants complete a baseline assessment and repeated assessments about every two weeks for 12 weeks. Routine activity is designed to take about 5-10 minutes per week, although screening, consent, baseline setup, troubleshooting, or safety follow-up may take longer. Assessments include the Energy Score and protocolized home measures of physical function such as grip strength and five-times sit-to-stand performance, with an approved alternative when grip testing is unsuitable. Participants assigned to grip testing receive a study-provided hand-grip dynamometer at no cost. Optional compatible wearable data may be collected continuously when authorized and technically available. The study does not assign treatment, and research scores will not be used to make clinical decisions. The primary hypothesis is that, within the same participant, higher-than-usual Energy Score values will be associated with better-than-usual objective functional performance at matched assessments. Cohort comparisons, including POLG-specific analyses, are exploratory. A separately consented subset may use a study-provided Flic button to create timestamped symptom, context, or intervention markers with optional follow-up confirmation. The device module is not continuously monitored, does not assign treatment, and is not an emergency service.

The primary objective of this study is to evaluate the safety and efficacy of Redsenol-1 Plus on cancer-related fatigue (CRF) in adults. The change in the severity of CRF from baseline at week 12 will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale, and compared between Redsenol-1 Plus and placebo groups. Additionally, the safety and tolerability of Redsenol-1 Plus, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).

Perianesthesia (preoperative and postanesthesia care unit, PACU) nurses work rotating, often extended shifts that can disrupt sleep and increase fatigue, both of which are recognized threats to patient safety in high-acuity perioperative settings. Mindfulness, a trait-like capacity for present-moment, non-judgmental awareness, has been proposed as a psychological resource that may help nurses regulate attention and buffer the effects of sleep loss and fatigue on clinical performance. However, little is known about how sleep quality and quantity, shift-level fatigue, and mindfulness jointly relate to the day-to-day safety performance of perianesthesia nurses. This prospective, repeated-measures, single-center study examines the relationships among sleep, mindfulness, and shift-level safety performance among nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital. Approximately 25 to 40 perianesthesia nurses will be followed across 8 to 12 of their own shifts each, with a target of 250 to 300 evaluable shift-level observations. At baseline, nurses will complete a demographic form together with the Pittsburgh Sleep Quality Index (B-PSQI) and the Mindful Attention Awareness Scale (MAAS). Before each observed shift, nurses will complete a brief pre-shift sleep and sleepiness diary; after each shift they will complete a post-shift acute-fatigue and shift-characteristics form. For each observed shift, trained researchers will use a researcher-developed Perianesthesia Safety Process Observation Form to document adherence to, and deviations from, applicable safety-critical care processes. The primary outcome is the Shift-Level Perianesthesia Safety Deviation Rate, defined as the number of observed safety-process deviations divided by the number of applicable safety processes for that shift. Secondary outcomes include post-shift acute fatigue, the occurrence of near-miss events, and exploratory analyses of whether trait mindfulness moderates the associations between sleep/fatigue and safety performance. No patients are directly enrolled as research subjects; only nurses and their shifts are observed. Findings are expected to inform strategies to support nurse sleep, wellbeing, and safety-critical performance in perianesthesia settings.

The goal of this clinical trial is to learn if repetitive Transcranial Magnetic Stimulation (rTMS) of the left premotor cortex can lessen fatigue in patients with Multiple Sclerosis, and if this is a feasible intervention. It will also give further information on fatigue in Multiple Sclerosis. The main questions it aims to answer is: * Does premotor rTMS decrease fatigue symptoms in patients with Multiple Sclerosis? * Is the change in fatigue reflected in an altered balance between brain excitation and inhibition in the targeted premotor cortex? Researchers will compare real rTMS with sham rTMS (which does not stimulate with a magnetic field), to see if real rTMS works to alleviate fatigue. Participants will: * Receive real or sham rTMS for 30 minutes, 5 days in a row * Visit the clinic before and 6 days after for baseline and follow-up * Fill out on-line questionnaires 1 day and 4 weeks after the end of intervention * Undergo a total of 3 brain scans (Magnetic Resonance Imaging at ultra-high field), at baseline, end of intervention, and follow-up * Undergo lab neurophysiological measurements before and after the first intervention session * Keep a fatigue diary and wear an activity tracker in the period before and after the intervention

The goal of this clinical trial is to learn how wearing the Hypershell lower-limb exoskeleton affects perceived fatigue during everyday mobility activities in adults aged 65 years and older. The main questions it aims to answer are: * Does active assistance from the Hypershell reduce the development of perceived fatigue during repeated everyday mobility tasks? * Does wearing the Hypershell affect how long participants can perform the protocol and how many tasks they can complete before reaching a high level of fatigue? * How do participants perceive the usability, comfort, and overall experience of using the Hypershell? * What are the biomechanical and physiological responses from wearing the Hypershell? Researchers will compare two conditions: performing the mobility protocol without the Hypershell and wearing the Hypershell with active assistance. Participants will: * Attend one baseline session including questionnaires, physical tests, and familiarization with the Hypershell and study procedures. * Attend two experimental sessions in a randomized order, with at least one week between sessions. * Complete a laboratory-based mobility protocol including daily activities such as standing up from a chair, walking, stair climbing, slope walking, walking on uneven surfaces, carrying an object, and performing a cognitive task while walking. * Report their perceived fatigue throughout the protocol using the Borg CR10 scale. * Wear non-invasive sensors that measure physiological responses and movement during the experimental sessions. * Provide feedback about their experience using the HyperShell.

This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive transcranial magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue and other clinical characteristics related to mood and cognition before and after participants receive rTMS.

The cAPAble study aims to evaluate the impact of an adapted physical activity program on persistent fatigue in patients with inflammatory bowel disease in remission. This multicenter randomized study will include 120 participants. Participants will be randomly assigned to either a 6-month adapted physical activity program or usual care. Fatigue will be assessed using the FACIT-F questionnaire at 6 months.

This study aims to evaluate balance ability, core stability, functional capacity, lower extremity muscle strength, and fatigue levels in children diagnosed with central nervous system demyelinating diseases, in order to contribute to the development of evidence-based and individualized rehabilitation strategies.

Radicle Performance™ VKN: A randomized, double-blind, placebo controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes.

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Neuromuscular electrical stimulation (NMES) is widely used to improve muscle strength and mitigate atrophy. However, its clinical efficacy is often limited by early neuromuscular fatigue, muscle damage, and discomfort, which reduce patient tolerance and contraction time. Photobiomodulation (PBM) has emerged as a potential therapy to enhance muscle performance and accelerate recovery by minimizing fatigue and damage. Despite its potential, few studies have investigated the effects of PBM applied specifically before an NMES-evoked fatigue protocol. This randomized, double-blind, placebo-controlled trial aims to evaluate the acute effects of PBM on neuromuscular fatigue, muscle damage, and functional outcomes in healthy young subjects. Participants will receive either active PBM (cluster probe: 5 lasers 810nm/200mW; 4 LEDs 660nm/10mW; Total Energy: 249.6 J per limb) or sham treatment 5 minutes before a fatiguing NMES protocol (80 contractions at 20% MVIC, 80 Hz, 1ms pulse width) applied to the quadriceps muscle. Assessments will be performed at baseline, immediately post-intervention, and at 24h, 48h, and 72h post-intervention. Primary outcomes include maximum and evoked isometric strength, mechanical work, and electrical muscle activity. Secondary outcomes include muscle damage (ultrasound echo-intensity), delayed onset muscle soreness (DOMS), functional performance (unilateral vertical jump), and clinical discomfort. The study seeks to determine if PBM can effectively modulate NMES-induced fatigue and muscle damage, potentially optimizing its clinical application.

The goal of this clinical trial is to evaluate whether Nuvastatic can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy. The main questions it aims to answer are: Does Nuvastatic significantly reduce cancer-related fatigue compared to placebo? Is Nuvastatic safe and well tolerated in this patient population? Researchers will compare Nuvastatic vs placebo to see if Nuvastatic improves fatigue scores and maintains an acceptable safety profile. Participants will: Receive Nuvastatic or placebo sachets (3 times per day) for 3 cycles of 20 days each (total \~60 treatment days). Continue their standard first-line chemotherapy regimen. Provide blood samples for biomarkers (CEA, CA-125) at Screening and End of Treatment. Complete patient diaries and fatigue assessments as per protocol.

This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.

This study aims to evaluate the effects of interval exercise on metabolic and inflammatory responses, energy substrate utilization, and fatigue in trained female basketball players. High-intensity intermittent exercise is a key component of basketball performance and induces substantial metabolic and physiological stress. However, the acute relationships between exercise-induced metabolic changes, inflammatory responses, substrate utilization, and fatigue in female basketball players remain insufficiently understood. In this prospective interventional study, eligible female basketball players will complete a standardized interval exercise protocol designed to replicate the physiological demands of competitive basketball. Physiological, biochemical, and perceptual measurements will be collected before exercise, immediately after exercise, and during recovery. Primary outcomes include changes in metabolic and inflammatory biomarkers, energy substrate utilization, and fatigue-related responses. Secondary outcomes include selected physiological and performance-related variables associated with recovery from high-intensity interval exercise. The findings of this study will improve the understanding of the physiological responses to interval exercise in female basketball players and may contribute to the development of evidence-based training and recovery strategies aimed at optimizing performance and athlete health.

The goal of this research study is to learn about the effects of the RISE-YA intervention on cancer-related fatigue in young adults who are brain cancer survivors.

Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients. In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.

The goal of this clinical trial is to learn if daily supplementation with a Nepalese Pepper Extract (Zanthoxylum Armatum, ZA) can improve cognitive performance and gaming performance in action video gamers aged 16 to 39, when taken over an extended period. The main questions it aims to answer are: Does chronic (42-day) daily ZA supplementation improve speed of cognitive performance and reduce subjective mental fatigue? Do these effects translate into objective and self-reported improvements in gaming performance? Are there additional acute (within-session) effects at the end of a chronic supplementation period, on top of any chronic effect? Researchers will compare 275mg daily ZA supplementation to placebo to see if chronic ZA produces better cognitive performance and lower fatigue than placebo. Participants will: Complete a screening call and a training visit on the computerised cognitive tasks and gaming tasks Take a daily capsule (either ZA or placebo, depending on treatment order) each morning with food for 42 days, then switch to the other treatment for a further 42 days after a 2-week washout Attend four testing visits at the research centre: a baseline and an endpoint visit for each 42-day treatment period Avoid alcohol and energy drinks for 24 hours before each testing visit, and caffeine from waking Complete cognitive tests before dosing and 1 hour after dosing at each testing visit Complete mood and sleep questionnaires Wear a heart rate monitor at rest on arrival at each visit Complete gaming-specific tasks (aim training, MOBA character control, multi-tasking, finger tapping, Fitts' Law, multiple object tracking, collision prediction) Play their action video game of choice at home throughout each 42-day period and complete performance questionnaires

Postpartum women frequently experience impairments in sexual function, pelvic floor dysfunction, fatigue, and depressive symptoms, all of which may adversely affect their quality of life during the postpartum period. Although pelvic floor muscle training is recommended as part of postpartum rehabilitation, evidence regarding comprehensive physiotherapist-led exercise programmes specifically targeting postpartum sexual health remains limited. Furthermore, no standardized telerehabilitation programme has yet been evaluated using a randomized controlled trial design. The aim of this randomized controlled trial is to evaluate the effectiveness of the POSH-Ex (Postpartum Sexual Health Exercise) programme, a standardized 12-week physiotherapist-led telerehabilitation intervention designed to improve female sexual function and overall postpartum health after childbirth. Secondary objectives are to evaluate its effects on pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. A total of 84 postpartum women will be randomly allocated in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will complete supervised online exercise sessions twice weekly for 12 weeks, while participants in the control group will receive usual postpartum care. Outcome assessments will be performed at baseline and immediately after completion of the intervention. The primary outcome is female sexual function assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include pelvic floor muscle strength, physical activity, fatigue, depressive symptoms, health-related quality of life, and body composition. The findings are expected to provide high-quality evidence regarding the effectiveness of a standardized telerehabilitation programme for postpartum rehabilitation and may contribute to the development of evidence-based postpartum rehabilitation programmes and future clinical practice guidelines.

Radicle Energy™ DNB: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on fatigue and related health outcomes

This feasibility randomized controlled trial will assess the acceptability, feasibility, and preliminary effects of an integrated mindfulness and exercise eHealth intervention, eMindExCare, among prostate cancer patients undergoing active treatment in Hong Kong. Participants will be randomized in a 1:1 ratio to either an 8-week eMindExCare intervention or an enhanced health education attention-control programme. eMindExCare integrates culturally adapted Cantonese mindfulness practices with home-based aerobic and resistance exercise delivered through Zoom, supported by home practice, exercise logs, and weekly reminders. The enhanced health education control programme will match the intervention group in contact time and engagement but will not include progressive aerobic training, resistance-band prescription, stationary bike provision, or a structured mindfulness curriculum. Feasibility and acceptability outcomes will include eligibility, consent, randomization, attendance, retention, questionnaire completion, missing data, and adverse events. Preliminary outcomes will include sleep quality, fatigue, pain, physical activity, mindfulness, motivation for exercise, and quality of life assessed at baseline, immediately post-intervention at week 8, and 3 months post-intervention.

Radicle Women's Health DNSTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related women's health outcomes

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.

The purpose of this research study is to better understand how cancer-related fatigue affects patients and how it's discussed with providers. This information will be used to develop an educational resource (visual aid poster) that could help individuals and their providers talk about cancer-related fatigue and which may help individuals better manage this symptom.

Long COVID can cause persistent symptoms such as fatigue, cognitive difficulties commonly described as brain fog, reduced exercise tolerance, and impaired quality of life. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may help modulate brain activity in regions involved in cognition, fatigue, and executive function. The NEUROSTIM-LC study will evaluate the feasibility and potential effects of repeated tDCS sessions in adults with long COVID presenting fatigue and/or brain fog. Participants will receive 30 sessions of tDCS applied over the left dorsolateral prefrontal cortex. Assessments will be performed before and after the intervention to evaluate changes in quality of life, fatigue, cognitive function, brain metabolism, physical performance, autonomic function, sleep quality, psychological symptoms, respiratory function, and blood biomarkers.