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124 active trials for Fatigue

Abbott Brady 3T MRI PMCF

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

Start: October 2019

Acceptability, Feasibility and Preliminary Efficacy of CFWP to Treat Clinically Elevated Fatigue in Adults With CF

This research is being done to learn more ways to treat non-respiratory symptoms in people with CF including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.

Start: May 2021

Use of Audio Recordings of Self-Hypnosis and Meditation for Fatigue Management in Multiple Sclerosis

The purpose of this study is to assess the effectiveness of two self-guided psychological treatments, Self-Hypnosis (HYP) and Mindfulness Meditation (MM) compared to Treatment as Usual (TAU) for people with multiple sclerosis (MS) and clinically significant fatigue.

Start: April 2021

Cognitive Trance, Hypnosis and Meditation in Oncology

Patients with cancer often suffer from a symptom cluster, including pain, fatigue, sleep difficulties, emotional distress and cognitive impairments. In oncology settings, there is a growing interest in "mind-body" intervention, to relieve them in a non-pharmacological way. Hypnosis and meditation are two modified state of consciousness shown to positively this symptom cluster. Cognitive trance is also a modified state of consciousness, but is induced by body movements and/or vocalizations. Subjective reports of experts in cognitive trance showed a modification of self, emotion regulation, pain perception, attention and concentration. However, we still need to develop studies to better characterise this particular state of consciousness and its clinical applications. Our randomized-controlled trial aims at comparing both interventions in terms of (1) benefits on cancer patients' quality of life (pain, fatigue, sleep, distress, cognitive impairments), (2) phenomenological/subjective experiences and neurophysiological correlates, and (3) mechanisms involved in patients' responsiveness, based on the biopsychosocial model of hypnosis.

Start: January 2021

Light Therapy for PD - Dose Selection

This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day.

Start: September 2020

Understanding Mental Fatigue After Stroke

Mental fatigue is a major problem for stroke survivors and sometimes remains present years after the event. It is often rated as the most persisting and frustrating symptom. For many, mental fatigue has a significant negative effect on rehabilitation, and patients report difficulties with returning to previous levels of participation in their meaningful everyday activities whether at home, work or in the community. The development of effective evidence based interventions have been limited by our understanding of post stroke fatigue. This may be attributed to the fact that the underlying mechanisms for post stroke mental fatigue are unknown. Evolving theories suggest that mental fatigue may be associated with a dysfunction in the cognitive domain of attention. An impairment in the domain of attention may result in previously effortless activities of daily living that require sustained attention to become exhausting. Specific knowledge on the influence of background noise and other distractions on a person's ability to sustain attention after stroke is lacking. This research project will contribute to new and important knowledge in this area. A total of 30 adults will be reviewed at least 2 months after stroke on tasks that require sustained attention. The investigators plan to observe the influence background distraction has on the ability to do these tasks and whether wearing earphones will assist with concentration levels, and reduce fatiguing situations. This project provides a unique opportunity to investigate how a dysfunction in the cognitive domain of attention may be related to the experience of mental fatigue after stroke. The investigators will use a reaction time based test, fatigue questionnaires, alongside the wearing of earphones when examining associations. This knowledge may help to determine who is at risk of developing symptoms of mental fatigue. Furthermore, it may shed a light on possible prevention strategies, and provide more suitable guidance to those affected by mental fatigue.

Start: May 2021

Fatigue Levels in Fibromyalgia Syndrome

Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. The Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and determine the severity of the disease. The Fatigue Severity Scale (FSS) assessed the level and severity of fatigue. The short form of the International Physical Activity Questionnaire (IPAQ-SF) used to asess physical activity levels.The kinesiophobia level was assessed by using the Tampa Scale for Kinesiophobia.

Start: February 2021

Systematic Light Exposure for Fatigue in Breast Cancer Patients

Cancer related fatigue (CRF) is a stressful and constant tiredness related to cancer and/or its treatment. CRF is the most intense during treatment and can severely interfere with activities of daily living, such as tasks that require physical strength or thinking clearly. Prevalence of CRF has been reported to be as high as 94% during chemotherapy and as high as 34% five years after completion of treatment (Rotonda et al. 2013; Minton & Stone 2008). There is currently no generally-accepted treatment for CRF. However, there is evidence to suggest that light therapy can help with CRF. Non-pharmacological interventions for CRF have also been studied but are costly to implement and involve significant patient burden, particularly among those in active treatment. Given the clinical impact of CRF, the goal of this project is to investigate a novel, low-cost and low-burden intervention for Breast Cancer patients using a particular kind of light treatment called systematic light exposure (sLE) to treat CRF. Two hundred forty-eight breast cancer (BC) patients undergoing adjuvant or neoadjuvant chemotherapy will be recruited from Memorial Sloan Kettering Cancer Center, and City of Hope. The light will be administered by light glasses daily throughout entire duration of chemotherapy. Outcomes will be assessed at eight timepoints during chemo, and a series of follow up assessments at 1 week, 1-month, 3-months and 6-months post-chemotherapy. This study will have major public health relevance as it will determine if an easy-to-deliver, inexpensive, and low patient burden intervention effectively reduces CRF or prevents it from worsening during chemotherapy. Specific Aims: Aim 1: Determine if sLE prevents CRF from worsening in BC patients undergoing chemotherapy Aim 2: Determine whether sLE affects sleep, depression and circadian activity rhythms. Exploratory Aim 3: Investigate sLE normalizes circadian cortisol rhythms. Exploratory Aim 4: Examine whether the effects of sLE on fatigue are moderated/mediated by sleep quality, depression, and/or circadian rhythms.

Start: January 2018

The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients

The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.

Start: June 2019

Effect of Caffeine Supplementation and Personalized Insoles on Females

Several studies have shown the positive effect that caffeine has on athletic performance related variables. Nonetheless, most studies have been developed in males and have not studied the possible effects on biomechanics and related injuries. Moreover, the inclusion of personalized insoles could also affect biomechanical patterns and thus injury incidence that has shown to be higher when athletes are fatigued. Therefore, the aim of the present randomized controlled trial is to evaluate the effect of fatigue, caffeine supplementation and personalized insoles on biomechanics and athletic performance in female adult soccer players.

Start: December 2020

Gut Microbe Composition, Exercise, and Breast Breast Cancer Survivors

The primary goal of this project is to determine the effects of exercise on the gut microbiome in breast cancer survivors and determine how these changes may relate to psychosocial symptoms such as fatigue.

Start: January 2020

Lifestyle and Non-motor Symptom Management in Parkinson's Disease

Parkinson's Disease (PD) has generally been thought of as a movement disorder however other health-related symptoms, known as non-motor symptoms, are also very common. Non-motor symptoms can be very broad and present in numerous conditions, making identifying the symptoms of early-stage Parkinson's disease very difficult. Non-motor symptoms, including fatigue, and problems with sleep and mood, can happen decades before motor symptoms and have a greater impact on quality of life and psychological wellbeing. Despite this treatment options for non-motor symptoms are limited and therefore the development and testing of new treatments is a main priority. Due to the limited treatments options available, self-management of symptoms through positive lifestyle changes is a warranted area of research. The perspectives amongst patients, caregivers, and HCP's regarding lifestyle behavior change and its impact on fatigue and related non-motor symptoms has yet to be investigated in detail. This study includes two stages: telephone interviews and online consensus workshops. Patients with PD whom have experience of fatigue, partners/caregivers and Healthcare professionals will be able to participate in interviews only, workshops only or both. The interviews will investigate patients, partners/caregivers and Healthcare Professionals views and priorities of lifestyle factors in the management of non-motor symptoms in Parkinson's disease as well as identifying factors that influence lifestyle changes amongst PD patients. Stage 2 will involve small consensus workshops to generate ideas and feedback related to the design and content of the soon-to be developed lifestyle program. Results from both stages of this study will be used to help develop and design a lifestyle management program for fatigue and associated non-motor symptoms in Parkinson's Disease.

Start: May 2021

Apollo Device for Fatigue in Systemic Sclerosis

The purpose of this study is to learn about the effect of Apollo (a vibrating wearable about the side of an Apple Watch) on fatigue, Raynaud symptoms, depression, quality of life, and disease symptoms in patients with systemic sclerosis. SSc patients frequently have fatigue as a characteristic feature of their disease and fatigue negatively impacts quality of life (Haythornthwaite 2003, Richards 2003, Suarez-Almazor 2007, Basta 2017). The prevalence of fatigue among SSc patients is 75%, with 61% ranking fatigue among their top three most distressing complaints. Fatigue is also associated with poor sleep quality, greater pain and depressive symptoms (Sandusky 2009). We hypothesize that treatment with Apollo over 1 month will improve fatigue. If successful, the Apollo technology will be the first treatment option for fatigue and Raynaud's in this population.

Start: July 2020

High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV

This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 200 participants in Aurora, Colorado and Cleveland, Ohio, and includes 20 visits over a one-year period. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit.

Start: April 2021

Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals

Objective: Sympathetic activity starts to increase during exercise. At the end of the exercise, while sympathetic activation decreases, parasympathetic activity increases. Sympathetic and parasympathetic excursions achieve homeostasis. Most of the parasympathetic activity effects are vagus code. It is aimed to compare the comparison of exercise and vagus therapy in these healthy individuals.

Start: April 2021

Effectiveness of Recovery Protocols Combination in Soccer Players

The main objective of this project is to compare the effectiveness of combining different recovery methods on perceptual and physical performance on soccer players.

Start: April 2021

Effectiveness of Recovery Protocols in Elite Professional Young Soccer Players

The main objective of this project is to compare two recovery protocols, including nutritional and neuromuscular strategies on inmune, physiological and muscular responses.

Start: August 2021

The Role of Circadian Rhythms in Cancer-Related Symptoms

Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.

Start: June 2020

Effects of a Multimodal Physical Exercise and Functional Rehabilitation Program on Fatigue, Pain, Functional Capacity and Quality of Life in Cancer Patients With Tumor Asthenia.

Tumor asthenia is the most common symptom associated with cancer and its treatment. Although the estimated prevalence varies between 60-90%, and it is considered the longest-lasting symptom in cancer patients, having the greatest impact on quality of life parameters, it is a problem that is still undervalued in general by health professionals . It has been observed that individuals with this process find it difficult to normalize their daily life, either due to a deterioration in their clinical condition or due to a problem in the generalization of what they have learned during their hospital stay. That is why we plan to carry out a clinical trial, to evaluate the effect of a controlled patient follow-up program, and thus be able to address these difficulties in the most optimal way. A randomized clinical trial of two parallel groups will be carried out, belonging to the oncology service of the University Hospital of Salamanca. 44 participants with tumor asthenia, who are admitted at the time of inclusion, will be selected through a consecutive sampling. After the baseline evaluation, the participants will be randomized into two groups. The subjects of the experimental group will carry out a Functional Rehabilitation Program, with a duration of one month. The main variable will be the evaluation of the basic activities of daily life (Barthel scale). The secondary variables will be oriented to evaluate the change in tumor asthenia, attention and cognitive functions, parameters of quality of life, pain, functional capacity and body composition. The results of this study could be transferred to the clinic, incorporating them into care protocols for cancer patients with tumor asthenia.

Start: May 2021

Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patient

SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Its evolution can range from an asymptomatic course, to rapidly evolve and cause an acute respiratory syndrome. In addition to respiratory symptoms, is also has an impact on the neuromuscular systems. Therefore, the additional inactivity for hospitalization, negatively influences the loss of muscular, cardiovascular and metabolic fitness. In view of this, it is recommended that early post-acute rehabilitation be continued after the hospital phase to increase levels of physical activity, which can also be continued with long-term telerehabilitation. This project would offer a free service of asynchronous physical telerehabilitation for the patient that is easy to implement and follow up. For this purpose, patients will be recruited at the time of discharge from the Hospital Provincial Nuestra Señora de Gracia (HPNSG) and the Hospital Royo Villanova (HRV) in Zaragoza and two intervention groups with the same physical therapy and educational programme will be carried out. The experimental group will be carried out by means of home telerehabilitation, while the control group will receive the programme in an explanatory booklet. The main objective is to analyse the preliminary efficacy on physical fitness of a 12-week physical therapy and therapeutic education programme using asynchronous telerehabilitation in post-COVID-19 patients, and to compare its effects with patients who have undergone the same programme, but in a non-telematic format. The secondary objective is to analyze the feasibility of a physical home-based asynchronous telerehabilitation programme in post-COVID-19 patients. Hypothesis: the implementation of a 12-week programme of physical therapy and therapeutic education using asynchronous telerehabilitation software is feasible and preliminarily effective in increasing physical fitness as well as adherence to treatment, and in the improvement of psychosocial factors.

Start: April 2021