Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 7:32 PM
Ignite Modification Date: 2025-12-24 @ 7:32 PM
NCT ID: NCT05502003
Brief Summary: The aim of this study is to evaluate the effect of telerehabilitation-based high-intensity interval upper extremity exercise training on biochemistry parameters and disease symptoms in fibromyalgia patients. It has been reported that substances such as serotonin and tryptophan are found at abnormal levels in the serotonergic system in patients with fibromyalgia, and symptoms such as depression, pain, and fatigue related to the disease may be associated with this condition. In the literature, there are studies conducted in other disease groups showing that aerobic exercise regulates tryptophan and serotonin levels and can produce positive results regarding these symptoms. This study was planned to evaluate the effect of high-intensity interval exercise training, which is an aerobic exercise form, whose benefits are frequently mentioned in recent publications, on both blood parameters and symptoms in fibromyalgia patients.
Detailed Description: Fibromyalgia is a chronic musculoskeletal disease of unknown etiology accompanied by symptoms such as pain, hyperalgesia, sleep disorders, fatigue and mood disorders. It has been suggested that a defect in the serotonergic system is involved in the pathophysiology of the disease. The serotonergic system has been associated with many symptoms such as anxiety, depression, sleep problems, fatigue and pain. In studies on fibromyalgia, it was reported that plasma tryptophan and serotonin levels decreased in this patient group and that serotonin levels were abnormal in the endogenous pain blocking pathways. Although conflicting results have been reported, it was stated that vitamin D levels were also low in this patient group. Aerobic exercise makes muscles use branched-chain amino acids, reducing the amount of amino acids that compete with tryptophan and increasing the chance of tryptophan to cross the blood-brain barrier. Therefore, it has the potential to increase serotonin in the brain. In particular, aerobic exercise appears to modulate hormone, neurotrophin and neurotransmitter levels, depending on factors such as genes, age and hormonal status. On the other hand, it is reported that some types of exercise increase the production of free radicals and cause oxidative stress. It has been suggested that oxidative stress may be associated with pain, which is one of the main symptoms in fibromyalgia patients by affecting nociceptors. Studies have shown that when aerobic exercises are applied regularly for a long time, lipid peroxidation level, which is an indicator of oxidative stress, decreases and antioxidant enzyme activity increases. Regularly applied aerobic exercise programs have been reported as a suitable form of exercise for this patient group. Recent studies have focused on high-intensity interval training. This type of exercise; It is performed as successive short and intermittent sessions of high-intensity activity with periods of low intensity or rest. High-intensity interval training are shorter than moderate aerobic workouts and produce the same or more positive effects than moderate exercise. It is also reported that high-intensity interval training application improves oxidative capacity, antioxidant defense and endothelial functions. Telerehabilitation practices refer to the use of telematics procedures using telephone, video and computer technologies instead of traditional face-to-face approaches. The therapist ensures that patient communication and follow-up are maintained by maintaining social distance. It has been stated in studies that telerehabilitation can be used to increase the quality of life, to provide socialization and to treat pain in patients with fibromyalgia. This study was designed to evaluate the effectiveness of high-intensity interval training upper extremity exercise training, which is a form of aerobic exercise, on these parameters, associated symptoms and oxidative stress markers in fibromyalgia patients with negative effects on serotonin, tryptophan, vitamin D and related parameters.
Study: NCT05502003
Study Brief:
Protocol Section: NCT05502003