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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07454395
Brief Summary:
Individuals with ME/CFS experience profound exercise intolerance and post-exertional malaise. This remote (app-based) pilot study explores whether light, fully self-paced, swimming may be a tolerable form of movement for people with ME/CFS and related conditions, due to the distinct physiological effects of water immersion. The horizontal posture and hydrostatic pressure of water supports venous return and reduces orthostatic stress, while cool water exposure may influence autonomic and inflammatory responses. We are recruiting adults with mild-to-moderate ME/CFS and related conditions for this study examining short-term symptom and autonomic responses to gentle swimming. Participants will choose their own intensity and duration and may stop at any time. A light cycling session is available as an optional comparator for those who feel comfortable doing so. \[Note: this is not an exercise training or rehabilitation study, and participation is only intended for individuals who can tolerate some gentle activity and can be in public spaces without triggering post-exertional malaise. You should be comfortable with swimming, but flotation or other assistive devices are welcome\]
Detailed Description:
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating multisystem disorder characterized by extreme fatigue, sleep dysfunction, pain, and post-exertional malaise and/or post-exertional fatigue, and is accompanied by orthostatic intolerance, and neuroendocrine and immune manifestations. The defining feature of ME/CFS is the delayed onset (\~12-48 h) exacerbation of symptoms following physical, cognitive, orthostatic, and even emotional exertion, termed post-exertional malaise (PEM). As such, despite the known benefits of exercise for improving function in most disease states including other multisystem inflammatory disorders like sepsis, exercising with ME/CFS is generally contraindicated to avoid a worsening of the condition.
It has been demonstrated that neurovascular dysregulation underlies much of the exercise intolerance in ME/CFS. When neurovascular function is normalized with pharmacologic cholinergic stimulation in ME/CFS patients performing upright cycling exercise, cardiac output, right atrial pressures, and maximal oxygen consumption are improved, possibly preventing post-exertional malaise. Water immersion can also be used to normalize cardiac output and right atrial pressures, as the prone/supine postures and hydrostatic pressure of the water act to passively encourage venous return. Furthermore, the human dive reflex (when the face is submerged in cool water) increases parasympathetic activation to the heart, slowing down heart rate. There is also evidence of anti-inflammatory effects of swimming in patients with cardiovascular, neurological, and rheumatological diseases, which could also improve inflammation in ME/CFS patients. The purpose of this study is to determine whether light-to-moderate swimming may be a more tolerable form of movement for individuals with ME/CFS.
Study:
NCT07454395
Study Brief:
Protocol Section:
NCT07454395