Investigating the Effect of Swimming on Autonomic and Symptomatic Responses in Individuals With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Symptoms
研究概览
简要总结
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]
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For ME/CFS participants:
- •Be between the ages of 18-80
- •Meet the criteria of (ME/CFS). The diagnostic criteria for ME/CFS according to the primary Canadian Consensus Criteria are:
- •Fatigue (significant physical and mental fatigue that is new onset, unexplained, persistent or recurrent, and substantially reduces activity level),
- •Post-exertional malaise and/or post-exertional fatigue (general feeling of discomfort, weakness and/or fatigue, and potentially worsening associated symptoms, following physical or mental exertion; slow recovery which is usually longer than 24 hours),
- •Sleep dysfunction (unrefreshing sleep or disturbances in sleep quantity or rhythm), and
- •Pain (significant degree of muscle and/or joint pain, and/or significant headaches of new type, pattern or severity). This may include individuals with (but not limited to) Post-Viral Fatigue Syndrome, Long-Covid 19, Overtraining Syndrome (OTS), and/or co-occurring Postural Orthostatic Tachycardia Syndrome (POTS), Fibromyalgia, and/or Mast Cell Activation Syndrome (MCAS).
- •Experience some degree of post exertional malaise and have some degree of exercise intolerance upon physical exertion.
- •Must have been previously physically active and be able to swim
- •Must be considered moderate-to-mild CFS (not severe or very severe) with a FUNCAP27 score between 3.0-5.
- •Must be able to do some light physical activity and go to public places without causing post-exertional malaise.
排除标准
- •for all participants:
- •Individuals with cardiovascular, pulmonary, metabolic, renal, endocrine, autoimmune, neurological, inflammatory condition, infectious disease, or mental illness that makes exercise participation a risk will be excluded from the study.
- •Individuals who are pregnant will be excluded from the study.
- •Individuals with musculoskeletal injuries that prevent exercise participation will be excluded from the study
- •Inclusion Criteria for healthy controls:
- •Be between the ages of 18-80
- •Must be physically active and be able to swim.
研究组 & 干预措施
ME/CFS group
Individuals with ME/CFS and related conditions
干预措施: Swimming (Behavioral)
ME/CFS group
Individuals with ME/CFS and related conditions
干预措施: Cycling (Behavioral)
Control Group
Healthy age and sex matched controls
干预措施: Swimming (Behavioral)
Control Group
Healthy age and sex matched controls
干预措施: Cycling (Behavioral)
结局指标
主要结局
Symptoms
时间窗: From enrollment until minimally three days post final exercise session (11~15 days total)
Daily symptoms will be recorded in the Visible app each evening as part of the evening check-in. All available symptoms listed on the app will be evaluated (44 items, rated 0-3, with 0=none, and 3= severe). The total score will be the sum of all 44 items.
Heart Rate Variability
时间窗: From enrollment until minimially three days after one or both exercise sessions (11~15 days total)
HRV will be collected each morning upon waking, and in the seated-upright position, through the Visible application. This is assessed with lnRMSSD plotted on a 0-100 scale. Analyses will focus on changes in HRV from baseline to 24, 48, and 72 hours post-swim session compared to post-bike session.
次要结局
- Time to recovery(From enrollment to the post-exercise recovery periods from days ~9-11 and ~13-15.)
- Exercise Load(Exercise days ~8 and ~12.)
- Severity of ME/CFS(Baseline)
研究者
Alexandra Coates
Assistant Professor
Simon Fraser University