- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454395
Is Swimming a More Tolerable Form of Movement for Individuals With Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome? (ME/CFS)
Investigating the Effect of Swimming on Autonomic and Symptomatic Responses in Individuals With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Burnaby, British Columbia, Canada, V5A 1S6
- Simon Fraser University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria 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: 1. Fatigue (significant physical and mental fatigue that is new onset, unexplained, persistent or recurrent, and substantially reduces activity level), 2. 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), 3. Sleep dysfunction (unrefreshing sleep or disturbances in sleep quantity or rhythm), and 4. 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 3.0-5.8.
- Must be able to do some light physical activity and go to public places without causing post-exertional malaise.
Exclusion Criteria 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ME/CFS group
Individuals with ME/CFS and related conditions
|
Following a week of baseline HRV and symptoms tracking, all participants will be asked to perform a light swimming session.
This session should be at a self-selected intensity and duration, however it should always be performed at an intensity that is under a rating of perceived exertion of 5/10 (easy to moderate at most).
Recommended duration is ~15-30 min.
Participants may use flotation or assistive devices as they wish.
Cool water is recommended.
After a minimum of three days of recovery following swimming, and once the visible application indicates a stable recovery score of at least 4/5 (and the participant feels okay), they may optionally complete a cycling session on a stationary bike.
This biking session will also be at a self-selected duration and intensity (effort <5/10), which does not need to match the first session.
If participants feel that they are unable to complete the biking exercise session, they can still participate in the study and only complete the swimming.
If they believe that it would exacerbate symptoms and cause harm, they should not do the biking.
|
|
Active Comparator: Control Group
Healthy age and sex matched controls
|
Following a week of baseline HRV and symptoms tracking, all participants will be asked to perform a light swimming session.
This session should be at a self-selected intensity and duration, however it should always be performed at an intensity that is under a rating of perceived exertion of 5/10 (easy to moderate at most).
Recommended duration is ~15-30 min.
Participants may use flotation or assistive devices as they wish.
Cool water is recommended.
After a minimum of three days of recovery following swimming, and once the visible application indicates a stable recovery score of at least 4/5 (and the participant feels okay), they may optionally complete a cycling session on a stationary bike.
This biking session will also be at a self-selected duration and intensity (effort <5/10), which does not need to match the first session.
If participants feel that they are unable to complete the biking exercise session, they can still participate in the study and only complete the swimming.
If they believe that it would exacerbate symptoms and cause harm, they should not do the biking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms
Time Frame: 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.
|
From enrollment until minimally three days post final exercise session (11~15 days total)
|
|
Heart Rate Variability
Time Frame: 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.
|
From enrollment until minimially three days after one or both exercise sessions (11~15 days total)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to recovery
Time Frame: From enrollment to the post-exercise recovery periods from days ~9-11 and ~13-15.
|
The time to recovery from each exercise session will be assessed.
This will be defined as the number of days it takes for the readiness scores to reach at least a 4 out of 5 on the Visible App.
|
From enrollment to the post-exercise recovery periods from days ~9-11 and ~13-15.
|
|
Exercise Load
Time Frame: Exercise days ~8 and ~12.
|
The intensity and duration of the exercise sessions will be determined as the duration of the exercise in minutes multiplied by the rating of perceived exertion for the session (sRPE) on a Borg 0-10 scale.
|
Exercise days ~8 and ~12.
|
|
Severity of ME/CFS
Time Frame: Baseline
|
The functional capacity 27 scale will be used to assess the functional severity of each participant's condition.
The scale has 27 statements, that are ranked from on a likert scale of 0-6, with 0 being "unable to perform that activity", and 6 being "unproblematic - does not affect other activities."
The average score from all 27 statements is used as the overall score.
Only participants with a score ≥3.0 and <5.8 will be included in the study (representing mild-to-moderate ME/CFS).
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandra Coates, PhD, Biomedical Physiology and Kinesiology, Simon Fraser University
Publications and helpful links
General Publications
- Arron HE, Marsh BD, Kell DB, Khan MA, Jaeger BR, Pretorius E. Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: the biology of a neglected disease. Front Immunol. 2024 Jun 3;15:1386607. doi: 10.3389/fimmu.2024.1386607. eCollection 2024.
- Kooshki M, Rezeai-Farimani R, Moradpour A, Baradaran Rahimi V, Askari VR. How Swimming Modulates Inflammatory Pathways in Pain, Neurodegenerative, and Metabolic Disorders. Brain Sci. 2025 Oct 18;15(10):1121. doi: 10.3390/brainsci15101121.
- Sommerfelt K, Schei T, Seton KA, Carding SR. Assessing Functional Capacity in Myalgic Encephalopathy/Chronic Fatigue Syndrome: A Patient-Informed Questionnaire. J Clin Med. 2024 Jun 14;13(12):3486. doi: 10.3390/jcm13123486.
- Sawyer A, Preston R, Leeming H, Martin-Fuller L, Proal A, Putrino D. Wearable technology in the management of complex chronic illness: preliminary survey results on self-reported outcomes. Front Digit Health. 2025 Oct 8;7:1662255. doi: 10.3389/fdgth.2025.1662255. eCollection 2025.
- Joseph P, Pari R, Miller S, Warren A, Stovall MC, Squires J, Chang CJ, Xiao W, Waxman AB, Systrom DM. Neurovascular Dysregulation and Acute Exercise Intolerance in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Randomized, Placebo-Controlled Trial of Pyridostigmine. Chest. 2022 Nov;162(5):1116-1126. doi: 10.1016/j.chest.2022.04.146. Epub 2022 May 6.
- Vernon SD, Funk S, Bateman L, Stoddard GJ, Hammer S, Sullivan K, Bell J, Abbaszadeh S, Lipkin WI, Komaroff AL. Orthostatic Challenge Causes Distinctive Symptomatic, Hemodynamic and Cognitive Responses in Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Front Med (Lausanne). 2022 Jun 23;9:917019. doi: 10.3389/fmed.2022.917019. eCollection 2022.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neuroinflammatory Diseases
- Post-Infectious Disorders
- COVID-19
- Mast Cell Activation Disorders
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Pathologic Processes
- Encephalomyelitis
- Neuromuscular Diseases
- Chronic Disease
- Disease Attributes
- Rheumatic Diseases
- Immune System Diseases
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Primary Dysautonomias
- Autonomic Nervous System Diseases
- Orthostatic Intolerance
- Fatigue
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Post-Acute COVID-19 Syndrome
- Mast Cell Activation Syndrome
- Fatigue Syndrome, Chronic
- Fibromyalgia
- Postural Orthostatic Tachycardia Syndrome
- Overtraining Syndrome
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
- Locomotion
- Swimming
Other Study ID Numbers
- 30003523
- n2cx3 (Registry Identifier: OSF Registries)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
Selcuk UniversityNot yet recruiting
-
Fundació Institut de Recerca de l'Hospital de la...CompletedFibromyalgia (FM)Spain
-
Istanbul Gelisim UniversityBahçeşehir UniversityCompleted
-
Gazi UniversityCompletedFibromyalgia SyndromeTurkey (Türkiye)
-
University of UtahRecruitingFibromyalgia (FM)United States
-
María Catalina Osuna PérezActive, not recruitingFibromyalgia SyndromeSpain
-
Ionclinics & Deionic SLHospital Clínico Universitario de ValenciaNot yet recruitingFibromyalgia (FM)Spain
-
Ain Shams UniversityRecruiting
-
Istanbul UniversityCompletedFibromyalgia | Fibromyalgia Syndrome | Fibromyalgia (FM)Turkey (Türkiye)
Clinical Trials on Swimming
-
University of Rouen NormandieFrench Institute of Sport (INSEP); French swimming federation (FFN); French federation...Enrolling by invitationOxygen Consumption | Swimming | Coordination Lack | Lactic Acid Blood IncreasedFrance
-
Ottawa Hospital Research InstituteUniversity of Ottawa; Bruyere Research InstituteRecruitingPain, Postoperative | Lymphedema | Seroma | Pain, ChestCanada
-
Józef Piłsudski University of Physical EducationCompletedSwimming Kinematics | Front Crawl Technique | Swimming TechniquePoland
-
Pusan National UniversityUniversity of Nebraska; Marymount University; Dong-Eui UniversityCompletedHypertension | Menopause
-
University School of Physical Education, Krakow...Active, not recruiting
-
Wroclaw Medical UniversityCompletedCovid19 | Hypothermia | SARS-CoV Infection | Hypothermia Due to Cold Environment | Resistance, DiseasePoland
-
National University of Ireland, Galway, IrelandSuspended
-
Federal University of VicosaActive, not recruitingPhysical Fitness | Youth | Swimming KinematicsColombia
-
Devon Partnership NHS TrustCompleted
-
Benha UniversityRecruitingChildren | Muscle Spasticity | Spastic Cerebral Palsy | Motor Function | Diving | AquaticEgypt