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SuspendedNCT07454395ME/CFSUpdated Mar 30, 2026

Is Swimming a More Tolerable Form of Movement for Individuals With Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome?

An interventional study of Swimming and Cycling in ME/CFS, Long COVID and Post- COVID-19 Syndrome, sponsored by Simon Fraser University. Suspended at 1 site in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Simon Fraser University · Not applicable, Interventional, and Supportive care

Why this study was suspended
The research ethics board suspended the study to investigate a complaint from a community member who is not enrolled in the study. This community member is worried about exercise in this population.There have been no complaints from participants.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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]

Read the 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.

02

Conditions studied

  • ME/CFS
  • Long COVID
  • Post- COVID-19 Syndrome
  • POTS - Postural Orthostatic Tachycardia Syndrome
  • Fibromyalgia
  • Overtraining Syndrome
  • Post-Viral Fatigue Syndrome
  • Mast Cell Activation Syndrome

Keywords

  • swimming
  • ME/CFS
  • HRV
  • Visible App
  • long-covid
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    ME/CFS group

    Individuals with ME/CFS and related conditions

    Behavioral: Swimming · Behavioral: Cycling

  • Active comparator
    Control Group

    Healthy age and sex matched controls

    Behavioral: Swimming · Behavioral: Cycling

Interventions

  • BehavioralSwimming

    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.

  • BehavioralCycling

    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.

05

What researchers measure

Primary outcomes

  1. Symptoms

    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.

    Time frame: From enrollment until minimally three days post final exercise session (11~15 days total)

  2. Heart Rate Variability

    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.

    Time frame: From enrollment until minimially three days after one or both exercise sessions (11~15 days total)

Secondary outcomes

  1. Time to recovery

    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.

    Time frame: From enrollment to the post-exercise recovery periods from days ~9-11 and ~13-15.

  2. Exercise Load

    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.

    Time frame: Exercise days ~8 and ~12.

  3. Severity of ME/CFS

    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).

    Time frame: Baseline

06

Study locations

1 site
  • Simon Fraser University
    Burnaby, British Columbia V5A 1S6, Canada
07

References and documents

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. PubMed 38887284 ↗
  • 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. PubMed 41154214 ↗
  • 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. PubMed 38930014 ↗
  • 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. PubMed 41132394 ↗
  • 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. PubMed 35847821 ↗
  • 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. PubMed 35526605 ↗

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07454395
Lead sponsor
Simon Fraser University
Responsible party
Alexandra Coates (Assistant Professor, Simon Fraser University) — Principal investigator
First posted
Mar 6, 2026
Start date
Feb 20, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Mar 30, 2026

Study contacts

Alexandra Coates, PhD
principal investigator · Biomedical Physiology and Kinesiology, Simon Fraser University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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