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. \[Note: this is not an exercise training or rehabilitation study, and participation is only intended for individuals who can tolerate some gentle activity and can be in public spaces without triggering post-exertional malaise. You should be comfortable with swimming, but flotation or other assistive devices are welcome\]

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Feb 2026Jun 2027

Study Start

First participant enrolled

February 20, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

February 25, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

swimmingME/CFSHRVVisible Applong-covid

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

ME/CFS group

EXPERIMENTAL

Individuals with ME/CFS and related conditions

Behavioral: SwimmingBehavioral: Cycling

Control Group

ACTIVE COMPARATOR

Healthy age and sex matched controls

Behavioral: SwimmingBehavioral: Cycling

Interventions

SwimmingBEHAVIORAL

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.

Control GroupME/CFS group
CyclingBEHAVIORAL

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.

Control GroupME/CFS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Be between the ages of 18-80
  • Must be physically active and be able to swim.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simon Fraser University

Burnaby, British Columbia, V5A 1S6, Canada

Location

Related Publications (6)

  • 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.

    PMID: 38887284BACKGROUND
  • 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.

    PMID: 41154214BACKGROUND
  • 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.

    PMID: 38930014BACKGROUND
  • 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.

    PMID: 41132394BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 35526605BACKGROUND

Related Links

MeSH Terms

Conditions

Fatigue Syndrome, ChronicPost-Acute COVID-19 SyndromePostural Orthostatic Tachycardia SyndromeFibromyalgiaOvertraining SyndromeMast Cell Activation Syndrome

Interventions

Swimming

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCOVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesRheumatic DiseasesFatigueSigns and SymptomsMast Cell Activation DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Alexandra Coates, PhD

    Biomedical Physiology and Kinesiology, Simon Fraser University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: This is non-randomized cross-over design. A healthy age and sex matched control group will perform the same intervention to understand the healthy response to the interventions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 6, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations