Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:12 AM
Study NCT ID:
NCT07454395
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Swimming a More Tolerable Form of Movement for Individuals With Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D054972', 'term': 'Postural Orthostatic Tachycardia Syndrome'}, {'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D000095027', 'term': 'Overtraining Syndrome'}, {'id': 'D000090267', 'term': 'Mast Cell Activation Syndrome'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D000090362', 'term': 'Mast Cell Activation Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013550', 'term': 'Swimming'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms', 'timeFrame': 'From enrollment until minimally three days post final exercise session (11~15 days total)', 'description': '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.'}, {'measure': 'Heart Rate Variability', 'timeFrame': 'From enrollment until minimially three days after one or both exercise sessions (11~15 days total)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Time to recovery', 'timeFrame': 'From enrollment to the post-exercise recovery periods from days ~9-11 and ~13-15.', 'description': '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.'}, {'measure': 'Exercise Load', 'timeFrame': 'Exercise days ~8 and ~12.', 'description': '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.'}, {'measure': 'Severity of ME/CFS', 'timeFrame': 'Baseline', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['swimming', 'ME/CFS', 'HRV', 'Visible App', 'long-covid'], 'conditions': ['ME/CFS', 'Long COVID', 'Post- COVID-19 Syndrome', 'POTS - Postural Orthostatic Tachycardia Syndrome', 'Fibromyalgia', 'Overtraining Syndrome', 'Post-Viral Fatigue Syndrome', 'Mast Cell Activation Syndrome']}, 'referencesModule': {'references': [{'pmid': '38887284', 'type': 'BACKGROUND', 'citation': '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': '41154214', 'type': 'BACKGROUND', 'citation': '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': '38930014', 'type': 'BACKGROUND', 'citation': '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': '41132394', 'type': 'BACKGROUND', 'citation': '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': '35847821', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35526605', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.exercisephysiologyandperformancelab.com/get-involved', 'label': 'Lab website'}]}, 'descriptionModule': {'briefSummary': '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\\]', 'detailedDescription': '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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria For ME/CFS participants:\n\n* Be between the ages of 18-80\n* 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).\n* Experience some degree of post exertional malaise and have some degree of exercise intolerance upon physical exertion.\n* Must have been previously physically active and be able to swim\n* Must be considered moderate-to-mild CFS (not severe or very severe) with a FUNCAP27 score between 3.0-5.8.\n* Must be able to do some light physical activity and go to public places without causing post-exertional malaise.\n\nExclusion Criteria for all participants:\n\n* 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.\n* Individuals who are pregnant will be excluded from the study.\n* Individuals with musculoskeletal injuries that prevent exercise participation will be excluded from the study\n\nInclusion Criteria for healthy controls:\n\n* Be between the ages of 18-80\n* Must be physically active and be able to swim.'}, 'identificationModule': {'nctId': 'NCT07454395', 'acronym': 'ME/CFS', 'briefTitle': 'Is Swimming a More Tolerable Form of Movement for Individuals With Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome?', 'organization': {'class': 'OTHER', 'fullName': 'Simon Fraser University'}, 'officialTitle': 'Investigating the Effect of Swimming on Autonomic and Symptomatic Responses in Individuals With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome', 'orgStudyIdInfo': {'id': '30003523'}, 'secondaryIdInfos': [{'id': 'n2cx3', 'type': 'REGISTRY', 'domain': 'OSF Registries'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ME/CFS group', 'description': 'Individuals with ME/CFS and related conditions', 'interventionNames': ['Behavioral: Swimming', 'Behavioral: Cycling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Healthy age and sex matched controls', 'interventionNames': ['Behavioral: Swimming', 'Behavioral: Cycling']}], 'interventions': [{'name': 'Swimming', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control Group', 'ME/CFS group']}, {'name': 'Cycling', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Control Group', 'ME/CFS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5A 1S6', 'city': 'Burnaby', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Alicia Ranahan, BSc', 'role': 'CONTACT', 'email': 'amr10@sfu.ca', 'phone': '1-778-782-4589'}, {'name': 'Alicia Ranahan, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra Coates, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Simon Fraser University', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}], 'centralContacts': [{'name': 'Alicia Ranahan, BSc', 'role': 'CONTACT', 'email': 'amr10@sfu.ca', 'phone': '1-778-782-4589'}], 'overallOfficials': [{'name': 'Alexandra Coates, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biomedical Physiology and Kinesiology, Simon Fraser University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simon Fraser University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alexandra Coates', 'investigatorAffiliation': 'Simon Fraser University'}}}}