Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
NCT ID: NCT04195815
Last Updated: 2021-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
27 participants
OBSERVATIONAL
2020-03-11
2020-11-20
Brief Summary
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Detailed Description
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The investigators will assess which physical activity parameters that best seem to reflect the participant's own perception of activity level, such as mean number of steps per 24 hours.
The investigators will assess the agreement between continuous activity measurements by activity armbands, and self-reported questionnaires for health-related quality of life (SF-36 ver.2) and for ME/CFS symptoms (DSQ-SF).
The investigators will assess the agreement between activity monitoring by armbands, and previously validated activity monitoring bracelets for 5-7 consecutive days, at baseline, at 3 months and at 6 months follow-up.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ME/CFS disease duration at least 2 years
* Mild, Mild/moderate, Moderate, Moderate/Severe and Severe ME/CFS may be included
* Signed informed consent
Exclusion Criteria
* ME/CFS disease duration \< 24 months
* Patients where the diagnostic workup uncovers other pathology as possible cause of symptoms
* Serious endogenous depression
* Lack of ability to complete the study including follow-up
18 Years
65 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Olav Mella, MD, Prof
Role: STUDY_DIRECTOR
Haukeland University Hospital
Locations
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Haukeland University Hospital
Bergen, , Norway
Countries
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References
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Rekeland IG, Sorland K, Bruland O, Risa K, Alme K, Dahl O, Tronstad KJ, Mella O, Fluge O. Activity monitoring and patient-reported outcome measures in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients. PLoS One. 2022 Sep 19;17(9):e0274472. doi: 10.1371/journal.pone.0274472. eCollection 2022.
Other Identifiers
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28780
Identifier Type: -
Identifier Source: org_study_id
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