Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
A Pilot Study for Continuous Monitoring of Physical Activity Using Activity Armbands for 6 Months: Assessment of Feasibility and Comparison to Self-reported Questionnaires
1 other identifier
observational
27
1 country
1
Brief Summary
The investigators will assess the feasibility of activity monitoring armbands for continuous measurement of physical activity level in ME/CFS patients, during 6 months follow-up. The main purpose is to assess if continuous measurement of activity level may be incorporated in outcome measures in future clinical interventional trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedStudy Start
First participant enrolled
March 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2020
CompletedMay 11, 2021
December 1, 2019
8 months
December 10, 2019
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of activity monitoring armband to assess physical activity in ME/CFS patients
Feasibility of activity monitoring armbands to assess level of physical activity in ME/CFS patients, with comparison of activity data to self-reported questionnaires for quality of life (SF-36 ver.2) and for ME/CFS symptoms (DSQ-SF)
6 months
Eligibility Criteria
Approximately 30 patients with ME/CFS according to Canadian Consensus Criteria (2003) with disease duration at least 2 years, of age 18-65 years
You may qualify if:
- Patients wit ME/CFS according to Canadian Consensus Criteria (2003)
- ME/CFS disease duration at least 2 years
- Mild, Mild/moderate, Moderate, Moderate/Severe and Severe ME/CFS may be included
- Signed informed consent
You may not qualify if:
- Patients with fatigue, who do not meet the diagnostic "Canadian" criteria (2003) for ME/CFS
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haukeland University Hospital
Bergen, N-5020, Norway
Related Publications (1)
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.
PMID: 36121803DERIVED
Biospecimen
Blood samples (serum, plasma, full blood) will be collected at baseline
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Olav Mella, MD, Prof
Haukeland University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2019
First Posted
December 12, 2019
Study Start
March 11, 2020
Primary Completion
November 20, 2020
Study Completion
November 20, 2020
Last Updated
May 11, 2021
Record last verified: 2019-12