Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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|ClinicalTrials.gov Identifier: NCT04195815|
Recruitment Status : Not yet recruiting
First Posted : December 12, 2019
Last Update Posted : December 16, 2019
|Condition or disease|
|Chronic Fatigue Syndrome (CFS) Myalgic Encephalomyelitis (ME)|
The purpose is to assess feasibility of activity monitoring armbands for continuous measurement of physical activity level in patents with Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS), during 6 months follow-up.
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||A Pilot Study for Continuous Monitoring of Physical Activity Using Activity Armbands for 6 Months: Assessment of Feasibility and Comparison to Self-reported Questionnaires|
|Estimated Study Start Date :||December 10, 2019|
|Estimated Primary Completion Date :||December 10, 2020|
|Estimated Study Completion Date :||December 10, 2021|
- Feasibility of activity monitoring armband to assess physical activity in ME/CFS patients [ Time Frame: 6 months ]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)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195815
|Contact: Øystein Fluge, MD, Prof||47 firstname.lastname@example.org|
|Contact: Kari Sørland, RN||+47 email@example.com|
|Study Director:||Olav Mella, MD, Prof||Haukeland University Hospital|