Clinical trial NCT04195815: Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Fatigue Syndrome (CFS)
Myalgic Encephalomyelitis (ME)
Keywords: Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
ME/CFS
Physical activity
Activity armband
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 30 patients with ME/CFS according to Canadian Consensus Criteria (2003) with disease duration at least 2 years, of age 18-65 years

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of activity monitoring armband to assess physical activity in ME/CFS patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Olav Mella, MD, Prof
role: STUDY_DIRECTOR
References:
citation: 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.