Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

N/ACompletedNCT04195815

Haukeland University Hospital27 enrolled

Overview

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.

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

Enrollment

Conditions

Chronic Fatigue Syndrome (CFS)Myalgic Encephalomyelitis (ME)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Haukeland University Hospital

Bergen, Norway

Outcomes

Primary Outcomes

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)

Time frame: 6 months

Data from ClinicalTrials.gov

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