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

Completed

• Conditions: Myalgic Encephalomyelitis (ME); Chronic Fatigue Syndrome (CFS)

• Registration Number: NCT04195815
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Study Start: 2020-03-11
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of activity monitoring armband to assess physical activity in ME/CFS patients	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)

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway