NCT04195815

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Fatigue Syndrome (CFS)
• Myalgic Encephalomyelitis (ME)

Timeline

• Start date: 2020-03-11
• Primary completion: 2020-11-20
• Completion: 2020-11-20
• First posted: 2019-12-12
• Last updated: 2021-05-11

Locations

1 site across 1 country: Norway