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

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.

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Key information

Conditions

Chronic Fatigue Syndrome (CFS) Behavior Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Motor Activity Muscular Diseases Musculoskeletal Diseases Myalgic Encephalomyelitis (ME) Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, N-5020, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study 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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Dec 12, 2019
Registry last updated: May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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