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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04195815

Enrollment

Registered

2019-12-12

Start date

2020-03-11

Completion date

2020-11-20

Last updated

2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, ME/CFS, Physical activity, Activity armband

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Norway

Outcome results