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

Chronic Fatigue Syndrome (CFS) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04195815
• Other study ID #: 28780
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2019
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months