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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195815
Recruitment Status : Not yet recruiting
First Posted : December 12, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Chronic Fatigue Syndrome (CFS) Myalgic Encephalomyelitis (ME)

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Estimated Study Start Date : December 10, 2019
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Biospecimen Retention:   Samples With DNA
Blood samples (serum, plasma, full blood) will be collected at baseline


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Approximately 30 patients with ME/CFS according to Canadian Consensus Criteria (2003) with disease duration at least 2 years, of age 18-65 years
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195815


Contacts
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Contact: Øystein Fluge, MD, Prof 47 55973587 oystein.fluge@helse-bergen.no
Contact: Kari Sørland, RN +47 55970439 kari.sorland@helse-bergen.no

Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Study Director: Olav Mella, MD, Prof Haukeland University Hospital
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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT04195815    
Other Study ID Numbers: 28780
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haukeland University Hospital:
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
ME/CFS
Physical activity
Activity armband
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Myalgia
Encephalomyelitis
Syndrome
Fatigue
Disease
Pathologic Processes
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Central Nervous System Infections
Musculoskeletal Pain
Pain
Neurologic Manifestations