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Use of a Monitor in ME/CFS

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by New York CFS Association.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
New York CFS Association Identifier:
First received: July 23, 2013
Last updated: July 24, 2013
Last verified: July 2013
The use of an activity monitor to determine increase or decrease of activity in patients suffering from chronic fatigue syndrome.

Chronic Fatigue Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by New York CFS Association:

Primary Outcome Measures:
  • observation of activity level in CFS patients [ Time Frame: 6 months ]
    observation of activity level in CFS patients using objective activity monitor

Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:
A cohort of 50 patients suffering from chronic fatigue syndrome will be given an informed release form. Have a signed the informed release they will be given a Fitbit activity monitor. These monitors will be evaluated on a weekly interval by computer interface. The activity will be calculated to determine the online of activity and whether there is increase or decrease in activity during the time of the study. The study is an observational rather than an interventional study. There is no invasion or intervention in the patient's normal activities

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
50 CFS patients

Inclusion Criteria:

Fukuda and Canadian consensus criteria for the diagnosis of chronic fatigue syndrome

Exclusion Criteria:

Acute disease and exclusion conditions in Fukuda criteria

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01908036

Contact: derek enlander, MD 2127942000

United States, New York
Me/Cfs Center,860 Fifth Avenue Recruiting
New York, New York, United States, 10065
Contact: Derek enlander, MD    212-794-2000   
Principal Investigator: derek enlander, MD         
Sponsors and Collaborators
New York CFS Association
  More Information

Responsible Party: New York CFS Association Identifier: NCT01908036     History of Changes
Other Study ID Numbers: FITBIT2
Study First Received: July 23, 2013
Last Updated: July 24, 2013

Keywords provided by New York CFS Association:
Chronic fatigue syndrome
myalgic encephalomyelitis
activity monitor

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases processed this record on August 16, 2017