We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of a Monitor in 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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01908036
Recruitment Status : Unknown
Verified July 2013 by New York CFS Association.
Recruitment status was:  Recruiting
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
New York CFS Association

Brief Summary:
The use of an activity monitor to determine increase or decrease of activity in patients suffering from chronic fatigue syndrome.

Condition or disease
Chronic Fatigue Syndrome

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

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2013
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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



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.


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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Acute disease and exclusion conditions in Fukuda criteria


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): NCT01908036


Contacts
Contact: derek enlander, MD 2127942000 denlander@aol.com

Locations
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    denlander@aol.com   
Principal Investigator: derek enlander, MD         
Sponsors and Collaborators
New York CFS Association

Responsible Party: New York CFS Association
ClinicalTrials.gov Identifier: NCT01908036     History of Changes
Other Study ID Numbers: FITBIT2
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases