Use of a Monitor in ME/CFS

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by New York CFS Association
Sponsor:
Information provided by (Responsible Party):
New York CFS Association
ClinicalTrials.gov Identifier:
NCT01908036
First received: July 23, 2013
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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


Condition
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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

  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 ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: New York CFS Association
ClinicalTrials.gov Identifier: NCT01908036     History of Changes
Other Study ID Numbers: FITBIT2
Study First Received: July 23, 2013
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014