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NCT01908036 Clinical Trial

Use of a Monitor in ME/CFS

Chronic Fatigue Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01908036
Other study ID # FITBIT2
Secondary ID
Status Recruiting
Phase N/A
First received July 23, 2013
Last updated July 24, 2013
Start date July 2013
Est. completion date December 2013

Study information
Verified date July 2013
Source New York CFS Association
Contact derek enlander, MD
Phone 2127942000
Email denlander@aol.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Acute disease and exclusion conditions in Fukuda criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Me/Cfs Center,860 Fifth Avenue New York New York

Sponsors (1)
Lead Sponsor Collaborator
New York CFS Association

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary observation of activity level in CFS patients observation of activity level in CFS patients using objective activity monitor 6 months Yes
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