Use of a Monitor in ME/CFS

NCT ID: NCT01908036

Last Updated: 2013-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Chronic Fatigue Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Acute disease and exclusion conditions in Fukuda criteria
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York CFS Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Me/Cfs Center,860 Fifth Avenue

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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derek enlander, MD

Role: CONTACT

2127942000

Facility Contacts

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Derek enlander, MD

Role: primary

212-794-2000

Other Identifiers

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FITBIT2

Identifier Type: -

Identifier Source: org_study_id

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