Chronic Fatigue SyndromeNCT01908036
Use of a Monitor in ME/CFS
An observational study of Chronic Fatigue Syndrome, run by New York CFS Association at 1 site in United States.
Trial summary
The use of an activity monitor to determine increase or decrease of activity in patients suffering from chronic fatigue syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 CFS patients
Who may be able to join
- Fukuda and Canadian consensus criteria for the diagnosis of chronic fatigue syndrome
Who cannot join
- Acute disease and exclusion conditions in Fukuda criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Me/Cfs Center,860 Fifth Avenue
New York, New York, 10065
Derek enlander, MD, 212-794-2000, denlander@aol.com
derek enlander, MD
About this study
The use of an activity monitor to determine increase or decrease of activity in patients suffering from chronic fatigue syndrome.
Read the 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
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic fatigue syndrome, CFS, myalgic encephalomyelitis, M.E., activity monitor
- Medical subject headings
- Fatigue Syndrome, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
observation of activity level in CFS patients
observation of activity level in CFS patients using objective activity monitor
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York CFS Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908036
- Sponsor's protocol ID
- FITBIT2
- Status last verified
- Jul 2013
- First submitted
- 23 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Monitor in ME/CFS
- ClinicalTrials.gov ID
- NCT01908036
- Acronym / sponsor ID
- FITBIT2
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic fatigue syndrome, CFS, myalgic encephalomyelitis, M.E., activity monitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- New York CFS AssociationUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of an activity monitor to determine increase or decrease of activity in patients suffering from 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 CFS patients
Key inclusion criteria (1 listed)
- Fukuda and Canadian consensus criteria for the diagnosis of chronic fatigue syndrome
Key exclusion criteria (1 listed)
- Acute disease and exclusion conditions in Fukuda criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
observation of activity level in CFS patients
Time frame: 6 months
observation of activity level in CFS patients using objective activity monitor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by New York CFS Association at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact derek enlander, MD (2127942000, denlander@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
observation of activity level in CFS patients (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.