- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961428
Motivation to Exercise in People With Anorexia Nervosa
December 4, 2012 updated by: New York State Psychiatric Institute
Behavioral Assessment of the Reinforcing Effects of Exercise in Patients With Anorexia Nervosa
The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa.
Study Overview
Status
Completed
Conditions
Detailed Description
A laboratory paradigm that uses a progressive ratio computerized work task will be used to determine the reinforcing value of exercise in hospitalized patients with AN, both before and after weight gain.
In addition, we will examine the relationship between the reinforcing value of exercise and free-living physical activity in this population.
We will also examine the relationship between the reinforcing value of exercise and measures of depression, anxiety, and cortisol, which we have found in previous studies to be associated with other measures of physical activity and exercise motivation.
In order to determine whether physical activity in women with AN differs from that of non-eating disordered women, we will extend studies of physical activity to free-living control participants.
All adult patients and controls will undergo body composition assessment once to measure the association between physical activity and percent body fat.
Finally, to determine the impact of exercise reinforcement and physical activity on outcome in women with AN, we will conduct follow-up assessments in all patient participants for one year after discharge from the inpatient treatment unit."
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Participants will be patients with anorexia nervosa on the inpatient unit at New York State Psychiatric Institute
Description
Inclusion Criteria:
- DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea)
- Female
- Age 18-45
- Medically Stable for exercise participation
- At a minimum of 75% Ideal Body Weight
Exclusion Criteria:
- Significant or current past medical illness including diabetes mellitis and heart disease
- Current or lifetime history or schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
- Current suicidal ideation or recent suicidal behavior (within past 3 months)
- Drug or alcohol abuse in last 6 months
- Taking psychotropic medication
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
physical activity
Time Frame: Physical activity before and after weight restoration
|
Physical activity before and after weight restoration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: B. Timothy Walsh, MD, NYSPI
- Principal Investigator: Evelyn Attia, MD, NYSPI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
August 18, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
Study Record Updates
Last Update Posted (Estimate)
December 5, 2012
Last Update Submitted That Met QC Criteria
December 4, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #5544
- DATR AK-TNAI1
- K23MH071285-02 (U.S. NIH Grant/Contract)
- NIMH K23 071285 (Other Grant/Funding Number: NIMH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.