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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00961428
Other study ID # #5544
Secondary ID K23MH071285-02NI
Status Completed
Phase N/A
First received August 18, 2009
Last updated December 4, 2012
Start date December 2007
Est. completion date July 2011

Study information

Verified date December 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa.


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."


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary physical activity Physical activity before and after weight restoration No
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