Status:
COMPLETED
Response to Acute Exercise in Eating Disorders
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Eating Disorders
Eligibility:
FEMALE
16-25 years
Phase:
NA
Brief Summary
Individuals with eating disorders (ED) represent a high-priority clinical population, with among the highest mortality rates of any psychiatric disorder, and driven exercise (DEx) is a symptom evidenc...
Detailed Description
Eating disorders (EDs) are among the deadliest of all psychiatric disorders. However, first-line treatments for EDs are effective for only roughly 40% of adolescent patients. One barrier to treatment ...
Eligibility Criteria
Inclusion
- Aged 16-25
- ED participants must meet full criteria for DSM-5 restrictive-spectrum eating disorders characterized by weight and shape concern, I.e., anorexia nervosa (AN); mild, moderate, or in partial remission), atypical AN, and OSFED -AN type only)
- ED participants must be medically stable, and suitable for outpatient treatment
- Biological Females, Assigned Female at birth
- English Speaking
Exclusion
- Those with a medical condition that precludes exercise (e.g., severe asthma) will be excluded for any contraindications
- Biological Males, Assigned Male at birth
- BMI less than 16 (over 18 years) or less than 75% expected body weight (under 18 years)
- Reported intake on Eating Disorder Examination \<1000kcal daily
- Current purging \>1x per day
- Current regular episodes of objective binge eating (\>1x/wk)
- Current self-report of loss-of control eating per the Eating Disorders Examination Interview
- ED related hospitalization, partial hospitalization, or residential treatment in the past month
- Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease).
- Major medical disorders (e.g., cancer, AIDS)
- Physical discomfort or difficulty with blood draws
- Psychotic disorders
- Intellectual disabilities
- Developmental disorders
- Active substance use disorder
- Current suicidal risk per the Ask Suicide Screening Questionnaire
- Pregnancy
- Psychiatric medications that have not been stable for at least 4 weeks
- Acute sedatives / pain killers (e.g., benzodiazepines, opioids) and prescription stimulants (e.g., methylphenidate, amphetamines) are not permitted for the full day prior to the laboratory session. The noted short-term medication holds only apply to subjects taking the noted medications in cases used to treat ADHD or other psychiatric conditions
- Resting heart rate \<50 beats per minute (assessed at screening visit)
- Low blood pressure (\<90/60), (assessed at screening visit)
- Daily cannabis use
- History of light headedness or fainting during blood draws or physical activity
- History of chest pain during physical activity
- Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., COPD, diabetes, hypertension) that are not currently addressed via medication or lifestyle change.
- Physical disabilities that prohibit task performance (such as blindness or deafness)
- Any other condition that the investigator believes might put the participant at risk for negative outcomes
- Individuals with a restrictive eating disorder presentation that does not include weight and shape concern (ARFID) or that has primary binge eating (bulimia nervosa)
- Indication of health risk associated with exercise on the Physical Activity Readiness Questionnaire
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06213883
Start Date
November 2 2023
End Date
July 31 2025
Last Update
August 6 2025
Active Locations (2)
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1
University of California San Francisco
San Francisco, California, United States, 94158
2
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53719