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COMPLETED

NCT06213883

Response to Acute Exercise in Eating Disorders

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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 evidenced in up to 80% of those with EDs that increases impairment and negatively impacts treatment outcome. This study will develop tasks to characterize cognitive, affective, and biological response to exercise among adolescent and young adult females with EDs and determine whether acute exercise response associates with free-living activity and DEx. This R21 project will provide foundational data to guide research and development of treatments that are more precisely targeted to the symptom of driven exercise and to ultimately improve clinical outcomes associated with EDs.

Official title: Characterizing Acute Exercise Response in Restrictive Eating Disorders

Key Details

Gender

FEMALE

Age Range

16 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-11-02

Completion Date

2025-07-31

Last Updated

2026-08-25

Healthy Volunteers

Yes

Conditions

Eating Disorders

Interventions

OTHER

Biobehavioral Response to in-lab exposure to physical activity

ED severity, biological and affective markers of physical activity response, and both exercise-specific and general positive (reward) and negative (avoidance/escape) valence sensitivities associate with physical activity will be comprehensively examined. During three different days, participants will: * A: Complete 2 different tasks, a reward task (prescribed rest condition) with self-report measures and two blood draws before and after completing the 30 minute rest condition, and a threat task (self-paced exercise condition) with self-report measures, a food challenge (to drink a milkshake) and 30 minutes of exercise. * B: Complete a reward task (prescribe exercise condition) where participants will earn points for exercise and have 2 blood draws before and after completing 30 minutes of exercise * C: Complete a threat task (self-paced rest condition) with self-report measures, a food challenge, and 30 minutes of rest.

Inclusion Criteria: * 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 Criteria: * 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

Locations (2)

University of California San Francisco

San Francisco, California, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States