CompletedNot Applicable

Response to Acute Exercise in Eating Disorders

United States74 participantsStarted 2023-11-02

Plain-language 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.

Who can participate

Age range

16 Years – 25 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Suicid…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response to in-lab exercise - body image

Timeframe: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.

Response to in-lab exercise - affect

Timeframe: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.

Response to in-lab exercise - biomarkers

Timeframe: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Trial details

NCT IDNCT06213883

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

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