Eating DisordersNCT06213883

Response to Acute Exercise in Eating Disorders

A study testing Biobehavioral Response to in-lab exposure to physical activity in people with Eating Disorders, run by University of Wisconsin, Madison at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for: Eating Disorders
What is being tested?: Biobehavioral Response to in-lab exposure to physical activity
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 2 sitesUnited States
Study dates: 2 Nov 2023to 31 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 25 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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)

Show all 29Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Wisconsin-Madison
Madison, Wisconsin, 53719
University of California San Francisco
San Francisco, California, 94158

Other trials in United States

About this study

Official title: Characterizing Acute Exercise Response in Restrictive Eating Disorders

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.

Read the 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 efficacy is the persistence of driven exercise (DEx; exercising in a compulsive manner to control weight and/or regulate emotion), a hallmark symptom reported among many adolescents diagnosed with restrictive EDs (59-73%). Among other negative sequelae, DEx is associated with suicidal behavior, poorer treatment outcome, increased comorbid psychopathology, and risk for relapse. Further, while multiple eating-related tasks have been validated that discriminate between individuals with EDs and healthy populations, there are currently no well-validated tasks that directly assess sensitivity and responsivity to exercise in ED populations. As DEx is a poorly understood symptom that plays a key role in ED maintenance, investigating its biobehavioral underpinnings is of critical importance. Existing research points towards both reward and threat functions of exercise, which may drive and perpetuate DEx among those with EDs. Evaluation of both reward and threat functions of exercise among those with EDs will improve mechanistic understanding of this ED feature; ultimately, improved understanding of DEx will inform treatment targets.

The proposed project will recruit adolescent and young adult females (16-25y) with (n = 67) and without (n = 33) EDs from two sites to participate in a comprehensive evaluation of acute exercise response. The current project will

characterize variability in biobehavioral response to in-lab exposure to moderate-intensity exercise among those with and without EDs;
create and refine tasks that capture engagement of reward- and threat-related systems during exercise; and
test hypotheses that acute exercise response is more pronounced among individuals with EDs and that acute exercise response relates to ED symptom severity, DEx, and free-living activity.

Detailed explication of acute exercise effects among individuals with EDs in a controlled setting will have significant impact on the empirical study of EDs, specifically to (i) improve assessment of DEx risk and function (ii) elucidate a testable model of DEx risk and (iii) suggest targets for DEx intervention. The methods validated in this project will improve understanding of DEx, a treatment- resistant ED feature. These methods will also lay the groundwork for larger-scale, clinical research which clarifies optimal targets for DEx in ED treatment.

Conditions: Eating Disorders
Being tested: Biobehavioral Response to in-lab exposure to physical activity
Keywords: accelerometer, Adolescent, Aerobic Exercise, Biological Markers, Body Image, Affect, Exercise, Females, Rewards, exercise intensity, restrictive eating
Medical subject headings: Feeding and Eating Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Biobehavioral Response to in-lab exposure to physical activityOther
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.

Study groups in NCT06213883
Study group	Role	What they receive
Healthy Controls	Experimental	Study participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days Receives: Other: Biobehavioral Response to in-lab exposure to physical activity
Participants with Eating Disorders	Experimental	Study participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days Receives: Other: Biobehavioral Response to in-lab exposure to physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Image State Scale (BISS) Score: Average of All BISS 6-items
Response to body image was measured using the BISS which is a 6-item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Measured: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Appearance-Item Score From Body Image State Scale (BISS)
Response to body image was measured using the BISS which is a 6-item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale(1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Measured: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Average Person-Item Score From Body Image State Scale (BISS)
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). The Average Person item asks participants to rate how they feel like they look compared to the average person from a great deal worse (1) to a great deal better (9). Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Measured: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Looks-Item Score From Body Image State Scale (BISS)
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Measured: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Physical Attraction-Item Score From Body Image State Scale (BISS)
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Measured: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Shape-Item Score From Body Image State Scale (BISS)
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Measured: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Weight-Item Score From Body Image State Scale (BISS)
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Measured: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Anxious-Item Score
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Measured: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Calm-Item Score
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Measured: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Crummy-Item Score
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Measured: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Enthusiastic-Item Score
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Measured: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Physical Activity Affect Scale (PAAS): Fatigued-Item Score
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Measured: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Borg Rating of Perceived Exertion (RPE) Score
Participants were surveyed for their perceived exertion throughout the exercise conditions only. The Borg Rating of Perceived Exertion (RPE) scale was used to measure perceived exertion, rated 6 to 20 (no exertion to maximal exertion).
Measured: 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: Circulating BDNF (ng/mL)
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:
- circulating leptin (leptin immunoassay)
- circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
- circulating brain-derived neurotrophic factor (BDNF immunoassay)
- circulating cortisol (Cortisol immunoassay)
Measured: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating Leptin (ng/mL)
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:
- circulating leptin (leptin immunoassay)
- circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
- circulating brain-derived neurotrophic factor (BDNF immunoassay)
- circulating cortisol (Cortisol immunoassay)
Measured: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating Cortisol (μg/dL)
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:
- circulating leptin (leptin immunoassay)
- circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
- circulating brain-derived neurotrophic factor (BDNF immunoassay)
- circulating cortisol (Cortisol immunoassay)
Measured: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating Anandamide (AEA) (ng/mL)
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:
- circulating leptin (leptin immunoassay)
- circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
- circulating brain-derived neurotrophic factor (BDNF immunoassay)
- circulating cortisol (Cortisol immunoassay)
Measured: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Response to In-lab Exercise - Biomarkers: Circulating 2-arachidonoylglycerol (2-AG) (ng/mL)
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits:
- circulating leptin (leptin immunoassay)
- circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays)
- circulating brain-derived neurotrophic factor (BDNF immunoassay)
- circulating cortisol (Cortisol immunoassay)
Measured: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 202331 Jul 2025

First posted19 Jan 2024
Study start2 Nov 2023
Primary completion31 Jul 2025
Study completion31 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (156)Papers the sponsor has linked to this study.
Other trials for Eating DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Individuals Complete Exercise and Rest Sessions in-lab. To evaluate the impact of exercise on affect, body image, and biomarkers
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06213883
Sponsor's protocol ID: 2019-1585
Other IDs: 1R21MH131787-01A1
Status last verified: Jul 2026
First submitted: 9 Jan 2024
Last updated: 25 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Project publications will provide full information about procedures and analyses to enable replication. We will share data and code on an institutional webpage for reproducibility.

Publications

Schaumberg K, Welch E, Breithaupt L, Hubel C, Baker JH, Munn-Chernoff MA, Yilmaz Z, Ehrlich S, Mustelin L, Ghaderi A, Hardaway AJ, Bulik-Sullivan EC, Hedman AM, Jangmo A, Nilsson IAK, Wiklund C, Yao S, Seidel M, Bulik CM. The Science Behind the Academy for Eating Disorders' Nine Truths About Eating Disorders. Eur Eat Disord Rev. 2017 Nov;25(6):432-450. doi: 10.1002/erv.2553. Epub 2017 Oct 2.
PubMed 28967161
Steinhausen HC. Outcome of eating disorders. Child Adolesc Psychiatr Clin N Am. 2009 Jan;18(1):225-42. doi: 10.1016/j.chc.2008.07.013.
PubMed 19014869
Pisetsky EM, Thornton LM, Lichtenstein P, Pedersen NL, Bulik CM. Suicide attempts in women with eating disorders. J Abnorm Psychol. 2013 Nov;122(4):1042-56. doi: 10.1037/a0034902.
PubMed 24364606
Kolar DR, Gorrell S. A call to experimentally study acute affect-regulation mechanisms specific to driven exercise in eating disorders. Int J Eat Disord. 2020 Dec 1:10.1002/eat.23427. doi: 10.1002/eat.23427. Online ahead of print.
PubMed 33289120
Smith AR, Fink EL, Anestis MD, Ribeiro JD, Gordon KH, Davis H, Keel PK, Bardone-Cone AM, Peterson CB, Klein MH, Crow S, Mitchell JE, Crosby RD, Wonderlich SA, le Grange D, Joiner TE Jr. Exercise caution: over-exercise is associated with suicidality among individuals with disordered eating. Psychiatry Res. 2013 Apr 30;206(2-3):246-55. doi: 10.1016/j.psychres.2012.11.004. Epub 2012 Dec 7.
PubMed 23219104
Dalle Grave R, Calugi S, Marchesini G. Compulsive exercise to control shape or weight in eating disorders: prevalence, associated features, and treatment outcome. Compr Psychiatry. 2008 Jul-Aug;49(4):346-52. doi: 10.1016/j.comppsych.2007.12.007. Epub 2008 Mar 19.
PubMed 18555054
Carter JC, Blackmore E, Sutandar-Pinnock K, Woodside DB. Relapse in anorexia nervosa: a survival analysis. Psychol Med. 2004 May;34(4):671-9. doi: 10.1017/S0033291703001168.
PubMed 15099421
Holtkamp K, Herpertz-Dahlmann B, Hebebrand K, Mika C, Kratzsch J, Hebebrand J. Physical activity and restlessness correlate with leptin levels in patients with adolescent anorexia nervosa. Biol Psychiatry. 2006 Aug 1;60(3):311-3. doi: 10.1016/j.biopsych.2005.11.001. Epub 2005 Dec 27.
PubMed 16376860
Greenwood BN, Foley TE, Le TV, Strong PV, Loughridge AB, Day HE, Fleshner M. Long-term voluntary wheel running is rewarding and produces plasticity in the mesolimbic reward pathway. Behav Brain Res. 2011 Mar 1;217(2):354-62. doi: 10.1016/j.bbr.2010.11.005. Epub 2010 Nov 9.
PubMed 21070820
Sawyer SM, Whitelaw M, Le Grange D, Yeo M, Hughes EK. Physical and Psychological Morbidity in Adolescents With Atypical Anorexia Nervosa. Pediatrics. 2016 Apr;137(4):e20154080. doi: 10.1542/peds.2015-4080. Epub 2016 Mar 29.
PubMed 27025958
Sysko R, Steinglass J, Schebendach J, Mayer LES, Walsh BT. Rigor and reproducibility via laboratory studies of eating behavior: A focused update and conceptual review. Int J Eat Disord. 2018 Jul;51(7):608-616. doi: 10.1002/eat.22900. Epub 2018 Aug 21.
PubMed 30132949
Herring MP, Sailors MH, Bray MS. Genetic factors in exercise adoption, adherence and obesity. Obes Rev. 2014 Jan;15(1):29-39. doi: 10.1111/obr.12089. Epub 2013 Sep 15.
PubMed 24034448
Flack K, Pankey C, Ufholz K, Johnson L, Roemmich JN. Genetic variations in the dopamine reward system influence exercise reinforcement and tolerance for exercise intensity. Behav Brain Res. 2019 Dec 16;375:112148. doi: 10.1016/j.bbr.2019.112148. Epub 2019 Aug 9.
PubMed 31404557
Heyman E, Gamelin FX, Goekint M, Piscitelli F, Roelands B, Leclair E, Di Marzo V, Meeusen R. Intense exercise increases circulating endocannabinoid and BDNF levels in humans--possible implications for reward and depression. Psychoneuroendocrinology. 2012 Jun;37(6):844-51. doi: 10.1016/j.psyneuen.2011.09.017. Epub 2011 Oct 24.
PubMed 22029953
Herring MP, O'Connor PJ, Dishman RK. The effect of exercise training on anxiety symptoms among patients: a systematic review. Arch Intern Med. 2010 Feb 22;170(4):321-31. doi: 10.1001/archinternmed.2009.530.
PubMed 20177034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterizing Acute Exercise Response in Restrictive Eating Disorders
ClinicalTrials.gov ID: NCT06213883
Acronym / sponsor ID: 2019-1585
Conditions: Eating Disorders
Keywords: accelerometer, Adolescent, Aerobic Exercise, Biological Markers, Body Image, Affect, Exercise, Females
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 2 Nov 2023 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Jul 2025 (actual)
First posted: 19 Jan 2024 (actual)
Results: Posted 25 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

characterize variability in biobehavioral response to in-lab exposure to moderate-intensity exercise among those with and without EDs;
create and refine tasks that capture engagement of reward- and threat-related systems during exercise; and
test hypotheses that acute exercise response is more pronounced among individuals with EDs and that acute exercise response relates to ED symptom severity, DEx, and free-living activity.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Individuals Complete Exercise and Rest Sessions in-lab. To evaluate the impact of exercise on affect, body image, and biomarkers

Arm	Type	Receives
Healthy Controls	Experimental	Other: Biobehavioral Response to in-lab exposure to physical activityStudy participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days
Participants with Eating Disorders	Experimental	Other: Biobehavioral Response to in-lab exposure to physical activityStudy participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days

Who may qualify

Ages: 16 to 25 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (29 listed)

Those with a medical condition that precludes exercise (e.g., severe asthma) will be excluded for any contraindications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Biobehavioral Response to in-lab exposure to physical activityED 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.	Other	Healthy Controls, Participants with Eating Disorders

Primary outcome

Body Image State Scale (BISS) Score: Average of All BISS 6-items
Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6-item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Appearance-Item Score From Body Image State Scale (BISS)
Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6-item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale(1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Average Person-Item Score From Body Image State Scale (BISS)
Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). The Average Person item asks participants to rate how they feel like they look compared to the average person from a great deal worse (1) to a great deal better (9). Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Looks-Item Score From Body Image State Scale (BISS)
Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Physical Attraction-Item Score From Body Image State Scale (BISS)
Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Shape-Item Score From Body Image State Scale (BISS)
Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Weight-Item Score From Body Image State Scale (BISS)
Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.
Response to body image was measured using the BISS which is a 6 item scale that asks participants to report on their momentary body satisfaction on a 9-point Likert scale (1-9, higher scores, higher satisfaction). Each item begins with the sentence "Right now, I feel" [for instance: "Right now, I feel (Extremely dissatisfied to Extremely satisfied)"]. Participants are asked to rate their momentary body satisfaction every five minutes during each of 4 conditions: Prescribed Exercise (Reward Task), Self-Paced Exercise (Threat Task), Prescribed Rest (Reward Task), or Self-Paced Rest (Threat Task).
Physical Activity Affect Scale (PAAS): Anxious-Item Score
Time frame: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Physical Activity Affect Scale (PAAS): Calm-Item Score
Time frame: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Physical Activity Affect Scale (PAAS): Crummy-Item Score
Time frame: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Physical Activity Affect Scale (PAAS): Enthusiastic-Item Score
Time frame: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Physical Activity Affect Scale (PAAS): Fatigued-Item Score
Time frame: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants self-report items representing the highest loading items from the Physical Activity Affect Scale (PAAS) every 5 minutes during exercise. These items include feeling 'Anxious', 'Crummy', 'Enthusiastic', 'Fatigued' and 'Calm'. Participants rate each item using a 5-point scale (0=do not feel-4=feel very strongly).
Borg Rating of Perceived Exertion (RPE) Score
Time frame: Every 5 minutes during a 30 minute bout of activity. There is no follow up beyond the study day itself.
Participants were surveyed for their perceived exertion throughout the exercise conditions only. The Borg Rating of Perceived Exertion (RPE) scale was used to measure perceived exertion, rated 6 to 20 (no exertion to maximal exertion).
Response to In-lab Exercise - Biomarkers: Circulating BDNF (ng/mL)
Time frame: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits: * circulating leptin (leptin immunoassay) * circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays) * circulating brain-derived neurotrophic factor (BDNF immunoassay) * circulating cortisol (Cortisol immunoassay)
Response to In-lab Exercise - Biomarkers: Circulating Leptin (ng/mL)
Time frame: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits: * circulating leptin (leptin immunoassay) * circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays) * circulating brain-derived neurotrophic factor (BDNF immunoassay) * circulating cortisol (Cortisol immunoassay)
Response to In-lab Exercise - Biomarkers: Circulating Cortisol (μg/dL)
Time frame: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits: * circulating leptin (leptin immunoassay) * circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays) * circulating brain-derived neurotrophic factor (BDNF immunoassay) * circulating cortisol (Cortisol immunoassay)
Response to In-lab Exercise - Biomarkers: Circulating Anandamide (AEA) (ng/mL)
Time frame: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits: * circulating leptin (leptin immunoassay) * circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays) * circulating brain-derived neurotrophic factor (BDNF immunoassay) * circulating cortisol (Cortisol immunoassay)
Response to In-lab Exercise - Biomarkers: Circulating 2-arachidonoylglycerol (2-AG) (ng/mL)
Time frame: pre-exercise (Baseline), post-exercise (30 minutes), pre-rest (Baseline), post-rest (30 minutes). There is no follow up beyond the study day itself.
Biomarkers will be collected via blood samples taken before and after exercise and rest and measured via Enzyme-linked immunosorbent assay (ELISA) kits: * circulating leptin (leptin immunoassay) * circulating endocannabinoids (2-arachidonoylglycerol (2-AG) and anandamide (AEA) plasma-based immunoassays) * circulating brain-derived neurotrophic factor (BDNF immunoassay) * circulating cortisol (Cortisol immunoassay)

Results and safety

Results posted to the registry on 25 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Controls	30	30
Participants With Eating Disorders	44	44

Primary outcome: Body Image State Scale (BISS) Score: Average of All BISS 6-items

Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.. Mean (Standard Deviation). Unit: score on a scale

Measure	Healthy Controls: Prescribed Exercise n = 30	Healthy Controls: Self-Paced Exercise n = 30	Healthy Controls: Prescribed Rest n = 30	Healthy Controls: Self-Paced Rest n = 30	Participants With Eating Disorders: Prescribed Exercise n = 44	Participants With Eating Disorders: Self-Paced Exercise n = 44	Participants With Eating Disorders: Prescribed Rest n = 44	Participants With Eating Disorders: Self-Paced Rest n = 44
baseline	5.78 (0.85)	5.72 (0.97)	5.74 (1.07)	5.80 (0.90)	4.16 (1.05)	4.09 (1.18)	3.99 (1.00)	3.93 (1.28)
5 minutes	5.72 (0.80)	5.67 (0.96)	5.68 (0.93)	5.76 (0.90)	4.24 (1.07)	4.22 (1.11)	4.04 (0.94)	3.88 (1.19)
10 minutes	5.71 (0.80)	5.64 (0.94)	5.67 (0.98)	5.73 (0.89)	4.19 (1.07)	4.20 (1.12)	4.05 (1.03)	3.98 (1.21)
15 minutes	5.61 (0.80)	5.68 (0.98)	5.73 (0.99)	5.78 (0.91)	4.22 (1.10)	4.27 (1.17)	4.00 (1.11)	4.00 (1.25)
20 minutes	5.57 (0.82)	5.68 (0.98)	5.69 (0.98)	5.73 (0.88)	4.23 (1.16)	4.38 (1.15)	4.07 (1.10)	4.03 (1.27)
25 minutes	5.54 (0.85)	5.68 (0.94)	5.68 (1.01)	5.76 (0.92)	4.17 (1.18)	4.33 (1.15)	4.07 (1.13)	4.05 (1.26)
30 minutes	5.58 (0.83)	5.64 (0.96)	5.73 (1.02)	5.75 (0.90)	4.28 (1.22)	4.40 (1.13)	4.03 (1.08)	4.04 (1.33)

Primary outcome: Appearance-Item Score From Body Image State Scale (BISS)

Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.. Mean (Standard Deviation). Unit: score on a scale

Measure	Healthy Controls: Prescribed Exercise n = 30	Healthy Controls: Self-Paced Exercise n = 30	Healthy Controls: Prescribed Rest n = 30	Healthy Controls: Self-Paced Rest n = 30	Participants With Eating Disorders: Prescribed Exercise n = 44	Participants With Eating Disorders: Self-Paced Exercise n = 44	Participants With Eating Disorders: Prescribed Rest n = 44	Participants With Eating Disorders: Self-Paced Rest n = 44
baseline	6.03 (1.32)	6.03 (1.40)	6.23 (1.67)	6.20 (1.92)	4.07 (1.31)	4.09 (1.36)	3.70 (1.46)	3.24 (1.74)
5 minutes	6.03 (1.30)	6.10 (1.40)	6.00 (1.36)	6.10 (1.47)	4.23 (1.21)	4.23 (1.36)	3.86 (1.08)	3.76 (1.48)
10 minutes	5.93 (1.31)	6.07 (1.39)	6.03 (1.35)	6.07 (1.14)	4.21 (1.19)	4.12 (1.31)	4.00 (1.25)	3.88 (1.52)
15 minutes	5.76 (1.38)	6.07 (1.39)	6.10 (1.37)	6.00 (1.36)	4.19 (1.24)	4.23 (1.39)	4.00 (1.29)	3.93 (1.47)
20 minutes	5.79 (1.34)	6.14 (1.43)	6.03 (1.38)	6.03 (1.43)	4.23 (1.32)	4.47 (1.42)	4.07 (1.35)	4.05 (1.50)
25 minutes	5.82 (1.28)	6.07 (1.39)	6.03 (1.43)	6.07 (1.44)	4.23 (1.34)	4.37 (1.38)	4.05 (1.33)	4.07 (1.44)
30 minutes	5.86 (1.24)	6.10 (1.42)	6.07 (1.46)	6.03 (1.43)	4.37 (1.45)	4.37 (1.36)

Primary outcome: Average Person-Item Score From Body Image State Scale (BISS)

Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.. Mean (Standard Deviation). Unit: score on a scale

Measure	Healthy Controls: Prescribed Exercise n = 30	Healthy Controls: Self-Paced Exercise n = 30	Healthy Controls: Prescribed Rest n = 30	Healthy Controls: Self-Paced Rest n = 30	Participants With Eating Disorders: Prescribed Exercise n = 44	Participants With Eating Disorders: Self-Paced Exercise n = 44	Participants With Eating Disorders: Prescribed Rest n = 44	Participants With Eating Disorders: Self-Paced Rest n = 44
baseline	5.17 (0.71)	5.17 (0.76)	5.13 (0.78)	5.07 (0.78)	4.31 (1.39)	4.21 (1.41)	4.27 (1.39)	4.26 (1.70)
5 minutes	5.10 (0.67)	5.07 (0.75)	5.10 (0.67)	5.13 (0.68)	4.42 (1.24)	4.37 (1.22)	4.23 (1.32)	4.17 (1.48)
10 minutes	5.14 (0.74)	5.07 (0.75)	5.10 (0.82)	5.07 (0.64)	4.26 (1.38)	4.35 (1.23)	4.23 (1.29)	4.24 (1.39)
15 minutes	5.10 (0.72)	5.17 (0.80)	5.14 (0.83)	5.23 (0.68)	4.28 (1.33)	4.37 (1.29)	4.14 (1.39)	4.17 (1.41)
20 minutes	5.04 (0.64)	5.10 (0.77)	5.14 (0.83)	5.17 (0.65)	4.23 (1.39)	4.47 (1.30)	4.23 (1.38)	4.07 (1.44)
25 minutes	4.89 (0.74)	5.14 (0.74)	5.14 (0.83)	5.13 (0.68)	4.26 (1.42)	4.40 (1.31)	4.21 (1.37)	4.17 (1.43)
30 minutes	4.93 (0.72)	5.00 (0.80)	5.14 (0.83)	5.13 (0.63)	4.30 (1.37)	4.37 (1.27)

Primary outcome: Looks-Item Score From Body Image State Scale (BISS)

Time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.. Mean (Standard Deviation). Unit: score on a scale

Measure	Healthy Controls: Prescribed Exercise n = 30	Healthy Controls: Self-Paced Exercise n = 30	Healthy Controls: Prescribed Rest n = 30	Healthy Controls: Self-Paced Rest n = 30	Participants With Eating Disorders: Prescribed Exercise n = 44	Participants With Eating Disorders: Self-Paced Exercise n = 44	Participants With Eating Disorders: Prescribed Rest n = 44	Participants With Eating Disorders: Self-Paced Rest n = 44
baseline	5.07 (0.75)	5.10 (0.82)	4.87 (1.18)	4.83 (0.79)	4.57 (1.06)	4.37 (1.07)	4.38 (0.98)	4.55 (1.35)
5 minutes	5.07 (0.70)	5.10 (0.82)	5.10 (0.90)	5.13 (0.78)	4.56 (0.93)	4.49 (0.88)	4.58 (0.70)	4.31 (1.00)
10 minutes	5.24 (0.74)	5.03 (0.78)	4.97 (0.82)	5.07 (0.74)	4.56 (0.96)	4.47 (0.85)	4.40 (0.82)	4.38 (0.99)
15 minutes	5.00 (0.65)	5.17 (0.89)	5.10 (0.94)	5.07 (0.69)	4.58 (1.03)	4.60 (0.95)	4.42 (1.01)	4.36 (0.96)
20 minutes	4.93 (0.77)	5.10 (0.77)	5.03 (0.87)	5.07 (0.64)	4.51 (1.08)	4.72 (0.91)	4.44 (0.91)	4.36 (1.14)
25 minutes	4.86 (0.80)	5.14 (0.83)	5.03 (0.87)	5.10 (0.71)	4.42 (1.20)	4.60 (0.95)	4.40 (1.00)	4.33 (0.95)
30 minutes	4.96 (0.74)	5.07 (0.88)	5.07 (0.92)	5.03 (0.67)	4.53 (1.12)	4.67 (0.92)

Adverse events

Time frame: 30 minute study visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Controls	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Participants With Eating Disorders	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28967161Schaumberg K, Welch E, Breithaupt L, Hubel C, Baker JH, Munn-Chernoff MA, Yilmaz Z, Ehrlich S, Mustelin L, Ghaderi A, Hardaway AJ, Bulik-Sullivan EC, Hedman AM, Jangmo A, Nilsson IAK, Wiklund C, Yao S, Seidel M, Bulik CM. The Science Behind the Academy for Eating Disorders' Nine Truths About Eating Disorders. Eur Eat Disord Rev. 2017 Nov;25(6):432-450. doi: 10.1002/erv.2553. Epub 2017 Oct 2.
Background: PubMed 19014869Steinhausen HC. Outcome of eating disorders. Child Adolesc Psychiatr Clin N Am. 2009 Jan;18(1):225-42. doi: 10.1016/j.chc.2008.07.013.
Background: PubMed 24364606Pisetsky EM, Thornton LM, Lichtenstein P, Pedersen NL, Bulik CM. Suicide attempts in women with eating disorders. J Abnorm Psychol. 2013 Nov;122(4):1042-56. doi: 10.1037/a0034902.
Background: PubMed 33289120Kolar DR, Gorrell S. A call to experimentally study acute affect-regulation mechanisms specific to driven exercise in eating disorders. Int J Eat Disord. 2020 Dec 1:10.1002/eat.23427. doi: 10.1002/eat.23427. Online ahead of print.
Background: PubMed 23219104Smith AR, Fink EL, Anestis MD, Ribeiro JD, Gordon KH, Davis H, Keel PK, Bardone-Cone AM, Peterson CB, Klein MH, Crow S, Mitchell JE, Crosby RD, Wonderlich SA, le Grange D, Joiner TE Jr. Exercise caution: over-exercise is associated with suicidality among individuals with disordered eating. Psychiatry Res. 2013 Apr 30;206(2-3):246-55. doi: 10.1016/j.psychres.2012.11.004. Epub 2012 Dec 7.
Background: PubMed 18555054Dalle Grave R, Calugi S, Marchesini G. Compulsive exercise to control shape or weight in eating disorders: prevalence, associated features, and treatment outcome. Compr Psychiatry. 2008 Jul-Aug;49(4):346-52. doi: 10.1016/j.comppsych.2007.12.007. Epub 2008 Mar 19.
Background: PubMed 15099421Carter JC, Blackmore E, Sutandar-Pinnock K, Woodside DB. Relapse in anorexia nervosa: a survival analysis. Psychol Med. 2004 May;34(4):671-9. doi: 10.1017/S0033291703001168.
Background: PubMed 16376860Holtkamp K, Herpertz-Dahlmann B, Hebebrand K, Mika C, Kratzsch J, Hebebrand J. Physical activity and restlessness correlate with leptin levels in patients with adolescent anorexia nervosa. Biol Psychiatry. 2006 Aug 1;60(3):311-3. doi: 10.1016/j.biopsych.2005.11.001. Epub 2005 Dec 27.
Background: PubMed 21070820Greenwood BN, Foley TE, Le TV, Strong PV, Loughridge AB, Day HE, Fleshner M. Long-term voluntary wheel running is rewarding and produces plasticity in the mesolimbic reward pathway. Behav Brain Res. 2011 Mar 1;217(2):354-62. doi: 10.1016/j.bbr.2010.11.005. Epub 2010 Nov 9.
Background: PubMed 27025958Sawyer SM, Whitelaw M, Le Grange D, Yeo M, Hughes EK. Physical and Psychological Morbidity in Adolescents With Atypical Anorexia Nervosa. Pediatrics. 2016 Apr;137(4):e20154080. doi: 10.1542/peds.2015-4080. Epub 2016 Mar 29.
Background: PubMed 30132949Sysko R, Steinglass J, Schebendach J, Mayer LES, Walsh BT. Rigor and reproducibility via laboratory studies of eating behavior: A focused update and conceptual review. Int J Eat Disord. 2018 Jul;51(7):608-616. doi: 10.1002/eat.22900. Epub 2018 Aug 21.
Background: PubMed 24034448Herring MP, Sailors MH, Bray MS. Genetic factors in exercise adoption, adherence and obesity. Obes Rev. 2014 Jan;15(1):29-39. doi: 10.1111/obr.12089. Epub 2013 Sep 15.
Individual participant dataSharing planned: Yes. Project publications will provide full information about procedures and analyses to enable replication. We will share data and code on an institutional webpage for reproducibility.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biobehavioral Response to in-lab exposure to physical activity in people with Eating Disorders, run by University of Wisconsin, Madison at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Image State Scale (BISS) Score: Average of All BISS 6-items (time frame: Every 5 minutes during 30 minute bout of activity . There is no follow up beyond the study day itself.). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06213883, which also lists 156 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.