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Response to Acute Exercise in Eating Disorders

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Conditions

Eating DisordersaccelerometerAdolescentAerobic ExerciseBiological MarkersBody ImageAffectExerciseFemalesRewardsexercise intensityrestrictive eating

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-11-02
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06213883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 25 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 16-25
  2. * 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)
  3. * ED participants must be medically stable, and suitable for outpatient treatment
  4. * Biological Females, Assigned Female at birth
  5. * English Speaking
  1. * Those with a medical condition that precludes exercise (e.g., severe asthma) will be excluded for any contraindications
  2. * Biological Males, Assigned Male at birth
  3. * BMI less than 16 (over 18 years) or less than 75% expected body weight (under 18 years)
  4. * Reported intake on Eating Disorder Examination \<1000kcal daily
  5. * Current purging \>1x per day
  6. * Current regular episodes of objective binge eating (\>1x/wk)
  7. * Current self-report of loss-of control eating per the Eating Disorders Examination Interview
  8. * ED related hospitalization, partial hospitalization, or residential treatment in the past month
  9. * Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease).
  10. * Major medical disorders (e.g., cancer, AIDS)
  11. * Physical discomfort or difficulty with blood draws
  12. * Psychotic disorders
  13. * Intellectual disabilities
  14. * Developmental disorders
  15. * Active substance use disorder
  16. * Current suicidal risk per the Ask Suicide Screening Questionnaire
  17. * Pregnancy
  18. * Psychiatric medications that have not been stable for at least 4 weeks
  19. * 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
  20. * Resting heart rate \<50 beats per minute (assessed at screening visit)
  21. * Low blood pressure (\<90/60), (assessed at screening visit)
  22. * Daily cannabis use
  23. * History of light headedness or fainting during blood draws or physical activity
  24. * History of chest pain during physical activity
  25. * 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.
  26. * Physical disabilities that prohibit task performance (such as blindness or deafness)
  27. * Any other condition that the investigator believes might put the participant at risk for negative outcomes
  28. * Individuals with a restrictive eating disorder presentation that does not include weight and shape concern (ARFID) or that has primary binge eating (bulimia nervosa)
  29. * Indication of health risk associated with exercise on the Physical Activity Readiness Questionnaire

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • accelerometer
  • Adolescent
  • Aerobic Exercise
  • Biological Markers
  • Body Image
  • Affect
  • Exercise
  • Females
  • Rewards
  • exercise intensity
  • restrictive eating

Additional Relevant MeSH Terms

  • Eating Disorders