Exercise Response for Eating Disorders

No longer recruiting at 1 trial location

Overseen By Katherine Schaumberg, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Psychiatric medications, Sedatives, Pain killers, Stimulants

Disqualifiers: Psychotic disorders, Intellectual disabilities, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how young females with specific eating disorders respond to exercise. Researchers seek to determine how exercise affects their thoughts, feelings, and body reactions to develop targeted treatments for driven exercise, a common symptom in these disorders. Participants will engage in various physical activity levels, including set exercises, self-paced exercises, and rest. Eligible participants include females aged 16-25 with certain eating disorders, such as anorexia nervosa, who can safely participate in exercise. The study aims to improve future treatments for eating disorders by examining exercise's role. As an unphased study, this trial offers participants the chance to contribute to pioneering research that could lead to better treatment options for eating disorders.

Will I have to stop taking my current medications?

The trial requires that psychiatric medications be stable for at least 4 weeks before participation. Additionally, certain medications like sedatives, pain killers, and prescription stimulants must not be taken the day before the lab session.

What prior data suggests that this method is safe for individuals with eating disorders?

Research shows that exercise can affect people with eating disorders (EDs) in various ways. Previous studies have focused on young women with EDs, aiming to understand changes in their thoughts, feelings, and body responses during and after exercise.

In this trial, researchers will observe how participants respond to different physical activities in a controlled environment. This trial does not test a new medication or typical treatment; it gathers information. Current research indicates no serious safety concerns with this type of exercise exposure. Participants will engage in planned exercise, exercise at their own pace, and rest over three study days.

This study aims to learn more about the effects of exercise, not to test a new drug or therapy. So far, exercise in these studies has been well-tolerated, with no major side effects reported. Participants will be closely monitored to ensure their safety during the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise Response for Eating Disorders trial because it explores how different types of physical activity might influence recovery in a way that current treatments don't. Unlike standard therapy and medication options, which focus primarily on psychological and nutritional interventions, this approach examines the biobehavioral response to exercise. By looking at prescribed exercise, self-paced exercise, and rest, the study aims to uncover how these activities can help regulate eating behaviors and improve mental well-being. This could lead to new, complementary strategies that enhance existing treatment plans for eating disorders.

What evidence suggests that this trial's treatments could be effective for eating disorders?

Research has shown that exercise positively affects people with eating disorders (EDs). Studies have found that exercise can improve body mass index (BMI) and reduce binge-eating behaviors, particularly in those with binge eating disorder. It can also lead to physical changes and better moods. In this trial, participants will undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions to evaluate their response to exercise. For people with EDs, exercise might help manage symptoms like the strong urge to exercise excessively. These findings suggest that exercise could play a crucial role in treating EDs, improving overall outcomes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adolescent and young adult females with eating disorders. It aims to understand how they respond to exercise, both mentally and physically. Participants should be experiencing driven exercise, a common symptom in those with eating disorders.

Inclusion Criteria

I am a biological female, assigned female at birth.

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

I am between 16 and 22 years old.

Exclusion Criteria

Active substance use disorder

Current purging >1x per day

I haven't taken any sedatives, painkillers, or ADHD medication the day before the lab session.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise and Rest Conditions

Participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days

3 days

3 visits (in-person)

Data Collection and Analysis

Biomarkers and self-reported data are collected during exercise and rest conditions to assess body image, biomarkers, and affect

Concurrent with exercise and rest conditions

Follow-up

Participants are monitored for safety and effectiveness after treatment

No follow-up beyond study days

What Are the Treatments Tested in This Trial?

Interventions

• Biobehavioral Response to in-lab exposure to physical activity

Trial Overview The study is looking at the immediate cognitive, emotional, and biological reactions to physical activity in participants. The goal is to link these responses with their regular activity levels and the compulsion for excessive exercise.

How Is the Trial Designed?

Group I: Response to Exercise and Rest Experimental Treatment 1 Intervention

Study participants undergo Prescribed Exercise, Self-Paced Exercise, and Rest conditions over the course of 3 study days

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Patients with longstanding eating disorders reported lower levels of moderate-to-vigorous physical activity (MVPA) than what was objectively measured, indicating potential underreporting of their activity levels.

The primary motivation for exercise in patients with eating disorders was to regulate negative emotions rather than for weight or appearance, contrasting with controls who placed more importance on fitness and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I'm not physically active - I only go for walks": physical activity in patients with longstanding eating disorders. Bratland-Sanda, S., Sundgot-Borgen, J., Rø, O., et al.[2022]

In a study of 58 adults with binge-spectrum eating disorders, 73% of reported exercise episodes were classified as maladaptive, with the most common reasons being to control shape or weight (67.2%) and feeling driven to exercise (62.9%).

Participants reported an average of 3.6 reasons for exercising per episode, indicating that motivations for exercise can be complex and vary, highlighting the need for targeted interventions that address both adaptive and maladaptive exercise behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing reasons for exercise in binge-spectrum eating disorders. Lampe, EW., Trainor, C., Presseller, EK., et al.[2023]

Supervised and adapted physical activity may provide cognitive benefits for individuals with eating disorders, although the exact mechanisms behind these benefits are not well understood.

The authors suggest that physical activity could lead to positive neurostructural and neurocognitive changes, which may be crucial for effective treatment and recovery from eating disorders, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neurostructural and neurocognitive effects of physical activity: A potential benefit to promote eating disorder recovery. Mathisen, TF., Sundgot-Borgen, J., Bulik, CM., et al.[2021]

A 12-session healthy physical activity (PA) promotion intervention for bulimia nervosa (BN) was found to be feasible and acceptable, leading to significant decreases in BN symptoms, negative affect, and concerns about shape and weight in a small case series of 3 participants.

This study suggests that incorporating physical activity into treatment for BN may enhance outcomes by improving emotional regulation and body image, although further research with larger samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Target Engagement of a Healthy Physical Activity Promotion Intervention for Bulimia Nervosa: Development and Evaluation via Case Series Design. Lampe, EW., Forman, EM., Juarascio, AS., et al.[2023]

In a 12-week CBT treatment study involving 30 adults with eating disorders, maladaptive exercise significantly decreased in individuals who initially engaged in it, while adaptive exercise levels remained stable across both groups.

Although the non-maladaptive exercise group increased their minutes of moderate-to-vigorous physical activity during treatment, these changes in physical activity were not linked to improvements in eating disorder symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in adaptive and maladaptive exercise and objective physical activity throughout CBT for individuals with eating disorders. Wons, O., Lampe, E., Patarinski, AG., et al.[2023]

The study will assess the acute psychobiological responses to exercise in 40 female participants (20 with restrictive-spectrum eating disorders and 20 healthy controls) through two 30-minute aerobic exercise sessions.

By examining changes in body image, affect, and biological markers, the research aims to understand how exercise influences psychological outcomes differently in individuals with eating disorders compared to healthy individuals, which could help in addressing driven exercise behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Registered report: A pilot investigation of acute exercise response among girls and young women with and without eating disorders. Schaumberg, K., Peters, D., Ahrenholtz, R., et al.[2022]

Women with eating disorders who participated in a structured exercise program during residential treatment gained more weight compared to those who did not participate, particularly those diagnosed with anorexia nervosa.

The exercise program also led to a significant reduction in obligatory attitudes toward exercise among participants, indicating a positive shift in their relationship with exercise without hindering weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice and process of healthy exercise: an investigation of the treatment of exercise abuse in women with eating disorders. Calogero, RM., Pedrotty, KN.[2022]

In a study involving 119 female participants across different groups, those with anorexia nervosa (AN) reported significantly higher levels of physical activity (PA) compared to healthy controls, despite no objective differences in activity levels measured by actigraphy.

The drive to exercise in individuals with AN is more closely linked to eating disorder pathology rather than anxiety, indicating that their motivations for exercise may be influenced by their condition rather than general psychological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and the drive to exercise in anorexia nervosa. Keyes, A., Woerwag-Mehta, S., Bartholdy, S., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06213883/response-to-acute-exercise-in-eating-disorders

Response to Acute Exercise in Eating Disorders This study will develop tasks to characterize cognitive, affective, and biological response to exercise among adolescent and young adult females ...

2. withpower.com withpower.com/trial/exercise-response-for-eating-disorders-23bbd

Exercise Response for Eating Disorders · Info for Participants This study will develop tasks to characterize cognitive, affective, and biological response to exercise among adolescent and young adult females with EDs and ...

3. trialx.com trialx.com/clinical-trials/listings/267491/response-to-acute-exercise-in-eating-disorders/?&radius=50&query=Treatment%20outcome&smt=true

Response to Acute Exercise in Eating Disorders This study will develop tasks to characterize cognitive, affective, and biological response to exercise among adolescent and young adult females ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4911228/

Exercise in Eating Disorders Treatment: Systematic Review ... Although exercise is an effective intervention for many psychological health issues, it has often been overlooked as a potential adjunct to ED treatment.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999322006347

Efficacy of Exercise Interventions Applied to Populations ... Exercise had a positive effect on BMI and frequency of binge-eating behaviors in individuals with binge eating disorder. Physiological measures were also ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8595629/

A pilot investigation of acute exercise response among girls ... Registered Report: A pilot investigation of acute exercise response among girls and young women with and without eating disorders · Abstract. Driven exercise ( ...

7. researchgate.net researchgate.net/publication/353581914_Registered_report_A_pilot_investigation_of_acute_exercise_response_among_girls_and_young_women_with_and_without_eating_disorders

A pilot investigation of acute exercise response among ... Registered report: A pilot investigation of acute exercise response among girls and young women with and without eating disorders ... To read the ...