Exercise Response for Eating Disorders

Recruiting at 1 trial location

Overseen By Katherine Schaumberg, PhD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Biobehavioral Response to in-lab exposure to physical activity, Driven Exercise Intervention, Physical Activity Therapy for eating disorders?

Research suggests that structured physical activity can provide cognitive benefits and improve brain function in individuals with eating disorders, potentially aiding in recovery. Additionally, exercise programs targeting exercise abuse in women with eating disorders have shown positive changes without interfering with weight gain, and promoting healthy physical activity has been found to reduce symptoms and concerns in individuals with bulimia nervosa. ^{1 2 3 4 5}

Is exercise therapy safe for individuals with eating disorders?

Research suggests that exercise programs designed to reduce exercise abuse in women with eating disorders are feasible and result in positive changes without interfering with weight gain, indicating they are generally safe when medically supervised. ^{1 3 4 6 7}

How does the exercise response treatment differ from other treatments for eating disorders?

This treatment is unique because it focuses on promoting healthy physical activity to improve emotional regulation and body image, which are key factors in eating disorder recovery. Unlike traditional therapies, it integrates structured exercise to potentially enhance neurocognitive function and reduce symptoms, offering a novel approach to treatment. ^{1 2 5 6 8}

Eligibility Criteria

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

My BMI is under 16 if I'm over 18, or my weight is less than 75% of the expected for my age if I'm under 18.

Current purging >1x per day

Trial Timeline

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

Treatment Details

Interventions

• Biobehavioral Response to in-lab exposure to physical activity (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

"I'm not physically active - I only go for walks": physical activity in patients with longstanding eating disorders. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The neurostructural and neurocognitive effects of physical activity: A potential benefit to promote eating disorder recovery. [2021]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Characterizing reasons for exercise in binge-spectrum eating disorders. [2023]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Registered report: A pilot investigation of acute exercise response among girls and young women with and without eating disorders. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Change in adaptive and maladaptive exercise and objective physical activity throughout CBT for individuals with eating disorders. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Physical activity and the drive to exercise in anorexia nervosa. [2022]