Heart Rate Sensing and Response in Persons With Anorexia Nervosa

Study Overview
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Brief Summary
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There are two major goals of this investigation. First, to develop pilot data to justify a larger randomized clinical trial of an intervention designed to train interoceptive signals (IS) and interoceptive responsivity (IR) in persons with Anorexia Nervosa (AN). Second, the investigators will determine whether persons with AN have similar or different IS and IR for heart rate while exercising as compared to age and gender matched controls.

Detailed Description
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The purpose of this pilot investigation is to assess AN interoceptive sensitivity and responsivity as it pertains to heart rate during exercise. Thirty adults, 18 years and older will be recruited for a cross-sectional comparison of IS and IR in the context of exercise.

Official Title
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Heart Rate Sensing and Response in Persons With Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Behavioral: One hour supervised exercise session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study participants will include adults with anorexia spectrum disorders and healthy age and gender matched controls. There will be two control groups, one that includes regularly exercising age and gender matched persons and one where controls do not engage in regular exercise. For those with AN, the following INCLUSION criteria must be met: Age ≥ 18 years old BMI 25 kg/m2 or less Diagnosis of anorexia spectrum disorder Medications: Stable use of all medications ≥ three months For age and gender matched controls, the following INCLUSION criteria must be met: Age ≥ 18 years old BMI 25 kg/m2 or less No diagnosis of anorexia spectrum disorder Medications: Stable use of all medications ≥ three months Age (+/- 2 years) and gender matched to study participant Exclusion Criteria: History of diabetes, heart disease or taking medications for those conditions History of hypertension (high blood pressure) not controlled with medication Orthopedic limitations, musculoskeletal disease and/or injury Inability to consent Lack of transportation to the Duke Center for Living campus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anorexia Nervosa (AN)<br>Diagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months. | Behavioral: One hour supervised exercise session<br>* All participants will participate in a one hour supervised exercise session. Participants will wear a physical activity monitor during the assessment for continuous monitoring of heart rate. Short, intense bouts of exercise will be interspersed with rest periods.<br>|
| Experimental: Matched Controls<br>No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Also age (+/- 2 years) and gender matched to AN study participant and exercise regularly. | Behavioral: One hour supervised exercise session<br>* All participants will participate in a one hour supervised exercise session. Participants will wear a physical activity monitor during the assessment for continuous monitoring of heart rate. Short, intense bouts of exercise will be interspersed with rest periods.<br>|
| Experimental: Healthy Controls<br>No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly. | Behavioral: One hour supervised exercise session<br>* All participants will participate in a one hour supervised exercise session. Participants will wear a physical activity monitor during the assessment for continuous monitoring of heart rate. Short, intense bouts of exercise will be interspersed with rest periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training | One exercise training session | Baseline only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia Nervosa, Exercise, Healthy Adults, Physical Activity