Heart Rate Sensing and Response in Persons With Anorexia Nervosa

Not Applicable

Completed

• Conditions: Anorexia Nervosa
• Interventions: Behavioral: One hour supervised exercise session

• Registration Number: NCT02579018
• Lead Sponsor: Duke University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Study Start: 2016-03
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-30
• Last Update Posted: 2017-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anorexia Nervosa (AN)	One hour supervised exercise session	Diagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months.
Matched Controls	One hour supervised exercise session	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.
Healthy Controls	One hour supervised exercise session	No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly.

Primary Outcome Measures

Name	Time	Method
Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training	Baseline only	One exercise training session

Trial Locations

Locations (1)

Duke Medicine - Duke Molecular Physiology Institute; 🇺🇸 Durham, North Carolina, United States