Heart Rate Sensing and Response in Persons With Anorexia Nervosa

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.

Study Overview

• Status: Completed
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Behavioral: One hour supervised exercise session

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Medicine - Duke Molecular Physiology Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anorexia Nervosa (AN); Diagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months.	Behavioral: One hour supervised exercise session; 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.
Experimental: Matched Controls; 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; 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.
Experimental: Healthy Controls; No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly.	Behavioral: One hour supervised exercise session; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Nancy L Zucker, PhD, Director, Duke Center for Eating Disorders

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Estimate): January 2, 2017
• Last Update Submitted That Met QC Criteria: December 30, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Anorexia Nervosa; Healthy Adults
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: Pro00064421