Heart Rate Sensing and Response in Persons With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Heart Rate Sensing and Response in Persons With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579018
• Other study ID #: Pro00064421
• Status: Completed
• Phase: N/A
• First received: October 15, 2015
• Last updated: December 30, 2016
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Medicine - Duke Molecular Physiology Institute	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training	One exercise training session	Baseline only	No