Heart Rate Sensing and Response in Persons With Anorexia Nervosa

NCT02579018 | Completed

• 1 other identifier: Pro00064421
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa; Exercise; Healthy Adults; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training

  One exercise training session

  Baseline only

Study Arms (3)

Anorexia Nervosa (AN)

EXPERIMENTAL

Diagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months.

Behavioral: One hour supervised exercise session

Matched Controls

EXPERIMENTAL

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

Healthy Controls

EXPERIMENTAL

No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly.

Behavioral: One hour supervised exercise session

Interventions

One hour supervised exercise session BEHAVIORAL

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.

Anorexia Nervosa (AN); Healthy Controls; Matched Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• BMI 25 kg/m2 or less
• Diagnosis of anorexia spectrum disorder
• Medications: Stable use of all medications ≥ three months
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Medicine - Duke Molecular Physiology Institute

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Anorexia Nervosa; Motor Activity

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Behavior

Study Officials

• Nancy L Zucker, PhD

  Director, Duke Center for Eating Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 2, 2017

Record last verified: 2016-12

Locations

US (1)