ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    interoceptive signals
Previous Study | Return to List | Next Study

Heart Rate Sensing and Response in Persons With Anorexia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02579018
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Behavioral: One hour supervised exercise session Not Applicable

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Heart Rate Sensing and Response in Persons With Anorexia Nervosa
Study Start Date : March 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training [ Time Frame: Baseline only ]
    One exercise training session



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579018


Locations
United States, North Carolina
Duke Medicine - Duke Molecular Physiology Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Nancy L Zucker, PhD Director, Duke Center for Eating Disorders

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02579018     History of Changes
Other Study ID Numbers: Pro00064421
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016

Keywords provided by Duke University:
Anorexia Nervosa
Exercise
Healthy Adults
Physical Activity

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders