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Trial record 1 of 3 for:    interoceptive signals
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Heart Rate Sensing and Response in Persons With Anorexia Nervosa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02579018
First received: October 15, 2015
Last updated: December 30, 2016
Last verified: December 2016
  Purpose
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 Intervention
Anorexia Nervosa Behavioral: One hour supervised exercise session

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Heart Rate Sensing and Response in Persons With Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by Duke University:

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


Enrollment: 18
Study Start Date: March 2016
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02579018     History of Changes
Other Study ID Numbers: Pro00064421
Study First Received: October 15, 2015
Last Updated: December 30, 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

ClinicalTrials.gov processed this record on June 23, 2017