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OpenTrials
Completed

NCT Number: NCT02579018

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Medicine - Duke Molecular Physiology Institute

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2015
Registry last updated
Jan 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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