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Heart Rate Sensing and Response in Persons With Anorexia Nervosa

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Duke University

Status

Completed

Conditions

Anorexia Nervosa

Treatments

Behavioral: One hour supervised exercise session

Study type

Interventional

Funder types

Other

Identifiers

NCT02579018
Pro00064421

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

18 participants in 3 patient groups

Anorexia Nervosa (AN)
Experimental group
Description:
Diagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months.
Treatment:
Behavioral: One hour supervised exercise session
Matched Controls
Experimental group
Description:
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.
Treatment:
Behavioral: One hour supervised exercise session
Healthy Controls
Experimental group
Description:
No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly.
Treatment:
Behavioral: One hour supervised exercise session

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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