Heart Rate Sensing and Response in Persons With Anorexia Nervosa

NCT ID: NCT02579018

Last Updated: 2017-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Anorexia Nervosa (AN)

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

Group Type EXPERIMENTAL

One hour supervised exercise session

Intervention Type 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.

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.

Group Type EXPERIMENTAL

One hour supervised exercise session

Intervention Type 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.

Healthy Controls

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

Group Type EXPERIMENTAL

One hour supervised exercise session

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy L Zucker, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Duke Center for Eating Disorders

Locations

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Duke Medicine - Duke Molecular Physiology Institute

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00064421

Identifier Type: -

Identifier Source: org_study_id

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