Anorexia NervosaNCT02579018
Heart Rate Sensing and Response in Persons With Anorexia Nervosa
A study testing One hour supervised exercise session in people with Anorexia Nervosa, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- One hour supervised exercise session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Duke Medicine - Duke Molecular Physiology Institute
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- One hour supervised exercise session
- Keywords
- Anorexia Nervosa, Exercise, Healthy Adults, Physical Activity
- Medical subject headings
- Anorexia Nervosa, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One hour supervised exercise sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa (AN) | Experimental | Diagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months. Receives: Behavioral: One hour supervised exercise session |
| Matched Controls | Experimental | 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. Receives: Behavioral: One hour supervised exercise session |
| Healthy Controls | Experimental | No diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly. Receives: Behavioral: One hour supervised exercise session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training
One exercise training session
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy L Zucker, PhD, Principal investigator, Director, Duke Center for Eating Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579018
- Sponsor's protocol ID
- Pro00064421
- Status last verified
- Dec 2016
- First submitted
- 15 Oct 2015
- Last updated
- 2 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Sensing and Response in Persons With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02579018
- Acronym / sponsor ID
- Pro00064421
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Exercise, Healthy Adults, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa (AN) | Experimental | Behavioral: One hour supervised exercise sessionDiagnosis of anorexia spectrum disorder and stable use of all medications ≥ three months. |
| Matched Controls | Experimental | Behavioral: One hour supervised exercise sessionNo 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. |
| Healthy Controls | Experimental | Behavioral: One hour supervised exercise sessionNo diagnosis of anorexia spectrum disorder. Stable use of all medications ≥ three months. Do not exercise regularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One hour supervised exercise sessionAll 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. | Behavioural | Anorexia Nervosa (AN), Healthy Controls, Matched Controls |
Primary outcome
Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training
Time frame: Baseline only
One exercise training session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy L Zucker, PhD principal investigator
Director, Duke Center for Eating Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One hour supervised exercise session in people with Anorexia Nervosa, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training (time frame: Baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.