Exercise Capacity and Recovery in Addison's Disease

NCT ID: NCT01657123

Last Updated: 2012-08-03

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

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Exposure to stress alters the activity of the adrenomedullary, adrenocortical and sympathetic nervous system, depending on the type and intensity of the stressor. Physical exercise represents a stress condition influencing many systems in the body. Given a workload of at least 70-85% of Vo2max, exercise is a potent stimulus of the hypothalamic-pituitary-adrenal (HPA)-axis. The increased endogenous cortisol secretion results in important metabolic and cardiovascular effects to maintain cellular and organ homeostasis. Patients with Addison's disease are not able to meet the increased demand of adrenal steroids in case of physical exercise, which may result in an impaired exercise capacity and a prolonged post-exercise recovery. We hypothesize that a hydrocortisone stress dose increases exercise capacity and improves post-exercise recovery in patients with Addison's disease.

Detailed Description

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Conditions

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Addison's Disease

Keywords

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exercise capacity Addison's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

ergometry

Intervention Type OTHER

ergometry measurements

hydrocortisone stress dosage

Group Type EXPERIMENTAL

ergometry

Intervention Type OTHER

Ergometry measurements

Interventions

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ergometry

ergometry measurements

Intervention Type OTHER

ergometry

Ergometry measurements

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Addison's disease
* 18-50 years
* stable glucocortiocid replacement therapy

Exclusion Criteria

* Presence of intercurrent (acute) infectious disease
* Mental impairment (major depressive, anxiety, panic, adjustment, bipolar, psychotic, posttraumatic or borderline personality disorder)
* Presence of the following chronic diseases: diabetes mellitus, chronic obstructive pulmonary disease, renal failure, chronic anaemia, malignancy, rheumatoid arthritis
* Presence of the following cardiovascular conditions: unstable angina pectoris, history of myocardial infarction, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic (severe) aortic stenosis, uncontrolled symptomatic heart failure, acute myocarditis or pericarditis, left main coronary stenosis, moderate stenotic valvular heart disease, tachyarrhythmias or bradyarrhythmias, hypertrophic cardiomyopathy and other forms of outflow tract obstruction, high-degree atrioventricular block
* History of pulmonary embolus or pulmonary infarction
* Known aortic aneurysm
* Severe hypertension (\>170/100 mm Hg)
* Medication that affects cardiovascular function (beta-blocker, calcium antagonist, ACE-inhibitors, aldosterone-antagonists)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Smans

drs

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Lisanne Smans, drs

Role: CONTACT

Phone: 0031616796646

Email: [email protected]

Pierre Zelissen, dr

Role: CONTACT

Phone: 0031887550686

Email: [email protected]

Facility Contacts

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Lisanne Smans, drs

Role: primary

Pierre Zelissen, dr

Role: backup

Other Identifiers

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33088

Identifier Type: -

Identifier Source: org_study_id