Exercise Capacity and Recovery in Addison's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01657123
Recruitment Status : Unknown
Verified August 2012 by Smans, UMC Utrecht.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Information provided by (Responsible Party):
Smans, UMC Utrecht

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Addison's Disease Other: ergometry Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Hydrocortisone Stress Dose on Exercise Capacity and Post-exercise Recovery in Patients With Addison's Disease
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Arm Intervention/treatment
Placebo Comparator: placebo Other: ergometry
ergometry measurements

Experimental: hydrocortisone stress dosage Other: ergometry
Ergometry measurements

Primary Outcome Measures :
  1. exercise capacity [ Time Frame: 140 minutes ]
    power in Watt and duration in minutes

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01657123

Contact: Lisanne Smans, drs 0031616796646
Contact: Pierre Zelissen, dr 0031887550686

University Medical Center Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Lisanne Smans, drs    0031616796646   
Contact: Pierre Zelissen, dr    0031887550686   
Sponsors and Collaborators
UMC Utrecht

Responsible Party: Smans, drs, UMC Utrecht Identifier: NCT01657123     History of Changes
Other Study ID Numbers: 33088
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012

Keywords provided by Smans, UMC Utrecht:
exercise capacity
Addison's disease

Additional relevant MeSH terms:
Addison Disease
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Anti-Inflammatory Agents