Exercise Capacity and Recovery in Addison's Disease

Addison's Disease Clinical Trial

Official title:

Effect of Hydrocortisone Stress Dose on Exercise Capacity and Post-exercise Recovery in Patients With Addison's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01657123
• Other study ID #: 33088
• Status: Not yet recruiting
• Phase: N/A
• First received: August 1, 2012
• Last updated: August 2, 2012
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2012
• Source: UMC Utrecht
• Contact: Lisanne Smans, drs
• Phone: 0031616796646
• Email: l.c.c.j.smans[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: The Netherlands: Julius Clinical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Addison Disease
• Addison's Disease

Intervention

Other:
• ergometry
ergometry measurements
• ergometry
Ergometry measurements

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity	power in Watt and duration in minutes	140 minutes	No