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Exercise Capacity and Recovery in Addison's Disease

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01657123
Enrollment
20
Registered
2012-08-03
Start date
2013-01-31
Completion date
2014-01-31
Last updated
2012-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addison's Disease

Keywords

exercise capacity, Addison's disease

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.

Interventions

ergometry measurements

Sponsors

UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
exercise capacity140 minutespower in Watt and duration in minutes

Countries

Netherlands

Contacts

Primary ContactLisanne Smans, drs
l.c.c.j.smans@umcutrecht.nl0031616796646
Backup ContactPierre Zelissen, dr
p.m.j.zelissen@umcutrecht.nl0031887550686

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026