Back to resultsExercise Capacity and Recovery in Addison's Disease
Primary Purpose
Addison's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ergometry
ergometry
Sponsored by
About this trial
This is an interventional treatment trial for Addison's Disease focused on measuring exercise capacity, Addison's disease
Eligibility Criteria
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)
Sites / Locations
- University Medical Center Utrecht
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
hydrocortisone stress dosage
Arm Description
Outcomes
Primary Outcome Measures
exercise capacity
power in Watt and duration in minutes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01657123
Brief Title
Exercise Capacity and Recovery in Addison's Disease
Official Title
Effect of Hydrocortisone Stress Dose on Exercise Capacity and Post-exercise Recovery in Patients With Addison's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addison's Disease
Keywords
exercise capacity, Addison's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
hydrocortisone stress dosage
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ergometry
Intervention Description
ergometry measurements
Intervention Type
Other
Intervention Name(s)
ergometry
Intervention Description
Ergometry measurements
Primary Outcome Measure Information:
Title
exercise capacity
Description
power in Watt and duration in minutes
Time Frame
140 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisanne Smans, drs
Phone
0031616796646
Email
l.c.c.j.smans@umcutrecht.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Zelissen, dr
Phone
0031887550686
Email
p.m.j.zelissen@umcutrecht.nl
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisanne Smans, drs
Phone
0031616796646
Email
l.c.c.j.smans@umcutrecht.nl
First Name & Middle Initial & Last Name & Degree
Pierre Zelissen, dr
Phone
0031887550686
Email
p.m.j.zelissen@umcutrecht.nl
12. IPD Sharing Statement
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Exercise Capacity and Recovery in Addison's Disease
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