Addison's DiseaseNCT01657123
Exercise Capacity and Recovery in Addison's Disease
A study testing ergometry in people with Addison's Disease, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Addison's Disease
- What is being tested?
- ergometry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Addison's disease
- 18-50 years
- stable glucocortiocid replacement therapy
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
Lisanne Smans, drs, 0031616796646, l.c.c.j.smans@umcutrecht.nl
Pierre Zelissen, dr, 0031887550686, p.m.j.zelissen@umcutrecht.nl
About this study
Official title: Effect of Hydrocortisone Stress Dose on Exercise Capacity and Post-exercise Recovery in Patients With Addison's Disease
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.
- Conditions
- Addison's Disease
- Being tested
- ergometry
- Keywords
- exercise capacity, Addison's disease
- Medical subject headings
- Addison Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergometryOther
ergometry measurements
ergometryOther
Ergometry measurements
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Other: ergometry |
| hydrocortisone stress dosage | Experimental | Not described Receives: Other: ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
power in Watt and duration in minutes
Measured: 140 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addison's DiseaseStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Smans, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657123
- Sponsor's protocol ID
- 33088
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 3 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrocortisone Stress Dose on Exercise Capacity and Post-exercise Recovery in Patients With Addison's Disease
- ClinicalTrials.gov ID
- NCT01657123
- Acronym / sponsor ID
- 33088
- Conditions
- Addison's Disease
- Keywords
- exercise capacity, Addison's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: ergometry |
| hydrocortisone stress dosage | Experimental | Other: ergometry |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Addison's disease
- 18-50 years
- stable glucocortiocid replacement therapy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ergometryergometry measurements | Other | placebo |
| ergometryErgometry measurements | Other | hydrocortisone stress dosage |
Primary outcome
exercise capacity
Time frame: 140 minutes
power in Watt and duration in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ergometry in people with Addison's Disease, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisanne Smans, drs (0031616796646, l.c.c.j.smans@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise capacity (time frame: 140 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2012.