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Status unknownNCT01657123Updated Aug 3, 2012

Exercise Capacity and Recovery in Addison's Disease

An interventional study of ergometry and ergometry in Addison's Disease, sponsored by UMC Utrecht. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-08-03.

Sponsored by UMC Utrecht · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Addison's Disease

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Keywords

  • exercise capacity
  • Addison's disease
03

In context

Addison Disease

30 studies on the registry are indexed under Addison Disease; 8 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 19 interventional studies indexed under Addison Disease.

Browse Addison Disease studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Addison's disease
  • 18-50 years
  • stable glucocortiocid replacement therapy

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Placebo comparator
    placebo

    Other: ergometry

  • Experimental
    hydrocortisone stress dosage

    Other: ergometry

Interventions

  • Otherergometry

    ergometry measurements

  • Otherergometry

    Ergometry measurements

06

What researchers measure

Primary outcomes

  1. exercise capacity

    power in Watt and duration in minutes

    Time frame: 140 minutes

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01657123
Lead sponsor
UMC Utrecht
Responsible party
Smans (drs, UMC Utrecht) — Principal investigator
First posted
Aug 3, 2012
Start date
Jan 2013
Primary completion
Jan 2014 (estimated)
Completion
Jan 2014 (estimated)
Last update
Aug 3, 2012

Study contacts

Lisanne Smans, drs
Contact
l.c.c.j.smans@umcutrecht.nl
0031616796646
Pierre Zelissen, dr
Contact
p.m.j.zelissen@umcutrecht.nl
0031887550686

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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