- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00770484
Effect of Exercise in OI
Effects of Exercise in Orthostatic Intolerance
The main limitation patients with orthostatic intolerance (OI, or postural tachycardia syndrome, POTS) have to exercise is related to their increase in heart rate when standing. Main pharmacological treatment today is aimed at reducing heart rate with the use of betablockers (propanolol), this theoretically could also improve their exercise capacity; if their heart rate do not increase as much with the medication, they could exercise more. In addition, it has been suggested that in healthy volunteers subjected to head down tilt for 2 weeks (situation that produces a "simulated" transient POTS-like state) a single bout of intense exercise can improve orthostatic tolerance the day after exercising. The mechanisms involved in such response are not that clear but could be an increase in plasma volume already diminished in POTS patients. It seems likely that the same could be true for POTS patients.
The purpose of the present study are to pharmacologically improve the amount of exercise POTS patients can perform by reducing their baseline heart rate (specific aim 1) and to evaluate next day heart responses to an acute bout of intense exercise.
Therefore, the specific aims of this study are:
- To test the hypothesis that lowering heart rate response with propanolol will result in an increase in exercise capacity.
- To test the hypothesis that a single bout of exercise will result in an improvement in orthostatic tolerance the day after exercising.
Study Overview
Status
Intervention / Treatment
Detailed Description
- Subjects will be studied twice, once after receiving placebo and in a second occasion after receiving propanolol.
- An exercise capacity test with estimation of maximal oxygen consumption (VO2 max) will be done within 1 hour of receiving a pill containing placebo and that will be in appearance identical to the one for propanolol. This test will be conducted on a stationary bicycle and the effort will be gradually increased while expired air is measured during exhaustive physical work. The test will last approximately 30 minutes and be conducted in Vanderbilt's Clinical Trial Center.
- The day before and the day after the exercise test subjects will be asked to collect urine for 12 hours each time and to keep a record of how much liquid they ingest.
- Posture study tests (measurements of heart rate and blood pressure taken while lying down and at intervals for up to 30 minutes while standing) will be done the day before and the day after the exercise test.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meet diagnostic criteria of POTS (Raj, et al., 2005)
- Age between 18-65 years
- Male and female are eligible (although the majority of patients POTS are female).
- Able and willing to provide informed consent
Exclusion Criteria:
- Presence of medical conditions that can explain postural tachycardia (e.g., dehydration, medications)
- Pregnancy
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
- Patients who are bedridden or chair-ridden.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Propranolol then placebo
Active treatment
|
Propanolol 20 mg, given orally within 1 hour prior to exercising
Other Names:
|
Placebo Comparator: Placebo then propranolol
Placebo Treatment
|
Placebo, matching pill given orally within 1 hour prior to exercising
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximal Oxygen Consumption Capacity (VO2 Max)
Time Frame: Over approximately 30 minutes, within 2 hours of receiving each intervention.
|
Over approximately 30 minutes, within 2 hours of receiving each intervention.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Tachycardia
- Postural Orthostatic Tachycardia Syndrome
- Orthostatic Intolerance
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
Other Study ID Numbers
- 080722
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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