![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |
---|---|
First Received Date † | October 9, 2008 |
Last Updated Date | April 8, 2009 |
Start Date † | November 2008 |
Current Primary Outcome Measures † |
Maximal Oxygen Consumption Capacity (VO2 max) [ Time Frame: At the time of the actual intervention ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00770484 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
Heart rate in response to the intervention [ Time Frame: Day after intervention ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | Effect of Exercise in OI |
Official Title † | Effects of Exercise in Orthostatic Intolerance |
Brief Summary | 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:
|
Detailed Description |
|
Study Phase | |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Condition † |
|
Intervention † |
|
Study Arms / Comparison Groups | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|
Recruitment Information | |
Recruitment Status † | Recruiting |
Enrollment † | 20 |
Estimated Completion Date | November 2012 |
Estimated Primary Completion Date | November 2012 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
Gender | Both |
Ages | 18 Years to 65 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00770484 |
Responsible Party | Italo Biaggioni, M.D. Professor of Medicine and Pharmacology., Vanderbilt University |
Secondary IDs †† | |
Study Sponsor † | Vanderbilt University |
Collaborators †† | |
Investigators † | |
Information Provided By | Vanderbilt University |
Verification Date | April 2009 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |