Effect of Exercise in OI
Primary Purpose
Orthostatic Intolerance, Postural Tachycardia Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propranolol then Placebo
Placebo then Propranolol
Sponsored by
About this trial
This is an interventional treatment trial for Orthostatic Intolerance focused on measuring Exercise, Propanolol, Beta blockers
Eligibility Criteria
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.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Propranolol then placebo
Placebo then propranolol
Arm Description
Active treatment
Placebo Treatment
Outcomes
Primary Outcome Measures
Maximal Oxygen Consumption Capacity (VO2 Max)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00770484
Brief Title
Effect of Exercise in OI
Official Title
Effects of Exercise in Orthostatic Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Intolerance, Postural Tachycardia Syndrome
Keywords
Exercise, Propanolol, Beta blockers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propranolol then placebo
Arm Type
Experimental
Arm Description
Active treatment
Arm Title
Placebo then propranolol
Arm Type
Placebo Comparator
Arm Description
Placebo Treatment
Intervention Type
Drug
Intervention Name(s)
Propranolol then Placebo
Other Intervention Name(s)
Active
Intervention Description
Propanolol 20 mg, given orally within 1 hour prior to exercising
Intervention Type
Drug
Intervention Name(s)
Placebo then Propranolol
Other Intervention Name(s)
Inactive
Intervention Description
Placebo, matching pill given orally within 1 hour prior to exercising
Primary Outcome Measure Information:
Title
Maximal Oxygen Consumption Capacity (VO2 Max)
Time Frame
Over approximately 30 minutes, within 2 hours of receiving each intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23283362
Citation
Gamboa A, Okamoto LE, Raj SR, Diedrich A, Shibao CA, Robertson D, Biaggioni I. Nitric oxide and regulation of heart rate in patients with postural tachycardia syndrome and healthy subjects. Hypertension. 2013 Feb;61(2):376-81. doi: 10.1161/HYPERTENSIONAHA.111.00203. Epub 2013 Jan 2.
Results Reference
derived
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Effect of Exercise in OI
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