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Effect of Exercise in OI

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ClinicalTrials.gov Identifier: NCT00770484
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : July 9, 2015
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Orthostatic Intolerance
Postural Tachycardia Syndrome
Interventions Drug: Propranolol then Placebo
Drug: Placebo then Propranolol
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propranolol Then Placebo Placebo Then Propranolol
Hide Arm/Group Description

Active treatment

Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising

Placebo Treatment

Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising

Period Title: Overall Study
Started 8 4
Completed 7 4
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Propranolol Then Placebo Placebo Then Propranolol Total
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Active treatment

Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising

Placebo Treatment

Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising

Total of all reporting groups
Overall Number of Baseline Participants 8 4 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
4
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 4 participants 12 participants
31  (3) 32  (2) 32  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 4 participants 12 participants
Female
8
 100.0%
4
 100.0%
12
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 4 participants 12 participants
8 4 12
1.Primary Outcome
Title Maximal Oxygen Consumption Capacity (VO2 Max)
Hide Description [Not Specified]
Time Frame Over approximately 30 minutes, within 2 hours of receiving each intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propranolol Placebo
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Active treatment

Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising

Placebo Treatment

Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising

Overall Number of Participants Analyzed 11 11
Mean (Standard Error)
Unit of Measure: mL/kg/min
27.6  (1) 24.5  (0.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propranolol Then Placebo Placebo Then Propranolol
Hide Arm/Group Description

Active treatment

Propranolol then Placebo: Propanolol 20 mg, given orally within 1 hour prior to exercising

Placebo Treatment

Placebo then Propranolol: Placebo, matching pill given orally within 1 hour prior to exercising

All-Cause Mortality
Propranolol Then Placebo Placebo Then Propranolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Propranolol Then Placebo Placebo Then Propranolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propranolol Then Placebo Placebo Then Propranolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/4 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Italo Biaggioni, MD., Professor of Medicine and Pharmacology
Organization: Vanderbilt University
Phone: (615) 936-3420
Responsible Party: Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00770484     History of Changes
Other Study ID Numbers: 080722
First Submitted: October 9, 2008
First Posted: October 10, 2008
Results First Submitted: May 29, 2015
Results First Posted: July 9, 2015
Last Update Posted: August 5, 2016