Effect of Exercise in OI

Status Completed

Clinical Trial 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:

1. To test the hypothesis that lowering heart rate response with propanolol will result in an increase in exercise capacity.

2. To test the hypothesis that a single bout of exercise will result in an improvement in orthostatic tolerance the day after exercising.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Orthostatic Intolerance
Postural Orthostatic Tachycardia Syndrome
Postural Tachycardia Syndrome
Tachycardia

Clinical Trial Details

NCT number	NCT00770484
Study type	Interventional
Source	Vanderbilt University
Contact
Status	Completed
Phase	N/A
Start date	November 2008
Completion date	May 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03124355` - Vagal Stimulation in POTS	Phase 1
Recruiting	`NCT04310644` - Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry
Completed	`NCT03253120` - Alterations of Attention in POTS Depending on Body Position and Hydration	N/A
Completed	`NCT03919773` - IVIG (Gamunex-C) Treatment Study for POTS Subjects	Phase 1/Phase 2
Active, not recruiting	`NCT01988883` - Modafinil and Cognitive Function in POTS	Early Phase 1
Active, not recruiting	`NCT01000350` - Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)	N/A
Recruiting	`NCT00409435` - A Study of Pyridostigmine in Postural Tachycardia Syndrome	Phase 2
Completed	`NCT00581022` - Objective Sleep Disturbances in Orthostatic Intolerance
Terminated	`NCT00748228` - Dopamine in Orthostatic Tolerance	N/A
Active, not recruiting	`NCT05630040` - VNS for Long-COVID-19	N/A
Recruiting	`NCT04632134` - Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Postural Orthostatic Tachycardia Syndrome (POTS)	N/A
Completed	`NCT00685919` - Peripheral Dopamine in Postural Tachycardia Syndrome	Phase 2/Phase 3
Completed	`NCT00061009` - Hypnosis in Autonomic Function	N/A
Recruiting	`NCT05618054` - Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?	N/A
Completed	`NCT01366963` - Cognitive Dysfunction in Postural Tachycardia Syndrome	N/A
Recruiting	`NCT05107635` - Inappropriate Sinus Tachycardia Registry
Terminated	`NCT02154009` - Clinical Autonomic Disorders: A Training Protocol
Completed	`NCT03602482` - Standing Cognition and Co-morbidities of POTS Evaluation	N/A
Completed	`NCT02167412` - EEG Characteristics in Youth POTS and/or Syncope
Active, not recruiting	`NCT00692471` - Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.