N/A
N=12
Effect of Exercise in OI
Orthostatic Intolerance · Postural Tachycardia Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00770484 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Maximal Oxygen Consumption Capacity (VO2 Max) — 27.6; 24.5 mL/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Propranolol then Placebo (Drug); Placebo then Propranolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Oxygen Consumption Capacity (VO2 Max) |
27.6; 24.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00770484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.