Effect of Exercise in OI

NCT00770484 | Completed Results

• 1 other identifier: 080722
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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:

1. 1.To test the hypothesis that lowering heart rate response with propanolol will result in an increase in exercise capacity.
2. 2.To test the hypothesis that a single bout of exercise will result in an improvement in orthostatic tolerance the day after exercising.

Conditions

Orthostatic Intolerance; Postural Tachycardia Syndrome

Keywords

Exercise; Propanolol; Beta blockers

Outcome Measures

Primary Outcomes (1)

• Maximal Oxygen Consumption Capacity (VO2 Max)

  Over approximately 30 minutes, within 2 hours of receiving each intervention.

Study Arms (2)

Propranolol then placebo

EXPERIMENTAL

Active treatment

Drug: Propranolol then Placebo

Placebo then propranolol

PLACEBO COMPARATOR

Placebo Treatment

Drug: Placebo then Propranolol

Interventions

Propranolol then Placebo DRUG

Propanolol 20 mg, given orally within 1 hour prior to exercising

Also known as: Active

Propranolol then placebo

Placebo then Propranolol DRUG

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

Also known as: Inactive

Placebo then propranolol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 23283362 DERIVED

MeSH Terms

Conditions

Orthostatic Intolerance; Postural Orthostatic Tachycardia Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Italo Biaggioni, MD., Professor of Medicine and Pharmacology
• Organization: Vanderbilt University

italo.biaggioni@vanderbilt.edu

(615) 936-3420

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pharmacology

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 10, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 5, 2016
• Results First Posted: July 9, 2015

Record last verified: 2016-07

Locations

US (1)