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Lower Body Muscle Pre-activation in Initial Orthostatic Hypotension

NCT03970551 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-04-29

No results posted yet for this study

Summary

This study is aimed primarily at providing a simple and effective form of treatment to reduce the symptoms of Initial Orthostatic Hypotension (IOH) and prevent syncope. We will first characterize the physiology of IOH, and then we will study four sit-to-stand maneuvers, each with a different stress tests to identify the role of sympathetic activity vs. simple muscle contraction in IOH. Then we will complete an additional two sit-to-stands with interventions designed to decrease the blood pressure drop (and hopefully symptoms) with initial stand. These consist of physical counter maneuvers, which may be a possible treatment that can be used to mitigate the drop in blood pressure (BP) seen in IOH during a stand and relieve presyncope symptoms.

Conditions

  • Orthostatic Intolerance
  • Syncope
  • Fainting
  • Presyncope

Interventions

OTHER

Physical Counter-maneuver

Physical counter-maneuver targeted at minimizing the large drop in BP seen in IOH patients.

OTHER

Stress Test

Stress test involving submerging your hand in ice water or performing mental arithmetic to increase sympathetic activity.

OTHER

Functional Electrical Stimulation

A mild electrical stimulus to passively induce a leg muscle contraction with minimal sympathetic activation.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Satish R Raj, MD, MSCI · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03970551 on ClinicalTrials.gov