Lower Body Muscle Pre-activation in Initial Orthostatic Hypotension

NCT03970551 | Unknown

• 1 other identifier: REB19-0792
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Initial Orthostatic Hypotension; IOH; Physical Counter-maneuver; Refractory Period; Active Stand; Muscle Tensing; Leg Crossing; Lower Body Muscle Tensing

Outcome Measures

Primary Outcomes (1)

• Magnitude of change in SBP from sitting to stand with a physical intervention

  The magnitude of change in SBP from sitting to stand when the participant performs muscle pre-activation before a stand compared to no intervention at all.

  < 5 minutes

Secondary Outcomes (4)

• Differences in Vanderbilt Orthostatic Symptoms Score (VOSS) Symptom Rating

  < 5 minutes

• Nadir SBP

  < 5 minutes

• Peak HR

  < 5 minutes

• Cerebral Blood Flow Velocity (CBFV)

  < 5 minutes

Study Arms (6)

No Physical Intervention

NO INTERVENTION

The participant will actively stand up from a seated position without performing any physical counter-maneuvers either prior to or following the stand.

Supine Knee Raises

EXPERIMENTAL

The participant will perform 30 seconds of raising their knees to their chest while sitting down before actively standing.

Other: Physical Counter-maneuver

Leg Crossing

EXPERIMENTAL

The participant will actively stand and then immediately cross their legs and tense their leg muscles for 60 seconds.

Other: Physical Counter-maneuver

Cold Pressor Test

EXPERIMENTAL

The participant will submerge their hands in ice water for approximately 45 seconds.

Other: Stress Test

Serial 7's Stress Test

EXPERIMENTAL

The participant will perform a mental arithmetic stress test for 30 seconds prior to standing.

Other: Stress Test

Functional Electrical Stimulation

EXPERIMENTAL

The participant will have their quadriceps passively contracted using mild electrical stimulation for approximately 30 seconds prior to standing.

Other: Functional Electrical Stimulation

Interventions

Physical Counter-maneuver OTHER

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

Leg Crossing; Supine Knee Raises

Stress Test OTHER

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

Also known as: Cold Pressor Test, Serial 7's Stress Test

Cold Pressor Test; Serial 7's Stress Test

Functional Electrical Stimulation OTHER

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

Functional Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Either have initial orthostatic hypotension or are a healthy volunteer
• years old
• Male or Female
• Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Research Testing Lab in the Teaching, Research \& Wellness Building at the University of Calgary, Calgary, AB
• Able and willing to provide informed consent

You may not qualify if:

• Inability to stand up or perform leg exercises without assistance
• Sustained orthostatic hypotension past 3 minutes of standing
• Pregnant

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

Related Publications (11)

• da Silva RM. Syncope: epidemiology, etiology, and prognosis. Front Physiol. 2014 Dec 8;5:471. doi: 10.3389/fphys.2014.00471. eCollection 2014.

  PMID: 25538626 BACKGROUND

• McJunkin B, Rose B, Amin O, Shah N, Sharma S, Modi S, Kemper S, Yousaf M. Detecting initial orthostatic hypotension: a novel approach. J Am Soc Hypertens. 2015 May;9(5):365-9. doi: 10.1016/j.jash.2015.02.006. Epub 2015 Feb 13.

  PMID: 25816712 BACKGROUND

• Eser I, Khorshid L, Gunes UY, Demir Y. The effect of different body positions on blood pressure. J Clin Nurs. 2007 Jan;16(1):137-40. doi: 10.1111/j.1365-2702.2005.01494.x.

  PMID: 17181675 BACKGROUND

• Wieling W, Krediet CT, van Dijk N, Linzer M, Tschakovsky ME. Initial orthostatic hypotension: review of a forgotten condition. Clin Sci (Lond). 2007 Feb;112(3):157-65. doi: 10.1042/CS20060091.

  PMID: 17199559 BACKGROUND

• Stewart JM, Clarke D. "He's dizzy when he stands up": an introduction to initial orthostatic hypotension. J Pediatr. 2011 Mar;158(3):499-504. doi: 10.1016/j.jpeds.2010.09.004. No abstract available.

  PMID: 20970148 BACKGROUND

• Stewart JM. Mechanisms of sympathetic regulation in orthostatic intolerance. J Appl Physiol (1985). 2012 Nov;113(10):1659-68. doi: 10.1152/japplphysiol.00266.2012. Epub 2012 Jun 7.

  PMID: 22678960 BACKGROUND

• Tschakovsky ME, Matusiak K, Vipond C, McVicar L. Lower limb-localized vascular phenomena explain initial orthostatic hypotension upon standing from squat. Am J Physiol Heart Circ Physiol. 2011 Nov;301(5):H2102-12. doi: 10.1152/ajpheart.00571.2011. Epub 2011 Aug 19.

  PMID: 21856921 BACKGROUND

• Wieling W, van Dijk N, Thijs RD, de Lange FJ, Krediet CT, Halliwill JR. Physical countermeasures to increase orthostatic tolerance. J Intern Med. 2015 Jan;277(1):69-82. doi: 10.1111/joim.12249. Epub 2014 May 5. No abstract available.

  PMID: 24697914 BACKGROUND

• Krediet CT, Go-Schon IK, Kim YS, Linzer M, Van Lieshout JJ, Wieling W. Management of initial orthostatic hypotension: lower body muscle tensing attenuates the transient arterial blood pressure decrease upon standing from squatting. Clin Sci (Lond). 2007 Nov;113(10):401-7. doi: 10.1042/CS20070064.

  PMID: 17561808 BACKGROUND

• van Twist DJL, Dinh T, Bouwmans EME, Kroon AA. Initial orthostatic hypotension among patients with unexplained syncope: An overlooked diagnosis? Int J Cardiol. 2018 Nov 15;271:269-273. doi: 10.1016/j.ijcard.2018.05.043.

  PMID: 30223355 BACKGROUND

• Sheikh NA, Phillips AA, Ranada S, Lloyd M, Kogut K, Bourne KM, Jorge JG, Lei LY, Sheldon RS, Exner DV, Runte M, Raj SR. Mitigating Initial Orthostatic Hypotension: Mechanistic Roles of Muscle Contraction Versus Sympathetic Activation. Hypertension. 2022 Mar;79(3):638-647. doi: 10.1161/HYPERTENSIONAHA.121.18580. Epub 2022 Jan 6.

  PMID: 34990207 DERIVED

MeSH Terms

Conditions

Orthostatic Intolerance; Syncope

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Satish R Raj, MD, MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be 6 stands that will involve standing from a sitting position and performing physical counter-maneuvers or a stress test either prior to or following the stand. The order of the interventions will be randomized. Both healthy participants and IOH patients will perform all stands.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 31, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)