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Pre-activation Strategies for Orthostatic Hypotension (IOH Trial)

N/A

Waitlist Available

Led By Satish R Raj, MD, MSCI

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up < 5 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at a possible treatment for Initial Orthostatic Hypotension, which is a drop in blood pressure when standing up. The study will look at four different ways of standing up, with different stress tests, to see which is the most effective in reducing symptoms and preventing syncope (fainting).

Who is the study for?

This trial is for individuals aged 18-50 who can travel to the University of Calgary's research lab. It's open to those with initial orthostatic hypotension or healthy volunteers willing to consent. Pregnant individuals, those unable to stand or do leg exercises without help, or with sustained low blood pressure after standing for 3 minutes cannot join.

What is being tested?

The study tests treatments for sudden drops in blood pressure upon standing (IOH). Participants will perform sit-to-stand maneuvers under different conditions and stress tests to see if muscle contractions before standing can prevent dizziness and fainting associated with IOH.

What are the potential side effects?

Possible side effects may include discomfort from electrical stimulation during functional electrical stimulation therapy, fatigue from physical counter-maneuvers, and typical reactions like mild pain or bruising at the site of intervention.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ < 5 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~< 5 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and < 5 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Cerebral Blood Flow Velocity (CBFV)

Differences in Vanderbilt Orthostatic Symptoms Score (VOSS) Symptom Rating

Nadir SBP

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Supine Knee RaisesExperimental Treatment1 Intervention

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

Group II: Serial 7's Stress TestExperimental Treatment1 Intervention

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

Group III: Leg CrossingExperimental Treatment1 Intervention

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

Group IV: Functional Electrical StimulationExperimental Treatment1 Intervention

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

Group V: Cold Pressor TestExperimental Treatment1 Intervention

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

Group VI: No Physical InterventionActive Control1 Intervention

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

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