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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
IOH Trial 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.Check my eligibility
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.See study design
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.
IOH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ < 5 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~< 5 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Magnitude of change in SBP from sitting to stand with a physical intervention
Secondary outcome measures
Cerebral Blood Flow Velocity (CBFV)
Differences in Vanderbilt Orthostatic Symptoms Score (VOSS) Symptom Rating
Nadir SBP
+1 moreIOH 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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Who is running the clinical trial?
University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,670 Total Patients Enrolled
1 Trials studying Orthostatic Intolerance
26 Patients Enrolled for Orthostatic Intolerance
Satish R Raj, MD, MSCIPrincipal InvestigatorUniversity of Calgary
4 Previous Clinical Trials
223 Total Patients Enrolled
1 Trials studying Orthostatic Intolerance
26 Patients Enrolled for Orthostatic Intolerance
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need help to stand up or do leg exercises.You have low blood pressure when you stand up, or you are a healthy person volunteering for the study.You feel dizzy or lightheaded when you stand up for more than 3 minutes.You are between 18 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Serial 7's Stress Test
- Group 2: Supine Knee Raises
- Group 3: Leg Crossing
- Group 4: No Physical Intervention
- Group 5: Functional Electrical Stimulation
- Group 6: Cold Pressor Test
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the prerequisites to partake in this clinical trial?
"To be considered, applicants must suffer from syncope and be within the 18 to 50 age range. The total number of participants needed is 64 people."
Answered by AI
Does the age cutoff for eligibility in this experiment cap at 40 years of age?
"Enrolment for this medical trial is open to adults from 18-50 years old."
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Is this research experiment allowing for patient participation at present?
"As indicated on clinicaltrials.gov, this study is no longer actively enrolling participants; it was initially posted July 1st 2019 and last updated April 28th 2021. Nonetheless, 139 other trials are presently open for enrollment."
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