- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164618
The Biology of Chronic Preconditioning: Genomic and Physiologic Mechanisms of Response
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years,
- Informed consent
Exclusion Criteria:
- Contraindication to exercise,
- Vigorous aerobic/anaerobic exercise in duration of ≥15 minutes during the 21 days prior to commencement of the study, or either of the RIPC or exercise protocol arms,
- Overt viral or bacterial infection in the 10 days prior to commencement of the study, or during either of the RIPC or exercise protocol arms,
- Alcohol and/or caffeine consumption in the 10 days prior to, or at any time during the study period
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
The subjects in this arm will begin on the daily remote ischemic preconditioning (RIPC) protocol for 10 days.
After a 21 day washout period they will then crossover to 10 days of daily exercise.
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RIPC will be induced using a standard blood pressure cuff and hand anaeroid sphygmomanometer, on the right arm.
The subject will be seated, the blood pressure cuff placed on the arm and inflated to a pressure of 200mmHg for 5 minutes (ischemia).
The cuff will then be deflated for 5 minutes (reperfusion) completing one cycle of ischemia reperfusion.
A total of 4 inflation and deflation cycles will be applied.
This protocol of RIPC will be applied daily, for 10 consecutive days.
Subjects will then undergo exercise daily, for 10 consecutive days.
A chronic high-intensity interval exercise training protocol standardized to subjects' aerobic power (VO¬2max) will be used.
Each exercise session will consist of a 5 min warm-up period followed by 4 sets of 2 min high intensity intervals interspersed with 3 min recovery periods.
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Experimental: Group 2
The subjects in this arm will begin on the exercise protocol for 10 days.
After a 21 day washout period they will then crossover to 10 days of daily remote ischemic preconditioning (RIPC).
|
RIPC will be induced using a standard blood pressure cuff and hand anaeroid sphygmomanometer, on the right arm.
The subject will be seated, the blood pressure cuff placed on the arm and inflated to a pressure of 200mmHg for 5 minutes (ischemia).
The cuff will then be deflated for 5 minutes (reperfusion) completing one cycle of ischemia reperfusion.
A total of 4 inflation and deflation cycles will be applied.
This protocol of RIPC will be applied daily, for 10 consecutive days.
Subjects will then undergo exercise daily, for 10 consecutive days.
A chronic high-intensity interval exercise training protocol standardized to subjects' aerobic power (VO¬2max) will be used.
Each exercise session will consist of a 5 min warm-up period followed by 4 sets of 2 min high intensity intervals interspersed with 3 min recovery periods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ischemia-reperfusion injury tolerance
Time Frame: Day 1 of the Excercise intervention
|
This will be done to assess whether chronic preconditioning in humans generates a circulating effector(s) responsible for the generation of cardioprotection in our mouse model of ischemia-reperfusion injury. This measure will be compared over time within groups and between groups. |
Day 1 of the Excercise intervention
|
Ischemia-reperfusion injury tolerance
Time Frame: Day 1 of the RIPC intervention
|
This will be done to assess whether chronic preconditioning in humans generates a circulating effector(s) responsible for the generation of cardioprotection in our mouse model of ischemia-reperfusion injury. This measure will be compared over time within groups and between groups. |
Day 1 of the RIPC intervention
|
Ischemia-reperfusion injury tolerance
Time Frame: Day 2 of the Excercise intervention
|
This will be done to assess whether chronic preconditioning in humans generates a circulating effector(s) responsible for the generation of cardioprotection in our mouse model of ischemia-reperfusion injury. This measure will be compared over time within groups and between groups. |
Day 2 of the Excercise intervention
|
Ischemia-reperfusion injury tolerance
Time Frame: Day 2 of the RIPC intervention
|
This will be done to assess whether chronic preconditioning in humans generates a circulating effector(s) responsible for the generation of cardioprotection in our mouse model of ischemia-reperfusion injury. This measure will be compared over time within groups and between groups. |
Day 2 of the RIPC intervention
|
Ischemia-reperfusion injury tolerance
Time Frame: Day 10 of the Excercise intervention
|
This will be done to assess whether chronic preconditioning in humans generates a circulating effector(s) responsible for the generation of cardioprotection in our mouse model of ischemia-reperfusion injury. This measure will be compared over time within groups and between groups. |
Day 10 of the Excercise intervention
|
Ischemia-reperfusion injury tolerance
Time Frame: Day 10 of the RIPC intervention
|
This will be done to assess whether chronic preconditioning in humans generates a circulating effector(s) responsible for the generation of cardioprotection in our mouse model of ischemia-reperfusion injury. This measure will be compared over time within groups and between groups. |
Day 10 of the RIPC intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in skeletal muscle metabolic parameters metabolism as measured by 31P-MRS and BOLD fMRI over time within groups and between groups
Time Frame: Days 1, 2 and 10 days of each intervention (RIPC and Excercise)
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Days 1, 2 and 10 days of each intervention (RIPC and Excercise)
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Neutrophil Function - adhesion, phagocytotic index, and superoxide production over time within groups and between groups
Time Frame: Days 1, 2 and 10 of each intervention (RIPC and Excercise)
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Days 1, 2 and 10 of each intervention (RIPC and Excercise)
|
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Neutrophil Gene Expression over time within groups and between groups
Time Frame: Days 1, 2 and 10 of each intervention (RIPC and Excercise)
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Days 1, 2 and 10 of each intervention (RIPC and Excercise)
|
|
Ischemia-reperfusion injury tolerance
Time Frame: Days 1, 2 and 10 of each intervention (RIPC and Excercise)
|
We will assess whether chronic preconditioning in humans generates a circulating effector(s) responsible for the generation of cardioprotection in our mouse model of ischemia-reperfusion injury.
|
Days 1, 2 and 10 of each intervention (RIPC and Excercise)
|
Exercise Capacity (VO2max) over time within groups and between groups
Time Frame: Day 10 of each intervention (RIPC and Exercise)
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Day 10 of each intervention (RIPC and Exercise)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Redington, MD, The Hospital for Sick Children, Toronto Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000015862
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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