The Biology of Chronic Preconditioning: Genomic and Physiologic Mechanisms of Response

NCT01164618 | Unknown Phase 2

• 1 other identifier: 1000015862
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of repeated RIPC and exercise, on exercise performance, skeletal muscle responses and circulating cellular and humoral biology in humans

Conditions

Ischemic Preconditioning

Keywords

pediatrics; Remote ischemic preconditioning

Outcome Measures

Primary Outcomes (6)

• Ischemia-reperfusion injury tolerance

  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

  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

  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

  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

  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

  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 Outcomes (5)

• Change in skeletal muscle metabolic parameters metabolism as measured by 31P-MRS and BOLD fMRI over time within groups and between groups

  Days 1, 2 and 10 days of each intervention (RIPC and Excercise)

• Neutrophil Function - adhesion, phagocytotic index, and superoxide production over time within groups and between groups

  Days 1, 2 and 10 of each intervention (RIPC and Excercise)

• Neutrophil Gene Expression over time within groups and between groups

  Days 1, 2 and 10 of each intervention (RIPC and Excercise)

• Ischemia-reperfusion injury tolerance

  Days 1, 2 and 10 of each intervention (RIPC and Excercise)

• Exercise Capacity (VO2max) over time within groups and between groups

  Day 10 of each intervention (RIPC and Exercise)

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Procedure: Remote ischemic preconditioning (RIPC); Other: Exercise

Group 2

EXPERIMENTAL

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).

Procedure: Remote ischemic preconditioning (RIPC); Other: Exercise

Interventions

Remote ischemic preconditioning (RIPC) PROCEDURE

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.

Group 1; Group 2

Exercise OTHER

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years,
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Andrew Redington, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Heart Centre-Cardiology Division

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

CA (1)