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The Effect of Remote Ischemic Preconditioning on Physical Performance and Exertional Rhabdomyolysis

Primary Purpose

Physical Performance, Rhabdomyolysis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
RIPC intervention exposure
placebo intervention exposure
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Physical Performance

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 18-30
  • healthy civilians volunteers
  • with no background illnesses
  • above average fitness

Exclusion Criteria:

  • known chronic medical illness
  • routine medication usage
  • history of rhabdomyolysis
  • the physician decision

Sites / Locations

  • Sheba medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RIPC intervention group

false exopsure group

Arm Description

The experiment protocol consist 2 series (with a month between them), both series include the described 3 days: Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol). the second series will be performed after RIPC intervention exposure at the beginning of every meeting.

The experiment protocol consist 2 series (with a month between them), both series include the described 3 days: Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol). the second series will be performed after placebo intervention exposure at the beginning of every meeting.

Outcomes

Primary Outcome Measures

creatine phosphokinase (CPK)
CPK is a marker for muscle damage assessed in blood test. blood sample will be taken before and after step test, anaerobic test and time to exhaustion test.

Secondary Outcome Measures

oxygen consumption (VO2)
VO2 will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test and time to exhaustion test
heart rate variability (HRV)
HRV will be measured using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch) at rest for 10 min, before and after RIPC. data will be analysed by an expert.
lactic acid
lactic acid level is assessed from blood drop (finger sting), will be taken before and after every test. lactic acid is a marker for anaerobic effort evaluating.
blood count
blood counts are done to monitor overall health and to confirm a diagnosis of some medical conditions.
apolipoprotein A1 (APO-A1) levels
APO-A1 is measured in blood chemistry as a marker for cholesterol.
renal function (composite)
renal function (in order or not) will be evaluated from two markers measured in blood sample (chemistry): creatinine and urea.
inflammation (composite)
C-reactive protein (CRP) and blood sedimentation rate (assessed from blood sample) are indicators for inflammation.
heart rate
HR will be monitored during the physical tests using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).

Full Information

First Posted
July 13, 2015
Last Updated
December 23, 2015
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02518724
Brief Title
The Effect of Remote Ischemic Preconditioning on Physical Performance and Exertional Rhabdomyolysis
Official Title
The Effect of Remote Ischemic Preconditioning (RIPC) on Physical Performance and Exertional Rhabdomyolysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In order to examine the effect of RIPC on skeleton muscle exertional damage and on aerobic and anaerobic physical performances, 30 healthy volunteers will undergo a series of different physical tests twice; once without intervention and a second time with RIPC intervention or placebo (false) intervention.
Detailed Description
30 healthy civilians volunteers will be recruited and divided randomly into 2 groups: RIPC group and control group. The experiment protocol consist 2 series (with a month between them), both series include the described 3 days: Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol). The first series will be performed without applying any intervention and is considered as baseline measurements for both groups. the second series will be performed as follows: a. RIPC group: applying RIPC exposure (placing a sphygmomanometer on the non-dominant hand and applying pressure of 200 mmHg for 5 min followed by 5 min without pressure X 4 repeats) at the beginning of every meeting. b. control group: with placebo (false) exposure (placing a sphygmomanometer on the non-dominant hand and applying pressure of 100 mmHg for 5 min followed by 5 min without pressure X 4 repeats) at the beginning of every meeting. Blood ample, lactic acid and urine sample will be tested at the beginning and end of every meeting (testing for muscle, skeleton and kidney function markers).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Performance, Rhabdomyolysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPC intervention group
Arm Type
Active Comparator
Arm Description
The experiment protocol consist 2 series (with a month between them), both series include the described 3 days: Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol). the second series will be performed after RIPC intervention exposure at the beginning of every meeting.
Arm Title
false exopsure group
Arm Type
Placebo Comparator
Arm Description
The experiment protocol consist 2 series (with a month between them), both series include the described 3 days: Day 1 - anthropometry measurements and VO2max test (BRUCE protocol). Day 2 - steps test (heled protocol). Day 3 - anaerobic test (wingate protocol), 1 hour rest and time to exhaustion test (heled protocol). the second series will be performed after placebo intervention exposure at the beginning of every meeting.
Intervention Type
Procedure
Intervention Name(s)
RIPC intervention exposure
Intervention Description
placing a sphygmomanometer on the non-dominant hand and applying pressure of 200 mmHg for 5 min followed by 5 min without pressure X 4 repeats
Intervention Type
Procedure
Intervention Name(s)
placebo intervention exposure
Intervention Description
placing a sphygmomanometer on the non-dominant hand and applying pressure of 100 mmHg for 5 min followed by 5 min without pressure X 4 repeats.
Primary Outcome Measure Information:
Title
creatine phosphokinase (CPK)
Description
CPK is a marker for muscle damage assessed in blood test. blood sample will be taken before and after step test, anaerobic test and time to exhaustion test.
Time Frame
6 experiment days for each participant
Secondary Outcome Measure Information:
Title
oxygen consumption (VO2)
Description
VO2 will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test and time to exhaustion test
Time Frame
6 experiment days for each participant
Title
heart rate variability (HRV)
Description
HRV will be measured using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch) at rest for 10 min, before and after RIPC. data will be analysed by an expert.
Time Frame
6 experiment days for each participant
Title
lactic acid
Description
lactic acid level is assessed from blood drop (finger sting), will be taken before and after every test. lactic acid is a marker for anaerobic effort evaluating.
Time Frame
6 experiment days for each participant
Title
blood count
Description
blood counts are done to monitor overall health and to confirm a diagnosis of some medical conditions.
Time Frame
6 experiment days for each participant
Title
apolipoprotein A1 (APO-A1) levels
Description
APO-A1 is measured in blood chemistry as a marker for cholesterol.
Time Frame
6 experiment days for each participant
Title
renal function (composite)
Description
renal function (in order or not) will be evaluated from two markers measured in blood sample (chemistry): creatinine and urea.
Time Frame
6 experiment days for each participant
Title
inflammation (composite)
Description
C-reactive protein (CRP) and blood sedimentation rate (assessed from blood sample) are indicators for inflammation.
Time Frame
6 experiment days for each participant
Title
heart rate
Description
HR will be monitored during the physical tests using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Time Frame
6 experiment days for each participant

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 18-30 healthy civilians volunteers with no background illnesses above average fitness Exclusion Criteria: known chronic medical illness routine medication usage history of rhabdomyolysis the physician decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ofir Frenkel, M.D
Phone
+972529243399
Email
Ofir.Frenkel@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofir Frenkel, M.D
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel-Hashomer
State/Province
Ramat- Gan
Country
Israel

12. IPD Sharing Statement

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