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

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of Remote Ischemic Preconditioning (RIPC) on Physical Performance and Exertional Rhabdomyolysis

Conditions
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Physical Performance, Rhabdomyolysis

Intervention / Treatment
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* Procedure: RIPC intervention exposure
* Procedure: placebo intervention exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIPC intervention group<br>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. | Procedure: RIPC intervention exposure<br>* 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<br>|
| Placebo Comparator: false exopsure group<br>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. | Procedure: placebo intervention exposure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 experiment days for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen consumption (VO2) | VO2 will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test and time to exhaustion test | 6 experiment days for each participant | 
| 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. | 6 experiment days for each participant | 
| 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. | 6 experiment days for each participant | 
| blood count | blood counts are done to monitor overall health and to confirm a diagnosis of some medical conditions. | 6 experiment days for each participant | 
| apolipoprotein A1 (APO-A1) levels | APO-A1 is measured in blood chemistry as a marker for cholesterol. | 6 experiment days for each participant | 
| renal function (composite) | renal function (in order or not) will be evaluated from two markers measured in blood sample (chemistry): creatinine and urea. | 6 experiment days for each participant | 
| inflammation (composite) | C-reactive protein (CRP) and blood sedimentation rate (assessed from blood sample) are indicators for inflammation. | 6 experiment days for each participant | 
| heart rate | HR will be monitored during the physical tests using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch). | 6 experiment days for each participant |