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

Not Applicable

• Conditions: Physical Performance; Rhabdomyolysis
• Interventions: Procedure: RIPC intervention exposure; Procedure: placebo intervention exposure

• Registration Number: NCT02518724
• Lead Sponsor: Sheba Medical Center

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).

Study Timeline

• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24
• Study Start: 2016-01
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC intervention group	RIPC intervention exposure	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.
false exopsure group	placebo intervention exposure	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.

Primary Outcome Measures

Name	Time	Method
creatine phosphokinase (CPK)	6 experiment days for each participant	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

Name	Time	Method
lactic acid	6 experiment days for each participant	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.
oxygen consumption (VO2)	6 experiment days for each participant	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)	6 experiment days for each participant	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.
blood count	6 experiment days for each participant	blood counts are done to monitor overall health and to confirm a diagnosis of some medical conditions.
apolipoprotein A1 (APO-A1) levels	6 experiment days for each participant	APO-A1 is measured in blood chemistry as a marker for cholesterol.
heart rate	6 experiment days for each participant	HR will be monitored during the physical tests using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
renal function (composite)	6 experiment days for each participant	renal function (in order or not) will be evaluated from two markers measured in blood sample (chemistry): creatinine and urea.
inflammation (composite)	6 experiment days for each participant	C-reactive protein (CRP) and blood sedimentation rate (assessed from blood sample) are indicators for inflammation.

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Tel-Hashomer, Ramat- Gan, Israel