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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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).

Sponsor: Sheba Medical Center

Current Primary Outcome: creatine phosphokinase (CPK) [ Time Frame: 6 experiment days for each participant ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• oxygen consumption (VO2) [ Time Frame: 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) [ Time Frame: 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.
• lactic acid [ Time Frame: 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.
• blood count [ Time Frame: 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 [ Time Frame: 6 experiment days for each participant ]
  APO-A1 is measured in blood chemistry as a marker for cholesterol.
• renal function (composite) [ Time Frame: 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) [ Time Frame: 6 experiment days for each participant ]
  C-reactive protein (CRP) and blood sedimentation rate (assessed from blood sample) are indicators for inflammation.
• heart rate [ Time Frame: 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).

Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: July 13, 2015
Date Started: January 2016
Date Completion: December 2016
Last Updated: December 23, 2015
Last Verified: December 2015