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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rhabdomyolysis; Physical Performance
• Intervention / Treatment: Procedure: RIPC intervention exposure; Procedure: placebo intervention exposure

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat- Gan
    • Tel-Hashomer, Ramat- Gan, Israel
      • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RIPC intervention 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 second series will be performed after RIPC intervention exposure at the beginning of every meeting.	Procedure: RIPC intervention 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
Placebo Comparator: false exopsure 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 second series will be performed after placebo intervention exposure at the beginning of every meeting.	Procedure: placebo intervention 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 10, 2015

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Rhabdomyolysis
• Other Study ID Numbers: SHEBA-15-2139-OF-CTIL