Clinical trial NCT02518724: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Performance
Rhabdomyolysis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-08-10
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: creatine phosphokinase (CPK)
timeFrame: 6 experiment days for each participant
Secondary outcomes:
measure: oxygen consumption (VO2)
timeFrame: 6 experiment days for each participant
measure: heart rate variability (HRV)
timeFrame: 6 experiment days for each participant
measure: lactic acid
timeFrame: 6 experiment days for each participant
measure: blood count
timeFrame: 6 experiment days for each participant
measure: apolipoprotein A1 (APO-A1) levels
timeFrame: 6 experiment days for each participant
measure: renal function (composite)
timeFrame: 6 experiment days for each participant
measure: inflammation (composite)
timeFrame: 6 experiment days for each participant
measure: heart rate
timeFrame: 6 experiment days for each participant
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References: