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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02518724
Enrollment
30
Registered
2015-08-10
Start date
2016-01-31
Completion date
2016-12-31
Last updated
2015-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Performance, 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 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).

Interventions

PROCEDURERIPC 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

PROCEDUREplacebo 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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
creatine phosphokinase (CPK)6 experiment days for each participantCPK 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

MeasureTime frameDescription
heart rate variability (HRV)6 experiment days for each participantHRV 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 acid6 experiment days for each participantlactic 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 count6 experiment days for each participantblood counts are done to monitor overall health and to confirm a diagnosis of some medical conditions.
oxygen consumption (VO2)6 experiment days for each participantVO2 will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test and time to exhaustion test
renal function (composite)6 experiment days for each participantrenal 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 participantC-reactive protein (CRP) and blood sedimentation rate (assessed from blood sample) are indicators for inflammation.
heart rate6 experiment days for each participantHR will be monitored during the physical tests using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
apolipoprotein A1 (APO-A1) levels6 experiment days for each participantAPO-A1 is measured in blood chemistry as a marker for cholesterol.

Countries

Israel

Contacts

Primary ContactOfir Frenkel, M.D
Ofir.Frenkel@sheba.health.gov.il+972529243399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026