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

Physical Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02518724
• Other study ID #: SHEBA-15-2139-OF-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: July 13, 2015
• Last updated: December 23, 2015
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Email: Ofir.Frenkel[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Physical Performance
• Rhabdomyolysis

Intervention

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 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.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	apolipoprotein A1 (APO-A1) levels	APO-A1 is measured in blood chemistry as a marker for cholesterol.	6 experiment days for each participant	No
Secondary	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	No
Secondary	inflammation (composite)	C-reactive protein (CRP) and blood sedimentation rate (assessed from blood sample) are indicators for inflammation.	6 experiment days for each participant	No
Secondary	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	Yes