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

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ClinicalTrials.gov Identifier: NCT02518724
Recruitment Status : Unknown
Verified December 2015 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Physical Performance Rhabdomyolysis Procedure: RIPC intervention exposure Procedure: placebo intervention exposure Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Remote Ischemic Preconditioning (RIPC) on Physical Performance and Exertional Rhabdomyolysis
Study Start Date : January 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.




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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518724


Contacts
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Contact: Ofir Frenkel, M.D +972529243399 Ofir.Frenkel@sheba.health.gov.il

Locations
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Israel
Sheba medical center
Tel-Hashomer, Ramat- Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Ofir Frenkel, M.D Sheba Medical Center

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02518724     History of Changes
Other Study ID Numbers: SHEBA-15-2139-OF-CTIL
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Rhabdomyolysis
Muscular Diseases
Musculoskeletal Diseases