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

NCT02518724 | Unknown

• 1 other identifier: SHEBA-15-2139-OF-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Performance; Rhabdomyolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• oxygen consumption (VO2)

  6 experiment days for each participant

• heart rate variability (HRV)

  6 experiment days for each participant

• lactic acid

  6 experiment days for each participant

• blood count

  6 experiment days for each participant

• apolipoprotein A1 (APO-A1) levels

  6 experiment days for each participant

Study Arms (2)

RIPC intervention group

ACTIVE COMPARATOR

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

false exopsure group

PLACEBO COMPARATOR

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

Interventions

RIPC intervention exposure PROCEDURE

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

RIPC intervention group

placebo intervention exposure PROCEDURE

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.

false exopsure group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-30
• healthy civilians volunteers
• with no background illnesses
• above average fitness

You may not qualify if:

• known chronic medical illness
• routine medication usage
• history of rhabdomyolysis
• the physician decision

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Location

MeSH Terms

Conditions

Rhabdomyolysis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Ofir Frenkel, M.D

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofir Frenkel, M.D

CONTACT

+972529243399; Ofir.Frenkel@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: August 10, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

IL (1)