Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

Not Applicable

• Conditions: Rhabdomyolysis
• Interventions: Other: physical tests

• Registration Number: NCT02498366
• Lead Sponsor: Sheba Medical Center

Brief Summary

In order to determine norm values for skeleton muscle disassembly due to physical exertion in healthy and trained population, and developing a prediction test for approval for rhabdomyolysis injuries to return to duty, 50 healthy subjects will undergo a series of different physical tests.

Detailed Description

50 healthy civilians volunteers will be recruited for this study. Each subject will undergo the physical tests: anthropometric measurements, wingate test, VO2max test, step test and running on the anaerobic threshold, on separate days. Blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test.

Study Timeline

• Status Verified: 2015-07
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-14
• Last Update Submitted: 2015-07-14
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15
• Study Start: 2015-10
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• healthy civilians ages 18-30.
• above average aerobic and anaerobic fitness.
• Without heart, cardiovascular, metabolic or respiratory illnesses.
• Without known medical illness or medication use that might endanger the participants.

Exclusion Criteria

• existence of any of undesired conditions detailed in the inclusion criteria.
• the physician decision.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental protocol	physical tests	50 healthy, male, trained and aged 18-30 will be recruited and asked to undergo a series of physical tests.

Primary Outcome Measures

Name	Time	Method
creatine phosphokinase (CPK)	5 experiment days for each subject	CPK is a marker for muscle damage assessed in blood test. blood sample will be taken before and after step test and running on the anaerobic threshold test.
oxygen consumption (VO2)	5 experiment days for each subject	VO2 will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test, step test and running on the anaerobic threshold test.

Secondary Outcome Measures

Name	Time	Method
lactic acid	5 experiment days for each subject	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.
Myoglobin	5 experiment days for each subject	marker from urine sample, taken before and after step test and running on the anaerobic threshold test.
Heart rate	5 experiment days for each subject	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Tel-Hashomer, Ramat- Gan, Israel