Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02498366

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhabdomyolysis	Other: physical tests	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental protocol 50 healthy, male, trained and aged 18-30 will be recruited and asked to undergo a series of physical tests.	Other: physical tests each subject will undergo the following physical tests: day 1 - anthropometric measurements, wingate test and after 1 hour rest VO2max test. lactic acid levels will be measured before and after both tests. day 2 - step test day 3 - running on the anaerobic threshold. blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test in days 2 and 3.

Arm

Intervention/Treatment

Experimental: experimental protocol

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

Other: physical tests

each subject will undergo the following physical tests: day 1 - anthropometric measurements, wingate test and after 1 hour rest VO2max test. lactic acid levels will be measured before and after both tests. day 2 - step test day 3 - running on the anaerobic threshold. blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test in days 2 and 3.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba medical center	Tel-Hashomer	Ramat- Gan	Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator: Ofir Frenkel, M.D, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT02498366

Other Study ID Numbers:

2388-15-SMC

First Posted:

Jul 15, 2015

Last Update Posted:

Jul 15, 2015

Last Verified:

Jul 1, 2015

Additional relevant MeSH terms:

Rhabdomyolysis

Study Results

No Results Posted as of Jul 15, 2015