Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

Rhabdomyolysis Clinical Trial

Official title:

Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02498366
• Other study ID #: 2388-15-SMC
• Status: Not yet recruiting
• Phase: N/A
• First received: July 13, 2015
• Last updated: July 14, 2015
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Sheba Medical Center
• Contact: Ofir Frenkel, M.D
• Phone: +972529243399
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• 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:

• 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Rhabdomyolysis

Intervention

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.

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 and running on the anaerobic threshold test.	5 experiment days for each subject	No
Primary	oxygen consumption (VO2)	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.	5 experiment days for each subject	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.	5 experiment days for each subject	No
Secondary	Myoglobin	marker from urine sample, taken before and after step test and running on the anaerobic threshold test.	5 experiment days for each subject	No
Secondary	Heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	5 experiment days for each subject	Yes