Back to resultsExertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
Primary Purpose
Rhabdomyolysis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
physical tests
Sponsored by
About this trial
This is an interventional basic science trial for Rhabdomyolysis
Eligibility Criteria
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.
Sites / Locations
- Sheba medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental protocol
Arm Description
50 healthy, male, trained and aged 18-30 will be recruited and asked to undergo a series of physical tests.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Myoglobin
marker from urine sample, taken before and after step test and running on the anaerobic threshold test.
Heart rate
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02498366
Brief Title
Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
Official Title
Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhabdomyolysis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental protocol
Arm Type
Experimental
Arm Description
50 healthy, male, trained and aged 18-30 will be recruited and asked to undergo a series of physical tests.
Intervention Type
Other
Intervention Name(s)
physical tests
Intervention Description
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.
Primary Outcome Measure Information:
Title
creatine phosphokinase (CPK)
Description
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.
Time Frame
5 experiment days for each subject
Title
oxygen consumption (VO2)
Description
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.
Time Frame
5 experiment days for each subject
Secondary Outcome Measure Information:
Title
lactic acid
Description
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.
Time Frame
5 experiment days for each subject
Title
Myoglobin
Description
marker from urine sample, taken before and after step test and running on the anaerobic threshold test.
Time Frame
5 experiment days for each subject
Title
Heart rate
Description
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Time Frame
5 experiment days for each subject
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ofir Frenkel, M.D
Phone
+972529243399
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofir Frenkel, M.D
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel-Hashomer
State/Province
Ramat- Gan
Country
Israel
12. IPD Sharing Statement
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Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
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