Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 15, 2015
July 1, 2015
1 year
July 13, 2015
July 14, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (3)
lactic acid
5 experiment days for each subject
Myoglobin
5 experiment days for each subject
Heart rate
5 experiment days for each subject
Study Arms (1)
experimental protocol
EXPERIMENTAL50 healthy, male, trained and aged 18-30 will be recruited and asked to undergo a series of physical tests.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- the physician decision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba medical center
Tel Litwinsky, Ramat- Gan, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ofir Frenkel, M.D
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2015
First Posted
July 15, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
July 15, 2015
Record last verified: 2015-07