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Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

Exertional Rhabdomyolysis- Characterization of Prediction Tests for Return to Duty

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02498366
Enrollment
50
Registered
2015-07-15
Start date
2015-10-31
Completion date
2016-12-31
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhabdomyolysis

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.

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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
creatine phosphokinase (CPK)5 experiment days for each subjectCPK 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 subjectVO2 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

MeasureTime frameDescription
lactic acid5 experiment days for each subjectlactic 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.
Myoglobin5 experiment days for each subjectmarker from urine sample, taken before and after step test and running on the anaerobic threshold test.
Heart rate5 experiment days for each subjectThe heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).

Countries

Israel

Contacts

Primary ContactOfir Frenkel, M.D
+972529243399

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026