Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02498366
Other study ID # 2388-15-SMC
Secondary ID
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


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 (PolarĀ® sensor and heart rate monitor watch). 5 experiment days for each subject Yes
See also
  Status Clinical Trial Phase
Completed NCT03737513 - Exercise-induced Collective Rhabdomyolysis
Completed NCT00241748 - Pharmacoepidemiology and Pharmacogenetics of a Statin Adverse Event N/A
Not yet recruiting NCT06429982 - Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols Phase 1
Active, not recruiting NCT06101680 - RhabdomYolyse in Intensive caRe
Withdrawn NCT02896517 - Support for the Rhabdomyolysis in an Emergency Department
Completed NCT01467180 - Myoglobin Removal by High Cut-off CVVHD N/A
Recruiting NCT01022450 - Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients N/A
Completed NCT00391911 - Study of N-Acetylcysteine (NAC) and Continuous Renal Replacement Therapy (CRRT) for the Treatment of Rhabdomyolysis Phase 2
Withdrawn NCT02111018 - Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis Phase 2
Completed NCT04913298 - Prospective Study for the Application of Cytosorb® in Critically Ill Patients N/A
Recruiting NCT05146336 - CytOSorb TreatMent Of Critically Ill PatientS Registry
Completed NCT03986736 - Markers of Tissue Injury and Rhabdomyolysis in Patients With Major Trauma
Not yet recruiting NCT02518724 - The Effect of Remote Ischemic Preconditioning on Physical Performance and Exertional Rhabdomyolysis N/A
Completed NCT02671604 - Rhabdomyolysis and Robot-assisted Radical Prostatectomy N/A
Completed NCT00592657 - Incidence of Rhabdomyolysis Among Patients Admitted With Jimsonweed Ingestions N/A
Completed NCT06338423 - Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure N/A
Completed NCT01976936 - Neuroprotection With Statin Therapy for Acute Recovery Trial Phase 2 Phase 2
Completed NCT04118608 - Rhabdomyolysis - a Study of Patient Characteristics and Laboratory Values to Guide Treatment
Completed NCT01544231 - Plasma Neutrophil Gelatinase Associated Lipocalin Levels During Emergency Management of Rhabdomyolysis N/A
Recruiting NCT00549029 - The Association of Genetic Polymorphisms With Statin-Induced Myopathy. N/A