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| Tracking Information | |||||
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| First Received Date ICMJE | October 4, 2007 | ||||
| Last Updated Date | August 31, 2009 | ||||
| Start Date ICMJE | October 2004 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00540683 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Measurement of the Distribution of Optical Properties in Adult Human Muscle | ||||
| Official Title ICMJE | Measurement of the Distribution of Optical Properties in Adult Human Muscle | ||||
| Brief Summary | At Beckman Laser Institute, University of California,Irvine. We have developed a diagnostic device use Near-Infrared Tissue Optics as a means to monitor muscle physiology, for example during exercise or in response to external factors such as shock. The red to near-infrared (NIR) part of the electromagnetic spectrum (600 to 1000 nm) allows photons to penetrate a few centimeters below the surface of the skin. These photons are non-ionizing and do not induce local heating. Quantitative optical spectroscopy in the NIR allows for safe, non-invasive measurements of the concentrations of blood, water, and lipids in tissues. Diffuse Optical Spectroscopy (DOS) has been in use for clinical studies(UCI HS#1995-563, HS#2002-2306), These studies have clearly shown the enormous sensitivity of DOS to hemodynamic events in tissues. These hemodynamic parameters have been shown to correlate with invasive measures of cardiac output, mean arterial pressure, blood loss, and blood hemoglobin concentration. Thus the DOS signal is more representative of the perfusion of blood and consumption of oxygen in the muscle. Hypotheses; The optical properties of muscle vary with age, gender, and muscle fitness level. NIR optical scattering and total hemoglobin concentration are both expected to decrease with age and increase with muscle fitness level. The application of a two-layer model to the muscle/fat layer system will improve the reliability of DOS measurements over the standard homogenous model. Changes in optical properties are indicative of response to exercise training
Muscle tissues that display cachexia will display optical properties that are significantly lower than those of muscle tissues in normal subjects. Cellulite will have a different effect on light transmission than "normal" adipose tissues. Changes in tissue oxygenation and metabolism can be quantified using DOS during alterations in deep tissue temperature. |
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| Detailed Description | Procedure; Measurement sites for this study will include major muscle groups in the arms, legs and abdomen/back. The optical measurement consists of placing a pen shape probe onto the surface of the body. The optical probe consists of optical fibers and a plastic holder. Total measurement time will be less than 20 minutes. Anticipate Risk and Benefit; Near-infrared light does not ionize biological tissue and poses no significant health risk. The measurement is painless, and no discomfort. There are however, risks that are currently unforeseeable. There are no direct benefits to participants in this protocol. Results from this research will be used to develop devices that would be beneficial to others in sports medicine and critical care medicine. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Diffuse Optical Spectroscopy | ||||
| Study Arms / Comparison Groups | Muscle properties | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00540683 | ||||
| Responsible Party | Albert Cerussi,PhD., Beckman Laser Institute | ||||
| Study ID Numbers ICMJE | LAMMP DOS-RR-01192-29 | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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