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Body Composition Assessment in Spinal Cord Injury

H

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status

Unknown

Conditions

Tetraplegia
Diabetes Mellitus
Spinal Cord Injury
Paraplegia
Body Composition

Treatments

Other: Body composition

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT00957762
HM12090
B6232I

Details and patient eligibility

About

The purpose of this research is to evaluate different methods of measuring body composition (amount of fat, muscle, bone, and water in your body) and to determine relationships between body composition and other medical problems associated with spinal cord injury (SCI).

Full description

A preliminary investigation in our laboratory has demonstrated the advantage of using 4-compartment modeling to assess body composition in SCI adults. In comparing body composition analyses techniques in 20 individuals with SCI, we found Total Error to be 8.0% with Dual X-ray Absorptiometry, 8.4% with hydrodensitometry, 11.5% with bioelectrical impedance analysis, and 21.8% with standard skinfold equations when compared to 4-compartment modeling, the currently accepted gold standard for body composition assessment. To date there is no gold standard for the determination of body composition in SCI individuals.

Enrollment

170 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Criteria for participation will include men and women within the age range of 18-65 years old with C5-L2 Motor-Complete (ASIA A&B)
  • SCI of duration greater than 12 months to ensure a homogenous sample.

Exclusion criteria

  • Persons with uncompensated hypothyroidism, and/or renal disease will be excluded from the study.
  • Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis
  • Pressure ulcers > Grade II will be excluded.

Trial design

170 participants in 1 patient group

Body Composition
Description:
120 subjects will help create the regression models. The remaining 50 subjects will be recruited to determine if the equations work for the population.
Treatment:
Other: Body composition

Trial contacts and locations

1

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Central trial contact

Joshua Miller, MS

Data sourced from clinicaltrials.gov

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