Spinal Cord Injury Clinical Trial
Official title:
The Use of Oxandrolone to Improve Function in Persons With Chronic Spinal Cord Injury
Verified date | May 2006 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to determine the effect of oxandrolone on the function and quality of life of patients with chronic spinal cord injury.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: Part-A - Diagnosed with a traumatic injury to spinal cord - Motor complete injury at level of C5 to T12 - Date of injury at least one year prior to enrollment - Sufficient upper body strength to participate in a 12-week resistance training program with accommodation for disability in hand strength and/or grasping - Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan - Willingness to take study medication for 12 weeks twice a day by mouth Part-B: - Diagnosed with a traumatic injury to the spinal cord - Motor incomplete injury at any level - Date of injury at least one year prior to enrollment - Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan - Ability to stand independently with or without the aid of assistive device(s) - Willingness to take study medication for 12 weeks twice a day by mouth Exclusion Criteria: Active medical problems including: - Uncontrolled diabetes - Cardiovascular disease - Cancer - Liver disease - Hypocalcaemia - Nephritic syndrome - HIV/AIDS - Pressure ulcers of grade 3 or 4 - Shoulder pathology - Pregnancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Miami Veterans Affairs Medical Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. Review. — View Citation
Cardús D, McTaggart WG. Body sodium and potassium in men with spinal cord injury. Arch Phys Med Rehabil. 1985 Mar;66(3):156-9. — View Citation
Furuno K, Goodman MN, Goldberg AL. Role of different proteolytic systems in the degradation of muscle proteins during denervation atrophy. J Biol Chem. 1990 May 25;265(15):8550-7. — View Citation
Jacobs PL, Mahoney ET, Nash MS, Green BA. Circuit resistance training in persons with complete paraplegia. J Rehabil Res Dev. 2002 Jan-Feb;39(1):21-8. — View Citation
Jacobs PL, Nash MS, Rusinowski JW. Circuit training provides cardiorespiratory and strength benefits in persons with paraplegia. Med Sci Sports Exerc. 2001 May;33(5):711-7. — View Citation
Kearns PJ, Thompson JD, Werner PC, Pipp TL, Wilmot CB. Nutritional and metabolic response to acute spinal-cord injury. JPEN J Parenter Enteral Nutr. 1992 Jan-Feb;16(1):11-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks. | |||
Primary | Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline, | |||
Primary | 12-weeks (end of intervention), and at 24-weeks. | |||
Secondary | Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community | |||
Secondary | re-integration. | |||
Secondary | Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community |
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