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Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01386762
Recruitment Status : Unknown
Verified June 2011 by California State University, San Marcos.
Recruitment status was:  Recruiting
First Posted : July 1, 2011
Last Update Posted : July 1, 2011
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
California State University, San Marcos

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE July 1, 2011
Last Update Posted Date July 1, 2011
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
Bone mineral density [ Time Frame: 6 months ]
Bone mineral density of the total body, knee, hip, and spine will be assessed via dual energy x-ray absorptiometry.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2011)
Body fat [ Time Frame: 6 months ]
Total-body and regional depots of fat and fat-free mass will also be assessed in this study.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
Official Title  ICMJE Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
Brief Summary Bone loss is a common secondary complication of spinal cord injury (SCI), and treatments used to reverse this condition have equivocal effectiveness. The aim of this study is to determine the effect of intense multi-modal training on bone health, body fat, and quality of life in persons with SCI. Participants will complete 6 months of training during which various measures will be obtained at 0, 3, and 6 months. Control subjects are also being recruited to complete testing but not participate in training.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injury
  • Obesity
Intervention  ICMJE Other: Exercise training
6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.
Study Arms Experimental: Exercise intervention
6 months of intense multimodal training.
Intervention: Other: Exercise training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 30, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stable spinal cord injury below C2
  • doctor's permission to participate in the study
  • non-pregnant

Exclusion Criteria:

  • see above
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01386762
Other Study ID Numbers  ICMJE 85756
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Todd A. Astorino Ph.D, CSU--San Marcos
Study Sponsor  ICMJE California State University, San Marcos
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account California State University, San Marcos
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP