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Trial record 1 of 1 for:    Todd's Paralysis
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Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by California State University, San Marcos.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01386762
First Posted: July 1, 2011
Last Update Posted: July 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
California State University, San Marcos
  Purpose
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.

Condition Intervention Phase
Spinal Cord Injury Obesity Other: Exercise training Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by California State University, San Marcos:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Body fat [ Time Frame: 6 months ]
    Total-body and regional depots of fat and fat-free mass will also be assessed in this study.


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise intervention
6 months of intense multimodal training.
Other: Exercise training
6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • see above
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386762


Contacts
Contact: Todd A Astorino, Ph.D 760 750-7351 astorino@csusm.edu

Locations
United States, California
CSU--San Marcos Human Performance Lab Recruiting
San Marcos, California, United States, 92096
Contact: Todd A Astorino, Ph.D    760-750-7351    astorino@csusm.edu   
Sponsors and Collaborators
California State University, San Marcos
National Institutes of Health (NIH)
  More Information

Responsible Party: Todd A. Astorino Ph.D, CSU--San Marcos
ClinicalTrials.gov Identifier: NCT01386762     History of Changes
Other Study ID Numbers: 85756
First Submitted: June 30, 2011
First Posted: July 1, 2011
Last Update Posted: July 1, 2011
Last Verified: June 2011

Keywords provided by California State University, San Marcos:
paralysis
paraplegia
obesity

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System