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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 because the information has not been verified recently.
Verified June 2011 by California State University, San Marcos.
Recruitment status was  Recruiting
National Institutes of Health (NIH)
Information provided by:
California State University, San Marcos Identifier:
First received: June 30, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
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
Other: Exercise training
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01386762

Contact: Todd A Astorino, Ph.D 760 750-7351

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   
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 Identifier: NCT01386762     History of Changes
Other Study ID Numbers: 85756 
Study First Received: June 30, 2011
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by California State University, San Marcos:

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries processed this record on May 26, 2016