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

This study is currently recruiting participants.
Verified June 2011 by California State University, San Marcos
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
California State University, San Marcos
ClinicalTrials.gov Identifier:
NCT01386762
First received: June 30, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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
 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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Todd A. Astorino Ph.D, CSU--San Marcos
ClinicalTrials.gov 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:
paralysis
paraplegia
obesity

Additional relevant MeSH terms:
Obesity
Spinal Cord Injuries
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013