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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01386762
• Other study ID #: 85756
• Status: Recruiting
• Phase: Phase 0
• First received: June 30, 2011
• Last updated: June 30, 2011
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: June 2011
• Source: California State University, San Marcos
• Contact: Todd A Astorino, Ph.D
• Phone: 760 750-7351
• Email: astorino[@]csusm.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Stable spinal cord injury below C2

• doctor's permission to participate in the study

• non-pregnant

Exclusion Criteria:

• see above

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Other:
• Exercise training
6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.

Locations

Country	Name	City	State
United States	CSU--San Marcos Human Performance Lab	San Marcos	California

Sponsors (2)

Lead Sponsor	Collaborator
California State University, San Marcos	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	Bone mineral density of the total body, knee, hip, and spine will be assessed via dual energy x-ray absorptiometry.	6 months	No
Secondary	Body fat	Total-body and regional depots of fat and fat-free mass will also be assessed in this study.	6 months	No