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

Primary Purpose

Spinal Cord Injury, Obesity

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
California State University, San Marcos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring paralysis, paraplegia, obesity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • see above

Sites / Locations

  • CSU--San Marcos Human Performance LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise intervention

Arm Description

6 months of intense multimodal training.

Outcomes

Primary Outcome Measures

Bone mineral density
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
Total-body and regional depots of fat and fat-free mass will also be assessed in this study.

Full Information

First Posted
June 30, 2011
Last Updated
June 30, 2011
Sponsor
California State University, San Marcos
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01386762
Brief Title
Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
Official Title
Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
California State University, San Marcos
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Obesity
Keywords
paralysis, paraplegia, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise intervention
Arm Type
Experimental
Arm Description
6 months of intense multimodal training.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.
Primary Outcome Measure Information:
Title
Bone mineral density
Description
Bone mineral density of the total body, knee, hip, and spine will be assessed via dual energy x-ray absorptiometry.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body fat
Description
Total-body and regional depots of fat and fat-free mass will also be assessed in this study.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable spinal cord injury below C2 doctor's permission to participate in the study non-pregnant Exclusion Criteria: see above
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd A Astorino, Ph.D
Phone
760 750-7351
Email
astorino@csusm.edu
Facility Information:
Facility Name
CSU--San Marcos Human Performance Lab
City
San Marcos
State/Province
California
ZIP/Postal Code
92096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd A Astorino, Ph.D
Phone
760-750-7351
Email
astorino@csusm.edu

12. IPD Sharing Statement

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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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