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

June 30, 2011 updated by: California State University, San Marcos
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Marcos, California, United States, 92096
        • Recruiting
        • CSU--San Marcos Human Performance Lab
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • see above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat
Time Frame: 6 months
Total-body and regional depots of fat and fat-free mass will also be assessed in this study.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California State University, San Marcos

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

June 30, 2011

First Submitted That Met QC Criteria

June 30, 2011

First Posted (Estimate)

July 1, 2011

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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