Recruiting
Early Phase 1

Intense Multi-modal Training

Sponsor:

California State University, San Marcos

Code:

NCT01386762

Conditions

Spinal Cord Injury

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Exercise training

Study Details

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.

Conditions

Spinal Cord Injury

Obesity

Study ID

NCT01386762

Start date

Jun, 2011

Status verified date

Jun, 2011

Completion date

Jul, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • see above

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise intervention

6 months of intense multimodal training.

Interventions

Exercise training

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

Primary outcome measure

  • Bone mineral density [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Todd A Astorino, Ph.D

760 750-7351astorino@csusm.edu

Locations

CSU--San Marcos Human Performance Lab

Recruiting

San Marcos, California, United States, 92096

Contacts

Todd A Astorino, Ph.D

760-750-7351astorino@csusm.edu

More Information

Sponsor

California State University, San Marcos

Last update posted

Jul 1, 2011

Last verified

Jun, 2011

Keywords

  • paralysis
  • paraplegia
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by California State University, San Marcos on 2011-07-01.