NCT01386762

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2011

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

4.1 years

First QC Date

June 30, 2011

Last Update Submit

June 30, 2011

Conditions

Spinal Cord InjuryObesity

Keywords

paralysisparaplegiaobesity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Body fat

    6 months

Study Arms (1)

Exercise intervention

EXPERIMENTAL

6 months of intense multimodal training.

Other: Exercise training

Interventions

Exercise trainingOTHER

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

Exercise intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • see above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSU--San Marcos Human Performance Lab

San Marcos, California, 92096, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesObesityParalysisParaplegia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Todd A Astorino, Ph.D

CONTACT

760 750-7351astorino@csusm.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2011

First Posted

July 1, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

US(1)