Effect of Intense Multi-modal Training on Bone Health and... | NCT01386762

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

NCT01386762

Sponsor

California State University, San Marcos

Status

Unknown status

Last Update Posted

Jul 1, 2011Estimated

Enrollment

30Estimated

Phase

Early Phase 1

Conditions

Spinal Cord Injury
Obesity

Interventions

Exercise training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Jun 30, 2011

First Submission Date that Met QC Criteria

Jun 30, 2011

First Posted Date

Jul 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2011

Last Update Posted Date

Jul 1, 2011Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise intervention	Experimental	6 months of intense multimodal training.	Other: Exercise training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training	Other	6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.	Exercise intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

see above

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Todd A Astorino, Ph.D	Contact	760 750-7351		astorino@csusm.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CSU--San Marcos Human Performance Lab	Recruiting	San Marcos	California	92096	United States

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D009765	Obesity
D010243	Paralysis
D010264	Paraplegia

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided