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

NCT ID: NCT01386762

Last Updated: 2011-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Spinal Cord Injury Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise intervention

6 months of intense multimodal training.

Group Type EXPERIMENTAL

Exercise training

Intervention Type OTHER

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

Interventions

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Exercise training

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* see above
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

California State University, San Marcos

OTHER

Sponsor Role lead

Responsible Party

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CSU--San Marcos

Locations

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CSU--San Marcos Human Performance Lab

San Marcos, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Todd A Astorino, Ph.D

Role: CONTACT

760 750-7351

Facility Contacts

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Todd A Astorino, Ph.D

Role: primary

760-750-7351

Other Identifiers

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85756

Identifier Type: -

Identifier Source: org_study_id

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