Spinal Cord InjuryEarly Phase 1NCT01386762
Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
A Early Phase 1 study testing Exercise training in people with Spinal Cord Injury and Obesity, run by California State University, San Marcos at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Spinal Cord Injury, Obesity
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stable spinal cord injury below C2
- doctor's permission to participate in the study
- non-pregnant
Who cannot join
- see above
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CSU--San Marcos Human Performance Lab
San Marcos, California, 92096
Todd A Astorino, Ph.D, 760-750-7351, astorino@csusm.edu
About this study
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
- Being tested
- Exercise training
- Keywords
- paralysis, paraplegia, obesity
- Medical subject headings
- Spinal Cord Injuries, Obesity, Paralysis, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | 6 months of intense multimodal training. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone mineral density of the total body, knee, hip, and spine will be assessed via dual energy x-ray absorptiometry.
Measured: 6 months
Secondary outcomes (1)
Body fat
Total-body and regional depots of fat and fat-free mass will also be assessed in this study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, San Marcos
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386762
- Sponsor's protocol ID
- 85756
- Status last verified
- Jun 2011
- First submitted
- 30 Jun 2011
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01386762
- Acronym / sponsor ID
- 85756
- Conditions
- Spinal Cord Injury, Obesity
- Keywords
- paralysis, paraplegia, obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- California State University, San MarcosUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Other: Exercise training6 months of intense multimodal training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Stable spinal cord injury below C2
- doctor's permission to participate in the study
- non-pregnant
Key exclusion criteria (1 listed)
- see above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc. | Other | Exercise intervention |
Primary outcome
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.
1 secondary outcome
Body fat
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exercise training in people with Spinal Cord Injury and Obesity, run by California State University, San Marcos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Todd A Astorino, Ph.D (760 750-7351, astorino@csusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.