Spinal Cord InjuryNCT02850133
Aerobic Exercise and Blood Biochemical Factors in Spinal Cord Injury
A study testing aerobic exercise training in people with Spinal Cord Injury, run by National Taiwan University Hospital.
Trial summary
Background: Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jul 2013
- Phase
- Interventional
- 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >20 years, male sex, and onset of injury more than one year
Who cannot join
- known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers
About this study
Official title: Effect of Aerobic Exercise Training on the Blood Biochemical Factors and Peripheral Hemodynamics in Person With Spinal Cord Injury
Background:
Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with SCI.
Read more
Method:
Male patients with SCI and age- and sex-matched healthy individuals were recruited. Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with SCI post-training.
Read the detailed description
The patients with SCI were invited to undergo a 12- to 16-week exercise training by arm ergometry. The exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.
- Conditions
- Spinal Cord Injury
- Being tested
- aerobic exercise training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise trainingOther
aerobic exercise training for 36 sessions within 12-16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injury | Experimental | Cardio-pulmonary exercise testing and aerobic exercise training Receives: Other: aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum myokines
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startAug 2010
- Primary completionJul 2013
- Study completionJul 2013
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850133
- Sponsor's protocol ID
- 201007031R
- Status last verified
- Jul 2016
- First submitted
- 1 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The study is registered in publicly accessible site.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Training on the Blood Biochemical Factors and Peripheral Hemodynamics in Person With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02850133
- Acronym / sponsor ID
- 201007031R
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Jul 2016 (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.
Background:
Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with SCI.
Method:
Male patients with SCI and age- and sex-matched healthy individuals were recruited. Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with SCI post-training.
Detailed description
The patients with SCI were invited to undergo a 12- to 16-week exercise training by arm ergometry. The exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injury | Experimental | Other: aerobic exercise trainingCardio-pulmonary exercise testing and aerobic exercise training |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age >20 years, male sex, and onset of injury more than one year
Key exclusion criteria (1 listed)
- known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers
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 |
|---|---|---|
| aerobic exercise trainingaerobic exercise training for 36 sessions within 12-16 weeks | Other | Spinal cord injury |
Primary outcome
serum myokines
Time frame: 12-16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: Yes. The study is registered in publicly accessible site.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise training in people with Spinal Cord Injury, run by National Taiwan University Hospital.
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 1 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: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum myokines (time frame: 12-16 weeks). 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 29 Jul 2016; AzTrials last refreshed its copy on 8 Nov 2026.