Wheelchair Rugby Players With TetraplegiaNCT01696851
Physiological and Psycho-social Variables of People With a Spinal Cord Injury Participating in Competitive Rugby in Wheelchairs
An observational study of Wheelchair Rugby Players With Tetraplegia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
People with Spinal cord injury with tetraplegia suffer from respiratory problem due to weakness of the muscles and because the autonomic system dysfunction. Exercise is one way of preserving and improving physical fitness and directly and indirectly reduce risk factors such as insulin resistance, weight loss and low… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wheelchair Rugby Players With Tetraplegia
- What is being tested?
- tests and questionnaires
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Wheelchair rugby players with SCI with four limbs paralyzed playing and practicing regularly. Season lasts about six months. Belonging to this group are training and playing regularly twice a week about 3 hours at a time, total of 6 hours per week under the supervision of two coaches who attend every practice and game.
Who may be able to join
- subjects with tetraplegia who play wheelchair rugby
Who cannot join
- suffering from a medical condition that prevents from performing the tests required by the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological and Psycho-social Variables of People With a Spinal Cord Injury
People with Spinal cord injury with tetraplegia suffer from respiratory problem due to weakness of the muscles and because the autonomic system dysfunction.
Exercise is one way of preserving and improving physical fitness and directly and indirectly reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects with spinal cord injury with tetraplegia have limited options for exercise: table tennis, gym, pool and more. Because of the nature of the injury which includes the sympathetic failure, they can not easily get the desired pulse to improve physical fitness.
Read more
Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could not participate in wheelchair basketball. The game combines short, quick races with different aerobic capabilities. Previous studies have shown that participants in wheelchair rugby Improve anaerobic power, oxygen consumption, physical fitness and daily functioning. Wheelchair rugby improves self-confidence and as a result it affects other areas of life. Another study examined sense of self-efficacy, saw improvement in this index for rugby players in a wheelchair at high levels.
In the present study the investigators aim to examine whether regular participation in wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym, swimming).
- Being tested
- tests and questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tests and questionnairesOther
lung test, depression and self-efficacy questionnaires and Functional testing.
| Study group | Role | What they receive |
|---|---|---|
| wheelchair rugby players with tetraplegia | Not described Receives: Other: tests and questionnaires | |
| other routine sport participants with tetraplegia | Not described Receives: Other: tests and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung function during rest using a spirometer
Measured: one minute
Functional testing
getting on a 6 meters long ramp adapted to the ability of people with tetraplegia (this takes up to 30 seconds). And opening and closing a sliding door.
Measured: 5 minutes
Depression
Beck questionnaire assessing depression
Measured: 5 minutes
Self efficacy
Sense of self efficacy questionnaire assessing self efficacy.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
Why it stopped: no more interested in this issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wheelchair Rugby Players With TetraplegiaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gabi Zeilig, Dr., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696851
- Sponsor's protocol ID
- SHEBA-10-8276-GZ-CTIL
- Status last verified
- Dec 2016
- First submitted
- 10 Sep 2012
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Psycho-social Variables of People With a Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01696851
- Acronym / sponsor ID
- SHEBA-10-8276-GZ-CTIL
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no more interested in this issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- First posted
- 1 Oct 2012 (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.
People with Spinal cord injury with tetraplegia suffer from respiratory problem due to weakness of the muscles and because the autonomic system dysfunction.
Exercise is one way of preserving and improving physical fitness and directly and indirectly reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects with spinal cord injury with tetraplegia have limited options for exercise: table tennis, gym, pool and more. Because of the nature of the injury which includes the sympathetic failure, they can not easily get the desired pulse to improve physical fitness.
Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could not participate in wheelchair basketball. The game combines short, quick races with different aerobic capabilities. Previous studies have shown that participants in wheelchair rugby Improve anaerobic power, oxygen consumption, physical fitness and daily functioning. Wheelchair rugby improves self-confidence and as a result it affects other areas of life. Another study examined sense of self-efficacy, saw improvement in this index for rugby players in a wheelchair at high levels.
In the present study the investigators aim to examine whether regular participation in wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym, swimming).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wheelchair rugby players with tetraplegia | – | Other: tests and questionnaires |
| other routine sport participants with tetraplegia | – | Other: tests and questionnaires |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Wheelchair rugby players with SCI with four limbs paralyzed playing and practicing regularly. Season lasts about six months. Belonging to this group are training and playing regularly twice a week about 3 hours at a time, total of 6 hours per week under the supervision of two coaches who attend every practice and game.
Key inclusion criteria (1 listed)
- subjects with tetraplegia who play wheelchair rugby
Key exclusion criteria (1 listed)
- suffering from a medical condition that prevents from performing the tests required by the study protocol.
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 |
|---|---|---|
| tests and questionnaireslung test, depression and self-efficacy questionnaires and Functional testing. | Other | other routine sport participants with tetraplegia, wheelchair rugby players with tetraplegia |
Primary outcome
lung function during rest using a spirometer
Time frame: one minute
Functional testing
Time frame: 5 minutes
getting on a 6 meters long ramp adapted to the ability of people with tetraplegia (this takes up to 30 seconds). And opening and closing a sliding door.
Depression
Time frame: 5 minutes
Beck questionnaire assessing depression
Self efficacy
Time frame: 5 minutes
Sense of self efficacy questionnaire assessing self efficacy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
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.
Gabi Zeilig, Dr. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheelchair Rugby Players With Tetraplegia, run by Sheba Medical Center at 1 site in Israel.
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: withdrawn, as of the sponsor's last update on 29 Dec 2016. 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 Israel. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
lung function during rest using a spirometer (time frame: one minute). The study lists 4 primary outcomes in all. 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 Dec 2016.