NCT01696851

Brief 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 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

September 10, 2012

Last Update Submit

December 28, 2016

Conditions

Outcome Measures

Primary Outcomes (4)

  • lung function during rest using a spirometer

    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.

    5 minutes

  • Depression

    Beck questionnaire assessing depression

    5 minutes

  • Self efficacy

    Sense of self efficacy questionnaire assessing self efficacy.

    5 minutes

Study Arms (2)

wheelchair rugby players with tetraplegia

Other: tests and questionnaires

other routine sport participants with tetraplegia

Other: tests and questionnaires

Interventions

lung test, depression and self-efficacy questionnaires and Functional testing.

other routine sport participants with tetraplegiawheelchair rugby players with tetraplegia

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • subjects with tetraplegia who play wheelchair rugby

You may not qualify if:

  • suffering from a medical condition that prevents from performing the tests required by the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Physical Education Wingate

Netanya, Israel

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gabi Zeilig, Dr.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2012

First Posted

October 1, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations