Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01696851
Other study ID # SHEBA-10-8276-GZ-CTIL
Secondary ID
Status Withdrawn
Phase N/A
First received September 10, 2012
Last updated December 28, 2016
Start date September 2012

Study information

Verified date December 2016
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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 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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- subjects with tetraplegia who play wheelchair rugby

Exclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel College of Physical Education Wingate Netanya

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary lung function during rest using a spirometer one minute No
Primary 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 No
Primary Depression Beck questionnaire assessing depression 5 minutes No
Primary Self efficacy Sense of self efficacy questionnaire assessing self efficacy. 5 minutes No