Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 9:20 PM
Study NCT ID:
NCT01696851
Status:
WITHDRAWN
Last Update Posted:
2016-12-29
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological and Psycho-social Variables of People With a Spinal Cord Injury Participating in Competitive Rugby in Wheelchairs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no more interested in this issue', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-28', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung function during rest using a spirometer', 'timeFrame': 'one minute'}, {'measure': 'Functional testing', 'timeFrame': '5 minutes', 'description': '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.'}, {'measure': 'Depression', 'timeFrame': '5 minutes', 'description': 'Beck questionnaire assessing depression'}, {'measure': 'Self efficacy', 'timeFrame': '5 minutes', 'description': 'Sense of self efficacy questionnaire assessing self efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wheelchair Rugby Players With Tetraplegia']}, 'descriptionModule': {'briefSummary': 'People with Spinal cord injury with tetraplegia suffer from respiratory problem due to weakness of the muscles and because the autonomic system dysfunction.\n\nExercise 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.\n\nWheelchair 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.\n\nIn 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Wheelchair rugby players with SCI with four limbs paralyzed playing and practicing regularly. Season lasts about six months.\n\nBelonging 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects with tetraplegia who play wheelchair rugby\n\nExclusion Criteria:\n\n* suffering from a medical condition that prevents from performing the tests required by the study protocol.'}, 'identificationModule': {'nctId': 'NCT01696851', 'briefTitle': 'Physiological and Psycho-social Variables of People With a Spinal Cord Injury Participating in Competitive Rugby in Wheelchairs', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Physiological and Psycho-social Variables of People With a Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'SHEBA-10-8276-GZ-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'wheelchair rugby players with tetraplegia', 'interventionNames': ['Other: tests and questionnaires']}, {'label': 'other routine sport participants with tetraplegia', 'interventionNames': ['Other: tests and questionnaires']}], 'interventions': [{'name': 'tests and questionnaires', 'type': 'OTHER', 'description': 'lung test, depression and self-efficacy questionnaires and Functional testing.', 'armGroupLabels': ['other routine sport participants with tetraplegia', 'wheelchair rugby players with tetraplegia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'facility': 'College of Physical Education Wingate', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'overallOfficials': [{'name': 'Gabi Zeilig, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}