Viewing Study NCT00289458


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Study NCT ID: NCT00289458
Status: COMPLETED
Last Update Posted: 2010-08-03
First Post: 2006-02-07
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
Sponsor:
Organization:

Raw JSON

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Arnold', 'organization': 'University of Saskatchewan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention', 'otherNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility', 'otherNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.', 'otherNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Balance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'OG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'OG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 11 weeks', 'description': 'Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT and LOCF'}, {'type': 'PRIMARY', 'title': 'Change in Chair Stands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'OG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'OG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)', 'unitOfMeasure': 'number of stands per 30 seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT and LOCF'}, {'type': 'PRIMARY', 'title': 'Change in Walking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'OG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'OG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '70.7', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '70.3', 'groupId': 'OG001'}, {'value': '43.3', 'spread': '63.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks', 'unitOfMeasure': 'unit of scale (meters per 6 minutes)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT and LOCF'}, {'type': 'PRIMARY', 'title': 'Change in Falls-Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'OG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'OG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '12.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)', 'unitOfMeasure': 'unit of scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT and LOCF'}, {'type': 'SECONDARY', 'title': 'Change in Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'OG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'OG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.4', 'spread': '47.3', 'groupId': 'OG000'}, {'value': '106.9', 'spread': '50.4', 'groupId': 'OG001'}, {'value': '96.6', 'spread': '32.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)', 'unitOfMeasure': 'unit of scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Dual Task Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'OG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'OG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)', 'unitOfMeasure': 'unit of scale (seconds)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'FG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'FG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Recruitment Sept 2005 to 2006, posters in physician offices, senior housing, recreational facilities and advertisements in local newspaper'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Continued with usual activity and care, no intervention'}, {'id': 'BG001', 'title': 'Aquatic Exercise', 'description': 'Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility'}, {'id': 'BG002', 'title': 'Aquatic Exercise Plus Education', 'description': 'Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '74.4', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '73.2', 'spread': '4.8', 'groupId': 'BG002'}, {'value': '74.4', 'spread': '6.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-06', 'studyFirstSubmitDate': '2006-02-07', 'resultsFirstSubmitDate': '2009-02-13', 'studyFirstSubmitQcDate': '2006-02-07', 'lastUpdatePostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-06', 'studyFirstPostDateStruct': {'date': '2006-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Balance', 'timeFrame': 'baseline and 11 weeks', 'description': 'Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)'}, {'measure': 'Change in Chair Stands', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)'}, {'measure': 'Change in Walking', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks'}, {'measure': 'Change in Falls-Efficacy', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)'}, {'measure': 'Change in Dual Task Function', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)'}], 'secondaryOutcomes': [{'measure': 'Change in Physical Activity', 'timeFrame': 'baseline and 11 weeks', 'description': 'change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)'}]}, 'conditionsModule': {'keywords': ['older adults, falls, arthritis, aquatic, exercise'], 'conditions': ['Arthritis']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to determine the effect of aquatic exercise and aquatic exercise combined with an education program on decreasing fall risk in older adults with hip osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and balance and the addition of the education session will enhance confidence in movement.', 'detailedDescription': 'Older adults with hip osteoarthritis (OA) often experience pain and loss of mobility that significantly impairs their ability to walk, climb stairs, shop or participate in exercise programs. This can result in social isolation, depression and loss of confidence in their ability to manage independently in the community. A decline in physical and psycho-social function leads to increased risk of falling. It is crucial to identify high-risk fallers as well as the best interventions to decrease that risk; hip fractures from falls are devastating, resulting in death or admission to long-term care for the majority who sustain them.\n\nExercise programs designed to improve balance, strength and mobility can help to improve function and decrease risk of falling. However, individuals with hip OA may have difficulty participating in these programs due to pain. Aquatic exercise offers an activity alternative to improve mobility, strength and decrease fall risk. As well, the addition of a group program designed to enhance confidence in movement may further reduce the risk of falls by improving independence to be more active at home and in the community.\n\nThis project will evaluate the effect of aquatic exercise and aquatic exercise combined with a group educational program on decreasing fall risk in older adults with hip OA. Determining optimal fall prevention programs may avert death and loss of quality of life for older adults, clearly an important contribution to preventative health care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over age 65\n* clinical diagnosis of hip osteoarthritis\n\nExclusion Criteria:\n\n* medical condition tha significantly decreases functional ability such that not safe to exercise in a community program\n* already exercising in a moderate exercise program 2/week or more'}, 'identificationModule': {'nctId': 'NCT00289458', 'briefTitle': 'Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'The Effect of Aquatic Exercise and Aquatic Exercise Combined With Education and Efficacy Enhancement on Improving Indices of Fall Risk in Older Adults With Hip Osteoarthritis: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'BIO-REB 05-158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aquatic Education', 'description': 'Exercise combined with education', 'interventionNames': ['Behavioral: 2']}, {'type': 'EXPERIMENTAL', 'label': 'Aquatic', 'interventionNames': ['Behavioral: exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.', 'armGroupLabels': ['Aquatic']}, {'name': '2', 'type': 'BEHAVIORAL', 'description': 'Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.', 'armGroupLabels': ['Aquatic Education']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'no exercise', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 5B2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'College of Kinesiology', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Cathy M Arnold, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr. Robert Faulkner Professor, Kinesiology and Cathy Arnold (PhD candidate, Kinesiology) and Associate Professor, School of Physical Therapy', 'oldOrganization': 'University of Saskatchewan'}}}}