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Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00289458
First received: February 7, 2006
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
Results First Received: February 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis
Interventions: Behavioral: exercise
Behavioral: 2
Behavioral: Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Sept 2005 to 2006, posters in physician offices, senior housing, recreational facilities and advertisements in local newspaper

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Group Continued with usual activity and care, no intervention
Aquatic Exercise Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
Aquatic Exercise Plus Education 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.

Participant Flow:   Overall Study
    Control Group     Aquatic Exercise     Aquatic Exercise Plus Education  
STARTED     25     26     28  
COMPLETED     19     20     22  
NOT COMPLETED     6     6     6  
Death                 1                 0                 0  
Physician Decision                 3                 4                 2  
Withdrawal by Subject                 2                 2                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Control Group Continued with usual activity and care, no intervention
Aquatic Exercise Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
Aquatic Exercise Plus Education 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.
Total Total of all reporting groups

Baseline Measures
    Control Group     Aquatic Exercise     Aquatic Exercise Plus Education     Total  
Number of Participants  
[units: participants]
 		  25     26     28     79  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     0     0     0     0  
>=65 years     25     26     28     79  
Age  
[units: years]
Mean ± Standard Deviation 		  75.8  ± 6.2     74.4  ± 7.5     73.2  ± 4.8     74.4  ± 6.3  
Gender  
[units: participants]
 		       
Female     16     20     20     56  
Male     9     6     8     23  
Region of Enrollment  
[units: participants]
 		       
Canada     25     26     28     79  



  Outcome Measures
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1.  Primary:   Change in Balance   [ Time Frame: baseline and 11 weeks ]
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2.  Primary:   Change in Chair Stands   [ Time Frame: baseline and 11 weeks ]
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3.  Primary:   Change in Walking   [ Time Frame: baseline and 11 weeks ]
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4.  Primary:   Change in Falls-Efficacy   [ Time Frame: baseline and 11 weeks ]
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5.  Primary:   Change in Dual Task Function   [ Time Frame: baseline and 11 weeks ]
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6.  Secondary:   Change in Physical Activity   [ Time Frame: baseline and 11 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Cathy M. Arnold
Organization: University of Saskatchewan
phone: 306 966 6588
e-mail: cathy.arnold@usask.ca


No publications provided


Responsible Party: Dr. Robert Faulkner Professor, Kinesiology and Cathy Arnold (PhD candidate, Kinesiology) and Associate Professor, School of Physical Therapy, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00289458     History of Changes
Other Study ID Numbers: BIO-REB 05-158
Study First Received: February 7, 2006
Results First Received: February 13, 2009
Last Updated: July 6, 2010
Health Authority: Canada: Ethics Review Committee