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

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ClinicalTrials.gov Identifier: NCT00289458
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : August 3, 2010
Last Update Posted : August 3, 2010
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 9, 2006
Results First Submitted Date February 13, 2009
Results First Posted Date August 3, 2010
Last Update Posted Date August 3, 2010
Study Start Date  ICMJE October 2005
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
  • Change in Balance [ Time Frame: baseline and 11 weeks ]
    Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
  • Change in Chair Stands [ Time Frame: baseline and 11 weeks ]
    change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
  • Change in Walking [ Time Frame: baseline and 11 weeks ]
    change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
  • Change in Falls-Efficacy [ Time Frame: baseline and 11 weeks ]
    change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
  • Change in Dual Task Function [ Time Frame: baseline and 11 weeks ]
    change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
  • balance
  • strength
  • mobility
  • function
  • efficacy
  • physical activity
  • intent to exercise
Change History Complete list of historical versions of study NCT00289458 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
Change in Physical Activity [ Time Frame: baseline and 11 weeks ]
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Exercise 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.

This 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.

Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis
Intervention  ICMJE
  • Behavioral: exercise
    A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
  • Behavioral: 2
    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.
  • Behavioral: Control
    no exercise
Study Arms
  • Experimental: Aquatic Education
    Exercise combined with education
    Intervention: Behavioral: 2
  • Experimental: Aquatic
    Intervention: Behavioral: exercise
  • Placebo Comparator: Control
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2010)
79
Original Enrollment  ICMJE
 (submitted: February 7, 2006)
90
Actual Study Completion Date April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • over age 65
  • clinical diagnosis of hip osteoarthritis

Exclusion Criteria:

  • medical condition tha significantly decreases functional ability such that not safe to exercise in a community program
  • already exercising in a moderate exercise program 2/week or more
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00289458
Other Study ID Numbers  ICMJE BIO-REB 05-158
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Robert Faulkner Professor, Kinesiology and Cathy Arnold (PhD candidate, Kinesiology) and Associate Professor, School of Physical Therapy, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Cathy M Arnold, MSc University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP