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

Primary Purpose

Arthritis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
exercise
2
Control
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis focused on measuring older adults, falls, arthritis, aquatic, exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • College of Kinesiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Aquatic Education

Aquatic

Control

Arm Description

Exercise combined with education

Outcomes

Primary Outcome Measures

Change in Balance
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
Change in Chair Stands
change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
Change in Walking
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
Change in Falls-Efficacy
change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
Change in Dual Task Function
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)

Secondary Outcome Measures

Change in Physical Activity
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)

Full Information

First Posted
February 7, 2006
Last Updated
July 6, 2010
Sponsor
University of Saskatchewan
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00289458
Brief Title
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
Keywords
older adults, falls, arthritis, aquatic, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic Education
Arm Type
Experimental
Arm Description
Exercise combined with education
Arm Title
Aquatic
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
Intervention Type
Behavioral
Intervention Name(s)
2
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
no exercise
Primary Outcome Measure Information:
Title
Change in Balance
Description
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
Time Frame
baseline and 11 weeks
Title
Change in Chair Stands
Description
change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
Time Frame
baseline and 11 weeks
Title
Change in Walking
Description
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
Time Frame
baseline and 11 weeks
Title
Change in Falls-Efficacy
Description
change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
Time Frame
baseline and 11 weeks
Title
Change in Dual Task Function
Description
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
Time Frame
baseline and 11 weeks
Secondary Outcome Measure Information:
Title
Change in Physical Activity
Description
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
Time Frame
baseline and 11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy M Arnold, MSc
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Kinesiology
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5B2
Country
Canada

12. IPD Sharing Statement

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

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