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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00289458
Other study ID # BIO-REB 05-158
Secondary ID
Status Completed
Phase Phase 1
First received February 7, 2006
Last updated July 6, 2010
Start date October 2005
Est. completion date April 2008

Study information

Verified date July 2010
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
exercise
A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
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.
Control
no exercise

Locations

Country Name City State
Canada College of Kinesiology Saskatoon Saskatchewan

Sponsors (2)

Lead Sponsor Collaborator
University of Saskatchewan Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Balance Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance) baseline and 11 weeks No
Primary Change in Chair Stands change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds) baseline and 11 weeks No
Primary Change in Walking change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks baseline and 11 weeks No
Primary Change in Falls-Efficacy change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence) baseline and 11 weeks No
Primary Change in Dual Task Function change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance) baseline and 11 weeks No
Secondary Change in Physical Activity change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active) baseline and 11 weeks No
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