- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00289458
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 5B2
- College of Kinesiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
|
no exercise
|
Experimental: Aquatic Education
Exercise combined with education
|
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.
|
Experimental: Aquatic
|
A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline and 11 weeks
|
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)
|
baseline and 11 weeks
|
Change in Walking
Time Frame: baseline and 11 weeks
|
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
|
baseline and 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)
|
baseline and 11 weeks
|
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)
|
baseline and 11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline and 11 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cathy M Arnold, MSc, University of Saskatchewan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-REB 05-158
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis
-
Northumbria Healthcare NHS Foundation TrustUniversity of YorkRecruitingKnee Arthritis | Hip ArthritisUnited Kingdom
-
MedShape, IncOrthopedic Foot and Ankle Center, Ohio; CurveBeam LLCRecruitingAnkle Arthritis | Arthritis FootUnited States
-
Chang Gung Memorial HospitalNot yet recruitingArthritis Knee | Arthritis HipTaiwan
-
MedShape, IncSaint Alphonsus Medical GroupUnknownAnkle Arthritis | Foot ArthritisUnited States
-
MedShape, IncUniversity of Alabama at BirminghamRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
University of Alabama at BirminghamMedShape, IncRecruiting
-
MedShape, IncThe University of Texas Medical Branch, GalvestonRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
Saint Alphonsus Regional Medical CenterCompletedArthritis Knee | Arthritis of HipUnited States
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoCompleted
-
Smith & Nephew, Inc.TerminatedRheumatoid Arthritis | Traumatic Arthritis | Osteo Arthritis ShouldersUnited States
Clinical Trials on 2
-
University College, LondonMoorfields Eye Hospital NHS Foundation Trust; Targeted Genetics CorporationCompletedRetinal DegenerationUnited Kingdom
-
Yuhan CorporationCompletedRheumatic ArthritisKorea, Republic of
-
Medifast, Inc.Completed
-
University of South CarolinaTerminatedSedentary Lifestyle | Knee Osteoarthritis | Knee Injuries | Knee Pain ChronicUnited States
-
University of PennsylvaniaNational Cancer Institute (NCI); PfizerCompleted
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityCompleted
-
University of Sao Paulo General HospitalCompletedOveractive Bladder SyndromeBrazil
-
Metabolic Technologies Inc.National Institute on Aging (NIA); Vanderbilt UniversityCompleted
-
Sanofi Pasteur, a Sanofi CompanyImmune DesignTerminated
-
Hanmi Pharmaceutical Company LimitedCompletedHypertensionKorea, Republic of