Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis
Interventions Behavioral: exercise
Behavioral: 2
Behavioral: Control
Enrollment 79
Recruitment Details Recruitment Sept 2005 to 2006, posters in physician offices, senior housing, recreational facilities and advertisements in local newspaper
Pre-assignment Details  
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description Continued with usual activity and care, no intervention Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility 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.
Period Title: Overall Study
Started 25 26 28
Completed 19 20 22
Not Completed 6 6 6
Reason Not Completed
Death             1             0             0
Physician Decision             3             4             2
Withdrawal by Subject             2             2             4
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education Total
Hide Arm/Group Description Continued with usual activity and care, no intervention Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility 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 of all reporting groups
Overall Number of Baseline Participants 25 26 28 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 28 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
25
 100.0%
26
 100.0%
28
 100.0%
79
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 26 participants 28 participants 79 participants
75.8  (6.2) 74.4  (7.5) 73.2  (4.8) 74.4  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 28 participants 79 participants
Female
16
  64.0%
20
  76.9%
20
  71.4%
56
  70.9%
Male
9
  36.0%
6
  23.1%
8
  28.6%
23
  29.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 25 participants 26 participants 28 participants 79 participants
25 26 28 79
1.Primary Outcome
Title Change in Balance
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT and LOCF
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description:
Continued with usual activity and care, no intervention
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
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.
Overall Number of Participants Analyzed 25 26 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (2.3) 1.2  (2.3) 1.0  (3.5)
2.Primary Outcome
Title Change in Chair Stands
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT and LOCF
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description:
Continued with usual activity and care, no intervention
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
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.
Overall Number of Participants Analyzed 25 26 28
Mean (Standard Deviation)
Unit of Measure: number of stands per 30 seconds
0.6  (1.7) 0.6  (1.7) 1.5  (2.0)
3.Primary Outcome
Title Change in Walking
Hide Description change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
Time Frame baseline and 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT and LOCF
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description:
Continued with usual activity and care, no intervention
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
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.
Overall Number of Participants Analyzed 25 26 28
Mean (Standard Deviation)
Unit of Measure: unit of scale (meters per 6 minutes)
0.3  (70.7) 14.5  (70.3) 43.3  (63.8)
4.Primary Outcome
Title Change in Falls-Efficacy
Hide Description change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
Time Frame baseline and 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT and LOCF
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description:
Continued with usual activity and care, no intervention
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
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.
Overall Number of Participants Analyzed 25 26 28
Mean (Standard Deviation)
Unit of Measure: unit of scale
2.4  (10.7) 0.8  (21.1) 5.8  (12.4)
5.Primary Outcome
Title Change in Dual Task Function
Hide Description change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
Time Frame baseline and 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description:
Continued with usual activity and care, no intervention
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
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.
Overall Number of Participants Analyzed 25 26 28
Mean (Standard Deviation)
Unit of Measure: unit of scale (seconds)
0.2  (4.3) 0.7  (3.1) 2.5  (5.1)
6.Secondary Outcome
Title Change in Physical Activity
Hide Description change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
Time Frame baseline and 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description:
Continued with usual activity and care, no intervention
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
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.
Overall Number of Participants Analyzed 25 26 28
Mean (Standard Deviation)
Unit of Measure: unit of scale
101.4  (47.3) 106.9  (50.4) 96.6  (32.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Aquatic Exercise Aquatic Exercise Plus Education
Hide Arm/Group Description Continued with usual activity and care, no intervention Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility 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.
All-Cause Mortality
Control Group Aquatic Exercise Aquatic Exercise Plus Education
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Aquatic Exercise Aquatic Exercise Plus Education
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/79 (0.00%)   0/79 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Control Group Aquatic Exercise Aquatic Exercise Plus Education
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/79 (0.00%)   0/79 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Cathy M. Arnold
Organization: University of Saskatchewan
Phone: 306 966 6588
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
First Submitted: February 7, 2006
First Posted: February 9, 2006
Results First Submitted: February 13, 2009
Results First Posted: August 3, 2010
Last Update Posted: August 3, 2010