Trial Outcomes & Findings for Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis (NCT NCT00289458)
NCT ID: NCT00289458
Last Updated: 2010-08-03
Results Overview
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
79 participants
Primary outcome timeframe
baseline and 11 weeks
Results posted on
2010-08-03
Participant Flow
Recruitment Sept 2005 to 2006, posters in physician offices, senior housing, recreational facilities and advertisements in local newspaper
Participant milestones
| Measure |
Control Group
Continued with usual activity and care, no intervention
|
Aquatic Exercise
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
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 Study
STARTED
|
25
|
26
|
28
|
|
Overall Study
COMPLETED
|
19
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
Reasons for withdrawal
| Measure |
Control Group
Continued with usual activity and care, no intervention
|
Aquatic Exercise
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
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 Study
Death
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
4
|
Baseline Characteristics
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
Baseline characteristics by cohort
| Measure |
Control Group
n=25 Participants
Continued with usual activity and care, no intervention
|
Aquatic Exercise
n=26 Participants
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
n=28 Participants
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
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
79 Participants
n=31 Participants
|
|
Age Continuous
|
75.8 years
STANDARD_DEVIATION 6.2 • n=39 Participants
|
74.4 years
STANDARD_DEVIATION 7.5 • n=41 Participants
|
73.2 years
STANDARD_DEVIATION 4.8 • n=35 Participants
|
74.4 years
STANDARD_DEVIATION 6.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=39 Participants
|
20 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
56 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
23 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=39 Participants
|
26 participants
n=41 Participants
|
28 participants
n=35 Participants
|
79 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: baseline and 11 weeksPopulation: ITT and LOCF
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
Outcome measures
| Measure |
Control Group
n=25 Participants
Continued with usual activity and care, no intervention
|
Aquatic Exercise
n=26 Participants
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Balance
|
0.2 units on a scale
Standard Deviation 2.3
|
1.2 units on a scale
Standard Deviation 2.3
|
1.0 units on a scale
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: baseline and 11 weeksPopulation: ITT and LOCF
change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
Outcome measures
| Measure |
Control Group
n=25 Participants
Continued with usual activity and care, no intervention
|
Aquatic Exercise
n=26 Participants
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Chair Stands
|
0.6 number of stands per 30 seconds
Standard Deviation 1.7
|
0.6 number of stands per 30 seconds
Standard Deviation 1.7
|
1.5 number of stands per 30 seconds
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: baseline and 11 weeksPopulation: ITT and LOCF
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
Outcome measures
| Measure |
Control Group
n=25 Participants
Continued with usual activity and care, no intervention
|
Aquatic Exercise
n=26 Participants
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Walking
|
0.3 unit of scale (meters per 6 minutes)
Standard Deviation 70.7
|
14.5 unit of scale (meters per 6 minutes)
Standard Deviation 70.3
|
43.3 unit of scale (meters per 6 minutes)
Standard Deviation 63.8
|
PRIMARY outcome
Timeframe: baseline and 11 weeksPopulation: ITT and LOCF
change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
Outcome measures
| Measure |
Control Group
n=25 Participants
Continued with usual activity and care, no intervention
|
Aquatic Exercise
n=26 Participants
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Falls-Efficacy
|
2.4 unit of scale
Standard Deviation 10.7
|
0.8 unit of scale
Standard Deviation 21.1
|
5.8 unit of scale
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: baseline and 11 weekschange in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
Outcome measures
| Measure |
Control Group
n=25 Participants
Continued with usual activity and care, no intervention
|
Aquatic Exercise
n=26 Participants
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Dual Task Function
|
0.2 unit of scale (seconds)
Standard Deviation 4.3
|
0.7 unit of scale (seconds)
Standard Deviation 3.1
|
2.5 unit of scale (seconds)
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: baseline and 11 weekschange in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
Outcome measures
| Measure |
Control Group
n=25 Participants
Continued with usual activity and care, no intervention
|
Aquatic Exercise
n=26 Participants
Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
|
Aquatic Exercise Plus Education
n=28 Participants
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.
|
|---|---|---|---|
|
Change in Physical Activity
|
101.4 unit of scale
Standard Deviation 47.3
|
106.9 unit of scale
Standard Deviation 50.4
|
96.6 unit of scale
Standard Deviation 32.7
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aquatic Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aquatic Exercise Plus Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place