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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289458

Enrollment

Registered

2006-02-09

Start date

2005-10-31

Completion date

2008-04-30

Last updated

2010-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Keywords

older adults, falls, arthritis, aquatic, exercise

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.

Interventions

BEHAVIORALexercise

A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.

BEHAVIORAL2

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.

BEHAVIORALControl

no exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in Physical Activity	baseline and 11 weeks	change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)

Countries

Canada

Participant flow

Recruitment details

Recruitment Sept 2005 to 2006, posters in physician offices, senior housing, recreational facilities and advertisements in local newspaper

Participants by arm

Arm	Count
Control Group Continued with usual activity and care, no intervention	25
Aquatic Exercise Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility	26
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.	28
Total	79

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Death	1	0	0
Overall Study	Physician Decision	3	4	2
Overall Study	Withdrawal by Subject	2	2	4

Baseline characteristics

Characteristic	Aquatic Exercise	Aquatic Exercise Plus Education	Control Group	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	26 Participants	28 Participants	25 Participants	79 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age Continuous	74.4 years STANDARD_DEVIATION 7.5	73.2 years STANDARD_DEVIATION 4.8	75.8 years STANDARD_DEVIATION 6.2	74.4 years STANDARD_DEVIATION 6.3
Region of Enrollment Canada	26 participants	28 participants	25 participants	79 participants
Sex: Female, Male Female	20 Participants	20 Participants	16 Participants	56 Participants
Sex: Female, Male Male	6 Participants	8 Participants	9 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 79	0 / 79	0 / 79
serious Total, serious adverse events	0 / 79	0 / 79	0 / 79

Outcome results

Primary

Change in Balance

Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)