Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000147280
Ethics application status
Approved
Date submitted
22/01/2009
Date registered
12/03/2009
Date last updated
16/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial on the effects of Aqua Aerobics on improving the falls risk and physical function in older adults with lower extremity osteoarthirits
Scientific title
A randomised controlled trial on the effects of Aqua Aerobics on improving the falls risk and physical function in older adults with lower extremity osteoarthirits
Secondary ID [1] 288173 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls risk in older adults with lower extremity osteoarthritis 4224 0
Older adults with lower extremity osteoarthritis 4225 0
Condition category
Condition code
Physical Medicine / Rehabilitation 4443 4443 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aqua aerobics, 60 minute sessions, twice weekly for 12 weeks. The aqua aerobics sessions will comprise activities standing and walking in the pool that challenge balance strategies and increase the strength of the lower limbs.
Intervention code [1] 3942 0
Other interventions
Comparator / control treatment
Computer Skill Training Programme, 60 minute sessions, twice weekly for 12 weeks. The Computer Skill Training Programme is run by a voluntary organisation catering for older adults known as SeniorNet. During the sessions participants practice their computer skills and roving advisors assist each individual at what ever level of computer skills they are presently at.
Those participants not interested in computer training can engage in card or board games provided on the same time schedule (60 minute sessions, twice weekly for 12 weeks). These board and card games are organised by an organisation catering for older adults and comprise activities such as mah-jong.
Control group
Active

Outcomes
Primary outcome [1] 5324 0
Physiological Profile Assessment short form battery test
Timepoint [1] 5324 0
baseline and post-intervention: week 13, week 25, 6 months
Primary outcome [2] 5325 0
Activity-specific Balance Confidence Scale
Timepoint [2] 5325 0
baseline and post-intervention: week 13, week 25, 6 months
Primary outcome [3] 5326 0
Step test
Timepoint [3] 5326 0
baseline and post-intervention: week 13, week 25, 6 months
Secondary outcome [1] 8953 0
WOMAC questionnaire
Timepoint [1] 8953 0
baseline and post-intervention: week 13, week 25, 6 months
Secondary outcome [2] 8954 0
Arthritis Impact Measurement Scales
Timepoint [2] 8954 0
baseline and post-intervention: week 13, week 25, 6 months
Secondary outcome [3] 8955 0
Falls incidence will be assessed with the use of monthly falls diaries. Participants will note on the appropriate day in the diary if they have a fall. Diaries are returned monthly to the researchers whether the individual has fallen or not. Participants not returning diaries are reminded each month by a telephone call. Participants indicating they have had a fall are contacted to obtain details of the fall using a structured questionnaire.
Timepoint [3] 8955 0
Monthly for the first 15 months starting from baseline.
Secondary outcome [4] 8956 0
Timed up and Go
Timepoint [4] 8956 0
baseline and post-intervention: week 13, week 25, 6 months
Secondary outcome [5] 8957 0
Programme Acceptability interview
Timepoint [5] 8957 0
1 week post-intervention

Eligibility
Key inclusion criteria
- Over the age of 65 years (55 years +Maori/Pacific)
- At least one risk factor for falls as assessed by the Falls Risk Assessment Tool (FRAT).
- Osteoarthritis of the lower limb will be determined, using Western Ontario and McMaster Universities Osteoarthritis Index score (WOMAC),14 by clinical criteria, PAIN: "mild" on 2 items or "moderate" on 1 item; PHYSICAL FUNCTION: "mild" difficulty in 4 items or "moderate" difficulty in 2 items.
- All participants will require general practitioner medical clearance.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to ambulate independently
- Chronic medical condition that would limit participation in moderate intensity exercise
- Severe cognitive limitations (as determined by the telephone Mini-Mental State Examination)
- Hip or knee replacement in the past 6 months
- Current participation in an exercise programme aimed at improving strength and balance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the Dunedin area through community organisations catering for older adults (e.g. Age Concern, Grey Power), doctor and physiotherapy practices, churches and public media advertising. Interested volunteers will contact the researchers. Eligibility for inclusion into the trial will be conducted by telephone interview using a standardised study eligibility questionnaire with volunteers responding to the study advertising. People who met the inclusion criteria and agree to participate will be invited for a baseline assessment. At this time informed written consent will be gained. Following the baseline assessments, participants will be randomly assigned to either Aqua aerobics or Computer Training (waiting list control arm) using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random numbers system
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/03/2009
Date of last participant enrolment
Anticipated
16/06/2010
Actual
16/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
39
Recruitment outside Australia
Country [1] 1544 0
New Zealand
State/province [1] 1544 0
Dunedin

Funding & Sponsors
Funding source category [1] 4406 0
Charities/Societies/Foundations
Name [1] 4406 0
Lottery Health
Country [1] 4406 0
New Zealand
Primary sponsor type
Individual
Name
Dr Leigh Hale
Address
School of Physiotherapy
University of Otago
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 3965 0
Individual
Name [1] 3965 0
Dr Debra Waters
Address [1] 3965 0
Preventive and Social Medicine
University of Otago
PO Box 913
Dunedin
9054
Country [1] 3965 0
New Zealand
Other collaborator category [1] 537 0
Individual
Name [1] 537 0
Peter Herbison
Address [1] 537 0
Preventive and Social Medicine
University of Otago
PO Box 913
Dunedin
9054
Country [1] 537 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6455 0
University of Otago Ethical Committee
Ethics committee address [1] 6455 0
Ethics committee country [1] 6455 0
New Zealand
Date submitted for ethics approval [1] 6455 0
Approval date [1] 6455 0
08/01/2009
Ethics approval number [1] 6455 0
08/008

Summary
Brief summary
Osteoarthritis (OA) is the most common form of arthritis, presenting in almost half of all people over the age of 60 and nearly all people over the age of 80. Lower extremity osteoarthritis in older adults is associated with functional losses, reduced daily physical activity and increased falls risk. Public health exercise programmes aimed at reducing falls risk in older adults are provided in New Zealand but are land-based, and potentially aggravate the signs and symptoms associated with arthritis. Aqua aerobics may be a suitable alternative form of fall prevention exercise for older adults with OA at risk of falling. This randomised control trial with six month follow-up will investigate whether a twelve week, twice weekly aqua aerobics programme decreases falls risk and improves measures of gait, balance and physical function in older adults with osteoarthritis who have a heightened risk of falling.
Trial website
Trial related presentations / publications
(1) Hale L, Waters D, Herbison PA. A randomised controlled trial to investigate the effects of water-based exercise to improve falls risk and physical function in older adults with lower extremity osteoarthritis. Archives of Physical Medicine and Rehabilitation 2012; 93: 27-34.

(2) Moody J, Hale L, Waters D. Perceptions of a water-based exercise programme to improve physical function and falls risk in older adults with lower extremity osteoarthritis: barriers, motivators and sustainability. New Zealand Journal of Physiotherapy, 2012, 40(2): 64-70.
Public notes

Contacts
Principal investigator
Name 29209 0
A/Prof Leigh Hale
Address 29209 0
School of Physiotherapy, University of Otago, PO Box 56, Dunedin
Country 29209 0
New Zealand
Phone 29209 0
+64 3 479 5425
Fax 29209 0
Email 29209 0
leigh.hale@otago.ac.nz
Contact person for public queries
Name 12456 0
A/Prof Dr Leigh Hale
Address 12456 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin
9054
Country 12456 0
New Zealand
Phone 12456 0
+64 3 479 5425
Fax 12456 0
+ 64 3 479 8414
Email 12456 0
leigh.hale@otago.ac.nz
Contact person for scientific queries
Name 3384 0
A/Prof Dr Leigh Hale
Address 3384 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin
9054
Country 3384 0
New Zealand
Phone 3384 0
+64 3 479 5425
Fax 3384 0
+ 64 3 479 8414
Email 3384 0
leigh.hale@otago.ac.nz

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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