Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000354381
Ethics application status
Approved
Date submitted
20/04/2008
Date registered
24/07/2008
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the addition of inpatient aquatic physiotherapy hasten recovery after total joint replacement surgery?
Scientific title
Does a specific inpatient aquatic physiotherapy program after joint replacement surgery improve strength more than additional ward physiotherapy or water exercise?
Secondary ID [1] 636 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip and knee arthroplasty 3078 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3234 3234 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants received standard post-operative ward physiotherapy as clinically determined by the treating physiotherapist for the first three days post-operatively. Throughout the intervention stage of the trial, from Day 4 to discharge, all participants continued to receive one ward physiotherapy treatment each day, following the standard orthopaedic clinical pathway used at the hospital. The experimental treatment was in addition to usual care. From Day 4 after surgery, participants completed one of the two aquatic treatment programs each day until discharge. All treatments were one-on-one individual physiotherapy treatment sessions to standardise intervention between the groups and also to allow close monitoring of the physiological response to immersion in the early days after surgery. The aquatic physiotherapy intervention consisted of exercises in 30% weight-bearing (chest deep water) focusing on strength using speed of movement as well as functional activities such as step ups and squats, walking forwards, backwards and sideways, balance exercises and open-chain strengthening exercises using equipment for increased resistance eg flippers. The water exercise program was undertaken in 10% weight-bearing (neck-deep water) at a slow speed and involved exercises such as marching and single-leg standing on the non-operated leg, walking forwards and general upper limb strengthening exercises. The number of additional physiotherapy treatments was recorded for all participants and on average, participants received 3.5 additional treatments while in hospital. Each treatment session lasted 40 minutes and the average length of stay was 7.5 days. The primary end-point of the trial was Day 14. After discharge home from the acute hospital and having completed the Day 14 assessments, participants were free to undertake whatever, if any, post-operative physiotherapy they chose.
Intervention code [1] 2818 0
Rehabilitation
Intervention code [2] 2819 0
Rehabilitation
Comparator / control treatment
All participants received standard post-operative ward physiotherapy as clinically determined by the treating physiotherapist for the first three days post-operatively. Throughout the intervention stage of the trial, from Day 4 to discharge, all participants continued to receive one ward physiotherapy treatment each day, following the standard orthopaedic clinical pathway used at the hospital. The control group received a second ward physiotherapy treatment each day from Day 4 until discharge. All treatments in the ward were one-on-one individual physiotherapy treatment sessions to standardise intervention between the groups.The additional ward treatment was a second session of the same exercises and included strength and range of motion exercises in supine and standing as well as mobility/gait re-education. The number of additional physiotherapy treatments was recorded for all participants and on average, participants received 3.5 additional treatments while in hospital. Each treatment session lasted 40 minutes and the average length of stay was 7 days. The primary end-point of the trial was Day 14. After discharge home from the acute hospital and having completed the Day 14 assessments, participants were free to undertake whatever, if any, post-operative physiotherapy they chose.
Control group
Active

Outcomes
Primary outcome [1] 4116 0
Hip abductor strength of operated limb, measured by hand-held dynamometer
Timepoint [1] 4116 0
pre-operatively, and then Day 14, Day 90 and Day 180 after surgery.
Primary outcome [2] 4117 0
Functional recovery measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 (V3 Australia)
Timepoint [2] 4117 0
pre-operatively, and than Day 14, Day 90 and Day 180 post-operatively
Primary outcome [3] 4118 0
Improvement in walking speed measured by the 10m walk test, timed with a stopwatch from a standing start
Timepoint [3] 4118 0
pre-operatively, and then Day 14, Day 90 and Day 180 post-operatively
Secondary outcome [1] 6929 0
Recovery of quadriceps and hamstrings strength of operated limb, measured with hand-held dynamometer
Timepoint [1] 6929 0
pre-operatively, and then Day 14, Day 90 and Day 180 post-operatively
Secondary outcome [2] 6930 0
resolution of post-operative swelling measured with a tape measure at mid-patella level and recovery of active range of motion measured using a goniometer
Timepoint [2] 6930 0
pre-operatively, and then Day 14, Day 90 and Day 180 post-operatively
Secondary outcome [3] 6931 0
recovery of functional mobility by using the time taken to complete the timed Up and Go test, timed with a stopwatch
Timepoint [3] 6931 0
pre-operatively, and then Day 14, Day 90 and Day 180 post-operatively
Secondary outcome [4] 6932 0
Return to participation in usual activities measured using the Patient-Specific Functional Measure
Timepoint [4] 6932 0
pre-operatively, and then Day 14, Day 90 and Day 180 post-operatively
Secondary outcome [5] 6933 0
Self-efficacy measured using two sub-scales of the Arthritis Self Efficacy Scale: self-efficacy to achieve outcomes and self-efficacy to manage symptoms
Timepoint [5] 6933 0
pre-operatively, and then Day 14, Day 90 and Day 180 post-operatively

Eligibility
Key inclusion criteria
all people from one orthopaedic surgery practice undergoing primary knee or hip replacement surgery for osteoarthritis in The Wesley Hospital who were able to be assessed at home before admission and lived within the Brisbane metropolitan area for follow-up after surgery
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
medically unwell day 4 post-operatively
any diagnosed neurological disorder,
had another major musculoskeletal problem that altered mobility other than the specified joint (eg low back pain, severe osteoarthritis (OA) in another lower limb joint),
cognitive dysfunction
were undergoing revision joint surgery or bilateral knee replacements.

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)
simple randomisation using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
envelopes were prepared, shuffled and numbered consecutively prior to commencement of study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3329 0
Charities/Societies/Foundations
Name [1] 3329 0
The Wesley Research Institute
Country [1] 3329 0
Australia
Primary sponsor type
Individual
Name
Ann Rahmann
Address
Physiotherapy Department
Building 84A
Services Road
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Qld 4072
Country
Australia
Secondary sponsor category [1] 2976 0
None
Name [1] 2976 0
Address [1] 2976 0
Country [1] 2976 0
Other collaborator category [1] 269 0
Individual
Name [1] 269 0
Dr Jennifer Nitz
Address [1] 269 0
Physiotherapy Department
Building 84A
Services Road
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Qld 4072
Country [1] 269 0
Australia
Other collaborator category [2] 314 0
Individual
Name [2] 314 0
Dr Sandra Brauer
Address [2] 314 0
Physiotherapy Department
Building 84A
Services Road
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, Qld 4072
Country [2] 314 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5340 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 5340 0
The Office of Research and Postgraduate Studies
Cumbrae-Stewart Bldg (72)
Building 72,
Hawken Drive
The University of Queensland
St Lucia, Qld 4072
Ethics committee country [1] 5340 0
Australia
Date submitted for ethics approval [1] 5340 0
Approval date [1] 5340 0
07/11/2002
Ethics approval number [1] 5340 0
2002000723
Ethics committee name [2] 5341 0
The Wesley Hospital Multidisciplinary Ethics Committee
Ethics committee address [2] 5341 0
The Wesley Hospital
451 Coronation Drive
Auchenflower, Qld 4066
Ethics committee country [2] 5341 0
Australia
Date submitted for ethics approval [2] 5341 0
Approval date [2] 5341 0
21/12/2002
Ethics approval number [2] 5341 0
2002/29

Summary
Brief summary
No studies to our knowledge have been published on the use of aquatic physiotherapy from Day 4 post-operatively after THR or TKR surgery. This randomised controlled trial was therefore undertaken to investigate whether inpatient aquatic physiotherapy from Day 4 in addition to usual ward physiotherapy improved early functional recovery more than non-specific water exercise or additional ward physiotherapy. The primary endpoint of the trial was Day 14. Considering the usual level of activity in healthy older people, rehabilitation to optimal function after joint replacement is usually the aim of physiotherapy. Reduced strength and gait dysfunction can persist for many months after joint replacement. If return to normal function and activity is the goal of physiotherapy intervention after joint replacement surgery, follow-up beyond the early post-acute phase is important to understand the longer term impact of early rehabilitation. Participants were therefore followed up for six months after surgery to more thoroughly gauge functional recovery.
Trial website
Trial related presentations / publications
Presented in part at the Australasian Centre on Ageing’s Emerging Researchers in Ageing Conference, December 2004, Brisbane, Australia and the Australian Physiotherapy Association’s National Aquatic Physiotherapy Symposium, August 2005, Sydney, Australia.
Public notes

Contacts
Principal investigator
Name 28546 0
Address 28546 0
Country 28546 0
Phone 28546 0
Fax 28546 0
Email 28546 0
Contact person for public queries
Name 11703 0
Ms Ann Rahmann
Address 11703 0
Physiotherapy Department
Building 84A,
Services Road,
School of Health and Rehabilitation Sciences
the University of Queensland
St Lucia, Qld 4072
Country 11703 0
Australia
Phone 11703 0
+61 7 3365 2275
Fax 11703 0
+61 7 3365 1622
Email 11703 0
[email protected]
Contact person for scientific queries
Name 2631 0
Ms Ann Rahmann
Address 2631 0
Physiotherapy Department
Building 84A,
Services Road,
School of Health and Rehabilitation Sciences
the University of Queensland
St Lucia, Qld 4072
Country 2631 0
Australia
Phone 2631 0
+61 7 3365 2275
Fax 2631 0
+61 7 3365 1622
Email 2631 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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