Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000767202
Ethics application status
Approved
Date submitted
5/07/2009
Date registered
3/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of ward and aquatic exercise programs for inpatients after total hip or knee replacement using measures of pain, physiological demand and effort.
Scientific title
Inpatients after total hip or knee replacement surgery completed water exercise (day 4) aquatic physio (day 5) and ward rehab physio (day 6) and the programs were compared using measures of pain, physiological demand and effort.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total knee arthroplasty 237162 0
total hip arthroplasty 243432 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237485 237485 0 0
Physiotherapy
Musculoskeletal 239926 239926 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
On day 4 post-operatively, all participants completed a general water exercise program lasting 40 minutes, supervised by an experienced physiotherapist, in 10% weight-bearing (neck-deep water) at a slow speed, involving exercises such as marching and single-leg standing on the non-operated leg, walking forwards and general upper limb strengthening exercises. On Day 5 post-operatively, all participants completed a 40 minute specific aquatic physiotherapy program, supervised by an experienced physiotherapist, which 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 ward exercise program undertaken on Day 6 was the standard inpatient physiotherapy intervention at Day 6 following the hospital’s clinical pathway, and included gait re-education on crutches, standing strengthening exercises in parallel bars and practice of stairs in addition to bed exercises focusing on range and strength.
Intervention code [1] 236873 0
Rehabilitation
Comparator / control treatment
No control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238291 0
self-rated pain measured with the Numerical Pain Rating Scale
Timepoint [1] 238291 0
immediately before program, at 20 minutes into the program and immediately after completing each exercise program
Primary outcome [2] 238292 0
heart rate measured with a Polar Heart Rate Monitor
Timepoint [2] 238292 0
immediately before, at 5 minute intervals during the program and again immediately after completing each exercise program
Secondary outcome [1] 244666 0
Peripheral oxyhaemoglobin saturation using a fingertip pulse oximeter
Timepoint [1] 244666 0
immediately before program, at 20 minutes into the program and immediately after completing each exercise program
Secondary outcome [2] 244667 0
Systolic, diastolic and mean arterial blood pressure measured using a digital wrist blood pressure monitor
Timepoint [2] 244667 0
immediately before program, at 20 minutes into the program and immediately after completing each exercise program
Secondary outcome [3] 244668 0
temperature measured using an infra-red digital tympanic thermometer
Timepoint [3] 244668 0
immediately before program, at 20 minutes into the program and immediately after completing each exercise program
Secondary outcome [4] 244669 0
self-rated effort of each program measured using Borg's Perceived Rate of Exertion scale
Timepoint [4] 244669 0
immediately after the completion of each program
Secondary outcome [5] 244670 0
subjective perception of benefit of early aquatic physiotherapy, using 0 to 10 scale and three yes/no questions
Timepoint [5] 244670 0
at completion of final exercise program

Eligibility
Key inclusion criteria
inpatient after total hip or knee replacement
no post-operative complications
consented to participate
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diagnosed neurological disorder
any additional musculo-skeletal problem that affected mobility other than operated joint
cognitive dysfunction
had undergone bilateral knee replacements or hip resurfacing

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All participants undertook the programs in the same order so that all were naive to the water programs on their first day in the pool after surgery and could rate the easy water exercise program without having a comparison to the intensive program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1878 0
4066

Funding & Sponsors
Funding source category [1] 237263 0
Charities/Societies/Foundations
Name [1] 237263 0
Wesley Research institute
Country [1] 237263 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia
Queensland 4072
Country
Australia
Secondary sponsor category [1] 236748 0
None
Name [1] 236748 0
Address [1] 236748 0
Country [1] 236748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239364 0
University of Queensland Medical Ethics Committee
Ethics committee address [1] 239364 0
Cumbrae Stuart Building
Research Road
St Lucia
Queensland
4072
Ethics committee country [1] 239364 0
Australia
Date submitted for ethics approval [1] 239364 0
Approval date [1] 239364 0
07/11/2002
Ethics approval number [1] 239364 0
2002000723
Ethics committee name [2] 239365 0
The Wesley Hospital Multi-Disciplinary Ethics Committee
Ethics committee address [2] 239365 0
The Wesley Hospital
451 Coronation Drive
Auchenflower
Queensland
4066
Ethics committee country [2] 239365 0
Australia
Date submitted for ethics approval [2] 239365 0
Approval date [2] 239365 0
21/12/2002
Ethics approval number [2] 239365 0
2002/29

Summary
Brief summary
This study was undertaken to determine whether the two different aquatic exercise programs undertaken between Day 4 and Day 6 after joint replacement surgery were equivalent to usual ward exercise in terms of physiological demand and self-rated pain and effort. These three programs were then to be used in a larger Randomised Controlled Trial to investigate the efficacy of inpatient aquatic physiotherapy after arthroplasty. All participants undertook the programs in the same order so that all were naive to the water programs on their first day in the pool after surgery and could rate the easy water exercise program without having a comparison to the intensive program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29848 0
Address 29848 0
Country 29848 0
Phone 29848 0
Fax 29848 0
Email 29848 0
Contact person for public queries
Name 13095 0
Ann Rahmann
Address 13095 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Queensland
4072
Country 13095 0
Australia
Phone 13095 0
+61 7 3365 2275
Fax 13095 0
+61 7 3365 1622
Email 13095 0
[email protected]
Contact person for scientific queries
Name 4023 0
Ann Rahmann
Address 4023 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia
Queensland
4072
Country 4023 0
Australia
Phone 4023 0
+61 7 3365 2275
Fax 4023 0
+61 7 3365 1622
Email 4023 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
No additional documents have been identified.