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Trial registered on ANZCTR
Registration number
ACTRN12616000494437
Ethics application status
Approved
Date submitted
8/04/2016
Date registered
15/04/2016
Date last updated
6/12/2018
Date data sharing statement initially provided
6/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Early aquatic physiotherapy after total hip and total knee replacement surgery.
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Scientific title
Early aquatic physiotherapy for adults following total hip and total knee replacement surgery- a randomised controlled trial.
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Secondary ID [1]
288965
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None
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Universal Trial Number (UTN)
U1111-1181-7458
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis - total hip replacement and total knee replacement
298345
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Condition category
Condition code
Musculoskeletal
298456
298456
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0
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Osteoarthritis
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Physical Medicine / Rehabilitation
298494
298494
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will be early commencement of aquatic physiotherapy (six days) following total hip and total knee replacement surgery. This will occur during a standard subacute rehabilitation stay. Participants will undergo a standardised wound dressing procedure to ensure wounds have appropriate and safe waterproof cover. Participants will be provided with an ‘individualised’ program, based on the initial physical assessment performed by the treating physiotherapist, as per usual clinical care. All components of the intervention will be individualised according to the participant's clinical requirement, as per standard practice. This will include duration and frequency of exercises, exercises selected and number of aquatic physiotherapy sessions. The aquatic exercises will be provided by a subacute physiotherapist. All exercises will be individually documented, including use of properties of water, such as depth of water, buoyancy, turbulence and hydrostatic pressure.
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Intervention code [1]
294445
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Rehabilitation
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Comparator / control treatment
The control group will commence aquatic physiotherapy approximately 14 days post-surgery, which is current standard practice. Participants will be provided with an ‘individualised’ program, based on the initial physical assessment performed by the treating physiotherapist, as per usual clinical care. The aquatic exercises will be provided by a subacute physiotherapist. All exercises will be individually documented, including use of properties of water, such as depth of water, buoyancy, turbulence and hydrostatic pressure.
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Control group
Active
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Outcomes
Primary outcome [1]
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de Morton Mobility Index - mobility and balance
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Assessment method [1]
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Timepoint [1]
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1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
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Secondary outcome [1]
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Modified Barthel Index - function/activity
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Assessment method [1]
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Timepoint [1]
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1. Admission to subacute rehabilitation (Day 0)
2. Discharge from subacute rehabilitation (variable)
3. Six weeks after surgery (Day 42)
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Secondary outcome [2]
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10 Metre Walk Test - mobility
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Assessment method [2]
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Timepoint [2]
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1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
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Secondary outcome [3]
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Timed Up and Go - mobility
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Assessment method [3]
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Timepoint [3]
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1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
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Secondary outcome [4]
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Active Lag Test - quadriceps lag
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Assessment method [4]
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Timepoint [4]
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1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
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Secondary outcome [5]
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Western Ontario and McMaster Universities Arthritis Index questionnaire - quality of life
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Assessment method [5]
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Timepoint [5]
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1. Admission to subacute rehabilitation (Day 0)
2. Discharge from subacute rehabilitation (variable)
3. Six weeks after surgery (Day 42)
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Secondary outcome [6]
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Adverse events - wound infections and inpatient falls. Adverse events will be documented retrospectively from medical records as documented by clinical staff.
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Assessment method [6]
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Timepoint [6]
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1. Admission to subacute rehabilitation (Day 0)
2. Discharge from subacute rehabilitation (variable)
3. Six weeks after surgery (Day 42)
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Secondary outcome [7]
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Hip range of movement with a goniometer
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Assessment method [7]
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Timepoint [7]
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1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
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Secondary outcome [8]
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Knee range of movement with a goniometer
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Assessment method [8]
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Timepoint [8]
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1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
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Secondary outcome [9]
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Number of dressing changes as recorded in the medical records (Monash Health MRK170 and MRK40 forms).
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Assessment method [9]
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Timepoint [9]
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1. Discharge from subacute rehabilitation (variable)
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Secondary outcome [10]
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Subacute length of stay (in days) as recorded in the medical records.
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Assessment method [10]
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Timepoint [10]
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1. Discharge from subacute rehabilitation (variable)
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Secondary outcome [11]
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Clinical costings based on number of wound dressings and estimated costs.
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Assessment method [11]
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Timepoint [11]
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1. Discharge from subacute rehabilitation (variable)
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Secondary outcome [12]
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Numeric Rating Scale of pain.
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Assessment method [12]
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Timepoint [12]
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1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable) 3. Six weeks after surgery (Day 42)
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Eligibility
Key inclusion criteria
1. Undergone elective total hip or total knee replacement surgery at Dandenong or Moorabbin Hospitals
2. Able to provide informed consent to participate.
3. Admitted to Kingston Centre or Dandenong Hospital for subacute inpatient rehabilitation within 6 days of elective total hip or total knee replacement surgery.
4. Classified as a 'Monash Health Pathway C patient'.or 'Monash Health Pathway B patient'.
5. Received surgery from a Monash Health surgeon consenting for participant to participate in the study.
6. Willing to attend an appointment at Moorabbin or Dandenong Hospital, or Kingston Centre for the 6-week assessment.
7. Aged 18 years and above.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Unable to provide informed consent to participate due to cognitive impairment or delirium.
2. Undergone non-elective total hip or total knee replacement surgery.
3. Received surgery from a Monash Health surgeon not consenting for participant to participate in the study.
4. Has a medical condition that precludes immersion in a hydrotherapy pool, such as severe cardiac disease.
5. Wound is oozing, unable to be adequately covered and/or is better to be left uncovered for optimal healing.
6. Pregnancy.
7. Undergone revision of a total hip or knee replacement surgery, bilateral total hip or knee replacement or unicompartmental knee replacement.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent person will generate the set of random numbers which will be used to create an allocation sequence. The random numbers will be contained in individual opaque envelopes for use by the research team members to assign participants to the two groups.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each eligible participant will be randomised using permuted blocks with stratification by joint, via a computer generated set of random numbers, to the early immersion ‘intervention’ group or to the standard care ‘control’ group.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The primary outcome measure for the randomised controlled trial will be the de Morton Mobility Index (DEMMI). The DEMMI will be compared between groups with a repeated measures ANOVA with the fixed effects factor variables of Group and Time. Subacute length of stay and overall (acute and subacute) length of stay will be compared between groups using an independent-samples t-tests if the data is normally distributed or Mann-Whitney U tests if it is not normally distributed. Other outcome measures will be compared between groups using a repeated measures ANOVA. The primary intervention effect will be estimated along with 95% confidence interval levels.
A cost-benefit analysis calculation will be carried out to determine the cost-effectiveness of the early immersion. Variables included in this calculation will be wound dressings, staffing costs and inpatient admission costs. The significance level will be recorded as 0.05 (a=0.05). Statistical analysis will be performed using STATA (Version 14; Stata Corporation, College Station, Texas, USA).
A power analysis for an independent sample t-test was conducted to determine a sufficient sample size using an alpha of 0.05, a power of 0.80, a medium to large effect size (d = 0.7). There will be an equal allocation of participants into each group. Based on these assumptions, the desired sample size in each group is 30 participants.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
17/02/2017
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Actual
8/03/2017
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Date of last participant enrolment
Anticipated
15/11/2017
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Actual
3/07/2017
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Date of last data collection
Anticipated
30/12/2017
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Actual
6/07/2017
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Sample size
Target
60
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Accrual to date
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Final
6
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
5587
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Dandenong Hospital - Dandenong
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Recruitment hospital [2]
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Monash Medical Centre - Moorabbin campus - East Bentleigh
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Recruitment hospital [3]
7480
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Kingston Centre - Cheltenham
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Recruitment postcode(s) [1]
13041
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3175 - Dandenong
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Recruitment postcode(s) [2]
13042
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3165 - Bentleigh East
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Recruitment postcode(s) [3]
15303
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3192 - Cheltenham
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Funding & Sponsors
Funding source category [1]
293321
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Other Collaborative groups
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Name [1]
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Lions John Cockayne Memorial Fellowship Trust Fund - Administered by Monash Health
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Address [1]
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Kingston Centre
400 Warrigal Road
Cheltenham VIC 3192
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Sarah Milne
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Address
Physiotherapy Department, Kingston Centre
400 Warrigal Road, Cheltenham VIC 3192
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
292135
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None
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Country [1]
292135
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash Health Human Research Ethics Committee
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Ethics committee address [1]
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Monash Medical Centre 246 Clayton Road Clayton VIC 3168
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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20/04/2016
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Approval date [1]
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01/06/2016
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Ethics approval number [1]
294793
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Summary
Brief summary
Aquatic Physiotherapy has been shown to improve the ability of people to move and function following total hip and knee replacement surgery. The primary aim of this study is to examine if early commencement of aquatic physiotherapy (6 days after surgery) improves function, as compared to standard commencement of aquatic physiotherapy (typically 14 days after surgery- once the wound has healed). Patients attending undergoing total hip replacement or total knee replacement surgery at Dandenong or Moorabbin Hospital who require in-hospital rehabilitation at Dandenong Hospital or the Kingston Centre will be recruited to participate in a randomised controlled trial. One group of participants will receive aquatic physiotherapy 6 days following surgery (intervention), whilst the other group will wait 14 days to commence aquatic physiotherapy as per standard practice (control). A total of 60 people will be randomly assigned to one of these groups. The main measure used to evaluate the intervention will be the de Morton Mobility Index, a measure of walking and balance. A range of other measures will also be administered to evaluate the effect of early aquatic physiotherapy on the ability to function, length of hospital stay, pain, walking speed, quality of life, cost of wound dressings and presence of wound infections. These outcome measures will be assessed at baseline, on discharge from rehabilitation. Function, pain, quality of life, function and presence of wound infections will also be assessed at 6 weeks following surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Sarah Milne
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Address
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Physiotherapy Department
Dandenong Hospital
135 David Street
Dandenong VIC 3175
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Country
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Australia
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Phone
65066
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+61 3 9554 9282
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Fax
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Email
65066
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[email protected]
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Contact person for public queries
Name
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Sarah Milne
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Address
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Physiotherapy Department
Dandenong Hospital
135 David Street
Dandenong VIC 3175
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Country
65067
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Australia
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Phone
65067
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+61 3 9554 9282
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Fax
65067
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Email
65067
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[email protected]
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Contact person for scientific queries
Name
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Sarah Milne
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Address
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Physiotherapy Department
Dandenong Hospital
135 David Street
Dandenong VIC 3175
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Country
65068
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Australia
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Phone
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+61 3 9554 9282
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Fax
65068
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Email
65068
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Health and personal data was collected so not publicly available.
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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.
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