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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.
Scientific title
Early aquatic physiotherapy for adults following total hip and total knee replacement surgery- a randomised controlled trial.
Secondary ID [1] 288965 0
None
Universal Trial Number (UTN)
U1111-1181-7458
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis - total hip replacement and total knee replacement 298345 0
Condition category
Condition code
Musculoskeletal 298456 298456 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 298494 298494 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 294445 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 297947 0
de Morton Mobility Index - mobility and balance
Timepoint [1] 297947 0
1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
Secondary outcome [1] 322713 0
Modified Barthel Index - function/activity
Timepoint [1] 322713 0
1. Admission to subacute rehabilitation (Day 0)
2. Discharge from subacute rehabilitation (variable)
3. Six weeks after surgery (Day 42)
Secondary outcome [2] 322715 0
10 Metre Walk Test - mobility
Timepoint [2] 322715 0
1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
Secondary outcome [3] 322716 0
Timed Up and Go - mobility
Timepoint [3] 322716 0
1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
Secondary outcome [4] 322717 0
Active Lag Test - quadriceps lag
Timepoint [4] 322717 0
1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
Secondary outcome [5] 322719 0
Western Ontario and McMaster Universities Arthritis Index questionnaire - quality of life
Timepoint [5] 322719 0
1. Admission to subacute rehabilitation (Day 0)
2. Discharge from subacute rehabilitation (variable)
3. Six weeks after surgery (Day 42)
Secondary outcome [6] 322720 0
Adverse events - wound infections and inpatient falls. Adverse events will be documented retrospectively from medical records as documented by clinical staff.
Timepoint [6] 322720 0
1. Admission to subacute rehabilitation (Day 0)
2. Discharge from subacute rehabilitation (variable)
3. Six weeks after surgery (Day 42)
Secondary outcome [7] 322816 0
Hip range of movement with a goniometer
Timepoint [7] 322816 0
1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
Secondary outcome [8] 322817 0
Knee range of movement with a goniometer
Timepoint [8] 322817 0
1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable)
Secondary outcome [9] 322818 0
Number of dressing changes as recorded in the medical records (Monash Health MRK170 and MRK40 forms).
Timepoint [9] 322818 0
1. Discharge from subacute rehabilitation (variable)
Secondary outcome [10] 322819 0
Subacute length of stay (in days) as recorded in the medical records.
Timepoint [10] 322819 0
1. Discharge from subacute rehabilitation (variable)
Secondary outcome [11] 322821 0
Clinical costings based on number of wound dressings and estimated costs.
Timepoint [11] 322821 0
1. Discharge from subacute rehabilitation (variable)
Secondary outcome [12] 335286 0
Numeric Rating Scale of pain.
Timepoint [12] 335286 0
1. Admission to subacute rehabilitation (Day 0) 2. Discharge from subacute rehabilitation (variable) 3. Six weeks after surgery (Day 42)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
17/02/2017
Actual
8/03/2017
Date of last participant enrolment
Anticipated
15/11/2017
Actual
3/07/2017
Date of last data collection
Anticipated
30/12/2017
Actual
6/07/2017
Sample size
Target
60
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5587 0
Dandenong Hospital - Dandenong
Recruitment hospital [2] 5588 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 7480 0
Kingston Centre - Cheltenham
Recruitment postcode(s) [1] 13041 0
3175 - Dandenong
Recruitment postcode(s) [2] 13042 0
3165 - Bentleigh East
Recruitment postcode(s) [3] 15303 0
3192 - Cheltenham

Funding & Sponsors
Funding source category [1] 293321 0
Other Collaborative groups
Name [1] 293321 0
Lions John Cockayne Memorial Fellowship Trust Fund - Administered by Monash Health
Country [1] 293321 0
Australia
Primary sponsor type
Individual
Name
Sarah Milne
Address
Physiotherapy Department, Kingston Centre
400 Warrigal Road, Cheltenham VIC 3192
Country
Australia
Secondary sponsor category [1] 292135 0
None
Name [1] 292135 0
None
Address [1] 292135 0
None
Country [1] 292135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294793 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 294793 0
Ethics committee country [1] 294793 0
Australia
Date submitted for ethics approval [1] 294793 0
20/04/2016
Approval date [1] 294793 0
01/06/2016
Ethics approval number [1] 294793 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65066 0
Ms Sarah Milne
Address 65066 0
Physiotherapy Department
Dandenong Hospital
135 David Street
Dandenong VIC 3175
Country 65066 0
Australia
Phone 65066 0
+61 3 9554 9282
Fax 65066 0
Email 65066 0
sarah.milne@monashhealth.org
Contact person for public queries
Name 65067 0
Sarah Milne
Address 65067 0
Physiotherapy Department
Dandenong Hospital
135 David Street
Dandenong VIC 3175
Country 65067 0
Australia
Phone 65067 0
+61 3 9554 9282
Fax 65067 0
Email 65067 0
sarah.milne@monashhealth.org
Contact person for scientific queries
Name 65068 0
Sarah Milne
Address 65068 0
Physiotherapy Department
Dandenong Hospital
135 David Street
Dandenong VIC 3175
Country 65068 0
Australia
Phone 65068 0
+61 3 9554 9282
Fax 65068 0
Email 65068 0
sarah.milne@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Health and personal data was collected so not publicly available.


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.