Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000647336
Ethics application status
Approved
Date submitted
1/05/2017
Date registered
4/05/2017
Date last updated
28/05/2019
Date data sharing statement initially provided
28/05/2019
Date results provided
28/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pedaling-Based Protocol Superior to a Ten-Exercise, Non-Pedaling Protocol for Postoperative Rehabilitation Following Total Knee Replacement: A Randomized Controlled Trial.
Scientific title
Pedaling-Based Protocol Superior to a Ten-Exercise, Non-Pedaling Protocol for Postoperative Rehabilitation Following Total Knee Replacement: A Randomized Controlled Trial.
Secondary ID [1] 291811 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 303053 0
Osteoarthritis 303076 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302510 302510 0 0
Physiotherapy
Musculoskeletal 302534 302534 0 0
Osteoarthritis
Surgery 302535 302535 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention or "Pedalling" group will be given a modified physiotherapy protocol with the main exercise being stationary pedalling on a set of floor pedals, it will also include gait retraining and walking as well as a knee extension (straightening) stretch. A senior orthopaedic physiotherapist will be delivering both the Intervention and Control group physiotherapy protocols. In the hospital setting, the twice daily 20-minute physiotherapy session will consist of 2 exercises (pedalling and a knee extension stretch, gait retraining & aid prescription and practice of functional activities such as transfers and stair climbing. 8 minutes will be dedicated to the bike pedalling activity, 2 minutes to the extension stretch, and the other 10 minutes towards gait retraining and achievement of functional goals for discharge such as independent transfers and mobility. Once discharged the patient will continue with this home exercise program twice daily for 20 minutes and will be given a diary to tick off daily to calculate compliance, they are asked to return the diary to the assessor at their 2-week review. As patients will be independent with transfers and mobility on discharge, an increased time can be spent on their home exercise program which consists of the same exercises in hospital and should be split, 10 minutes on pedalling, 5 minutes of knee extension stretching, and 5 minutes spent on gait training with an emphasis on heel-toe strike.

Both the Intervention and Control groups will commence physiotherapy on the day of surgery and undergo the same twice daily inpatient physiotherapy sessions post total knee replacement surgery, the time of each session will be approximately 20 minutes. This is no different than the standard frequency and duration of current inpatient physiotherapy sessions. Patients are instructed not to see an outpatient physiotherapist between discharge and their 2 week follow up assessment.
Intervention code [1] 297925 0
Rehabilitation
Comparator / control treatment
The Control or "Multi-exercise" group will be given a standard multi­-exercise physiotherapy program which includes seated knee bends, Inner range knee strengthening exercise and functional strength exercises such as mini squats and calf raises. The control group will also be given the knee extension stretch and gait­ retraining, however, they will not be given any stationary pedalling exercises. A senior orthopaedic physiotherapist will be delivering both the Intervention and Control group physiotherapy protocols. The 20 minute session for the control group will consist of 10 minutes dedicated to the mult-exercise handout which is the same as their on-going 2 week home exercise program. The other 10 minutes will be spent on gait retraining and achievement of functional goals for discharge such as independent transfers and mobility. Once discharged the patient will continue with this home exercise program twice daily for 20 minutes and will be given a diary to tick off daily to calculate compliance, they are asked to return the diary to the assessor at their 2-week review. As patients will be independent with transfers and mobility on discharge, an increased time can be spent on their home exercise program which consists of the same exercises in hospital and should be split, 15 minutes on multi-exercise handout and 5 minutes spent on gait training with an emphasis on heel-toe strike.


Both the Intervention and Control groups will commence physiotherapy on the day of surgery and undergo the same twice daily inpatient physiotherapy sessions post total knee replacement surgery, the time of each session will be approximately 20 minutes. This is no different than the standard frequency and duration of current inpatient physiotherapy sessions. Patients are instructed not to see an outpatient physiotherapist between discharge and their 2 week follow up assessment.
Control group
Active

Outcomes
Primary outcome [1] 301923 0
6 minute walk test
Timepoint [1] 301923 0
2 days, 2 weeks, and 4 months post TKR surgery
Secondary outcome [1] 334279 0
Timed Up and Go 3 meter walk test
Timepoint [1] 334279 0
2 days, 2 weeks, and 4 months post TKR surgery
Secondary outcome [2] 334280 0
Oxford Knee Score
Timepoint [2] 334280 0
2 days, 2 weeks, and 4 months post TKR surgery
Secondary outcome [3] 334281 0
Knee flexion ROM
Timepoint [3] 334281 0
2 days, 2 weeks, and 4 months post TKR surgery.
Secondary outcome [4] 334282 0
Analgesia Consumption, recorded by review of the medication chart from the patient's hospital medical record. Specifically, Oxycodone which is prescribed for "breakthrough" pain relief, and is prescribed as "PRN" or "as needed".
Timepoint [4] 334282 0
From time of TKR surgery to discharge from acute hospital ward
Secondary outcome [5] 334283 0
Pain Threshold self-reported Likert Scale
Timepoint [5] 334283 0
2 days post TKR Surgery
Secondary outcome [6] 334284 0
Patient Satisfaction with Physiotherapy self-reported Likert scale
Timepoint [6] 334284 0
2 days and 2 weeks post TKR surgery
Secondary outcome [7] 334354 0
"Time at which the patient is deemed safe for discharge" this is routinely decided by the orthopaedic physiotherapist at our institution and is dependent on the achievement of the following functional goals:
Independent transfers
Independent mobility (with aid for discharge)
Completed stairs practice
Achieved 90 degrees knee flexion at any point during post-operative hospital stay
Timepoint [7] 334354 0
Measured in days from day of surgery to day of discharge from the acute hospital setting.
Secondary outcome [8] 370863 0
10 meter timed walk test
Timepoint [8] 370863 0
2 days, 2 weeks and 4 months post TKR surgery
Secondary outcome [9] 370864 0
Euroquol 5 Dimensions (EQ5D) Health Outcome Measure Questionnaire
Timepoint [9] 370864 0
2 days, 2 weeks and 4 months post TKR surgery

Eligibility
Key inclusion criteria
Patients of one particular Orthopaedic Surgeon at our Institution undergoing primary unilateral total knee replacement surgery with a primary diagnosis of osteoarthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have a history of a mental illness or a condition which would interfere with the patient’s ability to understand the requirements of the study. This may include, but is not limited to, a history of dementia or short-­term memory impairment. Participants will also be excluded if they have a predisposition to be discharged to an inpatient rehabilitation (or hostel) facility due to lack of social support (for example, the patient would otherwise return home with no carer availability) or other physical impairment that would mean they could not perform a home exercise program without “hands­on” assistance.
Participants will also be excluded if they have a physical condition following surgery that makes them unable to participate in testing, i.e an extreme nauseous reaction following anaesthesia or a severe medical complication that would limit mobility such as a pulmonary embolism, or syncopal event.

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)
Sealed opaque envelope, carried out by Surgeon's practice Nurse, who is otherwise not involved in any other aspect of this trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised Sequence Generation: Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
60 participants (30 in each group) is based on the existing research publication "The immediate and long­term effects of a walking­ skill program compared to usual physiotherapy care in patients who have undergone total knee arthroplasty (TKA): a randomised controlled trial" (Bruun­Olsen V, Heiberg KE, Wahl AK, Mengshoel AM. The immediate and long­term effects of a walking­skill program compared to usual physiotherapy care in patients who have undergone total knee arthroplasty (TKA): a randomised controlled trial. Disabil Rehabil.2013;35(23):2008–15.
doi: 10.3109/09638288.2013.770084.)
In total, this study included 57 patients in its analysis, 29 in the walking­skill group and 28 in the usual physiotherapy care group, in the primary outcome measure, 6MWT, a statistically significant difference in change scores between the two groups was seen. In addition, further sample size estimates will be calculated using G­Power, utilising the appropriate primary outcome measure.

The quantitative data will be analysed using the Statistical Package SPSS. A repeated measures ANOVA (analysis of variance) will be utilized to assess the relevant and specific outcome measures across the data collection time points of 3 days, 12 days, and 4 months postoperatively. Additional post hoc comparisons and analysis will be utilised where appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
6/06/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
21/11/2017
Date of last data collection
Anticipated
1/04/2018
Actual
16/04/2018
Sample size
Target
60
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7899 0
Pindara Private Hospital - Benowa
Recruitment postcode(s) [1] 15857 0
4217 - Benowa

Funding & Sponsors
Funding source category [1] 296314 0
University
Name [1] 296314 0
Bond University
Country [1] 296314 0
Australia
Primary sponsor type
Individual
Name
Larissa Sattler
Address
Senior Orthopaedic Physiotherapist
Pindara Private Hospital
Allchurch Avenue
Benowa 4217 QLD
Country
Australia
Secondary sponsor category [1] 295240 0
University
Name [1] 295240 0
Bond University
Address [1] 295240 0
14 University Dr, Robina QLD 4226
Country [1] 295240 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297543 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 297543 0
Ethics committee country [1] 297543 0
Australia
Date submitted for ethics approval [1] 297543 0
12/05/2016
Approval date [1] 297543 0
01/08/2016
Ethics approval number [1] 297543 0
15631
Ethics committee name [2] 297547 0
Greenslopes Research and Ethics Committee
Ethics committee address [2] 297547 0
Ethics committee country [2] 297547 0
Australia
Date submitted for ethics approval [2] 297547 0
10/08/2016
Approval date [2] 297547 0
05/10/2016
Ethics approval number [2] 297547 0
16/49

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1671 1671 0 0
/AnzctrAttachments/372832-BUHREC Approval Letter.pdf (Ethics approval)
Attachments [2] 1672 1672 0 0
/AnzctrAttachments/372832-PARTICIPANT EXPLANATORY FORM (Final).docx (Participant information/consent)
Attachments [3] 1673 1673 0 0
/AnzctrAttachments/372832-PARTICIPANT INFORMED CONSENT FORM (Final).docx (Participant information/consent)

Contacts
Principal investigator
Name 74386 0
Ms Larissa Sattler
Address 74386 0
Senior Orthopaedic Physiotherapist
Pindara Private Hospital
Allchurch Avenue, Benowa
QLD 4217
Country 74386 0
Australia
Phone 74386 0
+61755889125
Fax 74386 0
Email 74386 0
[email protected]
Contact person for public queries
Name 74387 0
Larissa Sattler
Address 74387 0
Senior Orthopaedic Physiotherapist
Pindara Private Hospital
Allchurch Avenue, Benowa
QLD 4217
Country 74387 0
Australia
Phone 74387 0
+61755889125
Fax 74387 0
Email 74387 0
[email protected]
Contact person for scientific queries
Name 74388 0
Larissa Sattler
Address 74388 0
Senior Orthopaedic Physiotherapist
Pindara Private Hospital
Allchurch Avenue, Benowa
QLD 4217
Country 74388 0
Australia
Phone 74388 0
+61755889125
Fax 74388 0
Email 74388 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified demographic data of participants
Individual de-identified results data of participants
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following manuscript publication
Available to whom?
Researchers who provide a methodologically sound proposal in writing to the Authors
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access will be subject to approval by the Authors, and there will be a requirement to sign data access agreement


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.