Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000863336
Ethics application status
Approved
Date submitted
2/06/2017
Date registered
13/06/2017
Date last updated
26/04/2019
Date data sharing statement initially provided
26/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Are three shorter sessions of physiotherapy each therapy day more effective than one longer session in improving the mobility of patients admitted to a rehabilitation ward after hip fracture?
Scientific title
A new model of physiotherapy rehabilitation to improve outcomes after hip fracture; a randomised trial to establish if three shorter sessions of physiotherapy each therapy day are more effective than one longer session in improving the mobility of patients admitted to a rehabilitation ward after hip fracture
Secondary ID [1] 292065 0
Nil known
Universal Trial Number (UTN)
U1111-1197-0477
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fractured hip 303474 0
Condition category
Condition code
Injuries and Accidents 302885 302885 0 0
Fractures
Physical Medicine / Rehabilitation 302973 302973 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study investigates a new model of physiotherapy rehabilitation for patients admitted to inpatient rehabilitation at the Peter James Centre after surgery for a fractured hip. It is a randomised controlled trial consisting of an intervention group and a control group. The intervention group will receive 3x 15 minute sessions of physiotherapy 5 days/week and the control group will receive usual care of 1x 45 minute session of physiotherapy 5 days/week. This will commence after admission to inpatient rehabilitation and continue until discharge from inpatient rehabilitation. The physiotherapy for both groups will consist of walking practice, therapeutic exercises and functional task practice. Only frequency and duration of sessions will be different between the two groups. Physiotherapy treatment records will be used to assess fidelity/compliance and content of the program. Separate physiotherapists and allied health assistants with a range of experience levels will independently deliver the program to the intervention and control groups. Information sessions and training will be provided to these staff by the principal researcher. Any new staff commencing during the study period will also be trained. Adherence to the protocol will be ensured by the principal researcher with weekly physiotherapy treatment record checks.
Intervention code [1] 298203 0
Rehabilitation
Intervention code [2] 298282 0
Treatment: Other
Comparator / control treatment
As described above, the control group will have usual care, which is 1x 45 minutes session of physiotherapy 5 days/week.
Control group
Active

Outcomes
Primary outcome [1] 302273 0
De Morton Mobility Index (DEMMI) score
Timepoint [1] 302273 0
The primary timepoint is at discharge from inpatient rehabilitation. It will also be measured at admission and 2 weeks into inpatient stay
Secondary outcome [1] 335333 0
Daily Functional Independence Measure (FIM) score for ambulation
Timepoint [1] 335333 0
Measured daily during admission to the inpatient rehabilitation unit and recorded in the physiotherapy treatment record which is added to the medical record
Secondary outcome [2] 335334 0
Length of stay in the acute hospital (days)
Timepoint [2] 335334 0
This information will be obtained from the medical record at discharge from the acute hospital
Secondary outcome [3] 335335 0
Discharge destination eg.; back to prior residence, need for extra assistance, transition care program, respite or new placement in residential care
Timepoint [3] 335335 0
This information will be obtained from the discharge summary in the medical record
Secondary outcome [4] 335336 0
Total amount of walking daily as determined by an ActivPAL 3 activity monitor
Timepoint [4] 335336 0
measured for 7 days from the start of 2nd week of admission to the rehabilitation unit.
Secondary outcome [5] 335337 0
Compliance with the protocol as recorded in the physiotherapy treatment record ie did they participate in all sessions as planned according to their treatment group
Timepoint [5] 335337 0
recorded daily during entire admission to the rehabilitation unit
Secondary outcome [6] 335338 0
Patient satisfaction with the intervention as determined by a survey. This survey was designed for the study and is attached to the original ANZCTR record.
Timepoint [6] 335338 0
The participant or their next of kin will complete this on the day of their discharge from the inpatient rehabilitation unit.
Secondary outcome [7] 335339 0
Adverse events for both groups eg falls, infections, death
Timepoint [7] 335339 0
This information will be obtained from the medical record- searching from admission to the inpatient rehabilitation unit up until 1 month post discharge
Secondary outcome [8] 335723 0
FIM score for transfers (composite score)
Timepoint [8] 335723 0
This will be recorded daily in the physiotherapy treatment record throughout their admission to inpatient rehabilitation
Secondary outcome [9] 335724 0
FIM score for stairs
Timepoint [9] 335724 0
This will be recorded daily in the physiotherapy treatment record throughout their admission to inpatient rehabilitation
Secondary outcome [10] 335725 0
Length of stay in inpatient rehabilitation (days)
Timepoint [10] 335725 0
This information will be obtained from the medical record at discharge from inpatient rehabilitation
Secondary outcome [11] 335726 0
30 day readmission rate to hospital
Timepoint [11] 335726 0
This information will be obtained from the medical record- it will be recorded if the patient has been readmitted to Eastern Health in the first 30 days after discharge from inpatient rehabilitation
Secondary outcome [12] 335829 0
Staff satisfaction with the intervention method as determined by a survey. This was designed for the study and is attached to the original ANZCTR record.
Timepoint [12] 335829 0
The surveys will be collected at the end of the study period- end of July 2018.

Eligibility
Key inclusion criteria
Admitted to the rehabilitation unit at Peter James Centre
Primary diagnosis of fractured hip
No co-current injuries
Over 50 years of age
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not allowed to weight bear after surgery for the fractured hip
co-current injuries eg other fractures, brain injury, cardiac event sustained at the same time as the fractured hip

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)
Yes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with a concealed method, using permuted block design with a computer random number generator (www.randomization.com) using sealed opaque envelopes prepared by an independent researcher with no role in recruitment or assessment. Only after the participant has enrolled in the trial and completed written informed consent and baseline testing will assignment to the group be made
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation
The primary dependent variable of the de Morton Mobility Index (DEMMI) was used to determine sample size. Based on a previous study in this population and setting power at 80% and alpha at 5%, a sample size of 72 patients is required, 36 in each group to detect a clinically significant difference of 6 points in the DEMMI assuming a standard deviation of 8.9 (de Morton et al 2013).
76 participants will be recruited as 76 randomization envelopes were generated by a separate researcher. We decided to go ahead with this sample. A greater sample may be helpful if there are unexpected drops outs/ incomplete data.
Data analyses
Intention to treat analysis will be performed for all participants in the study using all available data. Between group differences of primary and continuous secondary outcomes will be analysed with ANCOVA using the baseline measures as covariates. The proportion of participants in each group achieving a minimally important change in mobility (DEMMI greater than or equal to 6 points) will be analysed with relative risk rations. Categorical secondary outcomes will be analysed with Pearson chi square or risk ratios as appropriate. Survey data will be analysed descriptively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/07/2017
Actual
4/09/2017
Date of last participant enrolment
Anticipated
1/08/2018
Actual
25/06/2018
Date of last data collection
Anticipated
1/09/2018
Actual
19/07/2018
Sample size
Target
76
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8200 0
Peter James Centre - Forest Hill
Recruitment postcode(s) [1] 16259 0
3131 - Forest Hill

Funding & Sponsors
Funding source category [1] 296598 0
Hospital
Name [1] 296598 0
Eastern Health- Rehabilitation Unit Peter James Centre
Country [1] 296598 0
Australia
Primary sponsor type
Individual
Name
Ms Catherine Senserrick
Address
Physiotherapy Department
Peter James Centre
321-345 Burwood Hwy
Forest Hill
Victoria 3131
Country
Australia
Secondary sponsor category [1] 295553 0
Individual
Name [1] 295553 0
Professor Nicholas Taylor
Address [1] 295553 0
Research Department
Eastern Health
Level 2/ 5 Arnold St
Box Hill
Victoria 3128
Country [1] 295553 0
Australia
Secondary sponsor category [2] 295568 0
Individual
Name [2] 295568 0
Dr Genevieve Kennedy
Address [2] 295568 0
Director of Rehabilitation
Eastern Health
321-345 Burwood Hwy
Forest Hill
Victoria 3131
Country [2] 295568 0
Australia
Secondary sponsor category [3] 295569 0
Individual
Name [3] 295569 0
Mr Grant Scroggie
Address [3] 295569 0
Associate Director of Allied Health (Physiotherapy)
Eastern Health
321-345 Burwood Hwy
Forest Hill
Victoria 3131
Country [3] 295569 0
Australia
Other collaborator category [1] 279588 0
Individual
Name [1] 279588 0
Ms Kim Williams
Address [1] 279588 0
Physiotherapy Subacute Program Manager
Eastern Health
321-345 Burwood Hwy
Forest Hill
Victoria 3131
Country [1] 279588 0
Australia
Other collaborator category [2] 279589 0
Individual
Name [2] 279589 0
Ms Kate Lawler
Address [2] 279589 0
Acting Physiotherapy Subacute Program Manager
Eastern Health
321-345 Burwood Hwy
Forest Hill
Victoria 3131
Country [2] 279589 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297825 0
Eastern Health
Ethics committee address [1] 297825 0
Ethics committee country [1] 297825 0
Australia
Date submitted for ethics approval [1] 297825 0
21/11/2016
Approval date [1] 297825 0
25/05/2017
Ethics approval number [1] 297825 0
E21-2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1762 1762 0 0
/AnzctrAttachments/373035-HREC E21-2016 Final Approval 290517.pdf (Ethics approval)
Attachments [2] 1763 1763 0 0
/AnzctrAttachments/373035-PROTOCOL - Clean Copy v3 230517.docx (Protocol)
Attachments [3] 1764 1764 0 0
/AnzctrAttachments/373035-4. PICF - Clean Copy.docx (Participant information/consent)
Attachments [4] 1775 1775 0 0
/AnzctrAttachments/373035-Participant Survey.docx (Other)
Attachments [5] 1776 1776 0 0
/AnzctrAttachments/373035-Therapist Survey.docx (Other)

Contacts
Principal investigator
Name 75198 0
Ms Catherine Senserrick
Address 75198 0
Physiotherapy Department
Peter James Centre
321-345 Burwood Hwy
Forest Hill
Victoria 3131
Country 75198 0
Australia
Phone 75198 0
+61 3 98811845
Fax 75198 0
Email 75198 0
[email protected]
Contact person for public queries
Name 75199 0
Catherine Senserrick
Address 75199 0
Physiotherapy Department
Peter James Centre
321-345 Burwood Hwy
Forest Hill
Victoria 3131
Country 75199 0
Australia
Phone 75199 0
+61 3 98811845
Fax 75199 0
Email 75199 0
[email protected]
Contact person for scientific queries
Name 75200 0
Catherine Senserrick
Address 75200 0
Physiotherapy Department
Peter James Centre
321-345 Burwood hwy
Forest Hill
Victoria 3131
Country 75200 0
Australia
Phone 75200 0
+61 3 98811845
Fax 75200 0
Email 75200 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 participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it,
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Supplementary file of manuscript after accepted for publication.


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
SourceTitleYear of PublicationDOI
EmbaseThree short sessions of physiotherapy during rehabilitation after hip fracture were no more effective in improving mobility than a single longer session: a randomised controlled trial.2021https://dx.doi.org/10.1016/j.physio.2020.12.002
N.B. These documents automatically identified may not have been verified by the study sponsor.