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Trial registered on ANZCTR


Registration number
ACTRN12613001196730
Ethics application status
Approved
Date submitted
23/07/2013
Date registered
30/10/2013
Date last updated
30/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of group work-circuit and individualised physiotherapy treatments for orthopaedic patients: a randomised control trial
Scientific title
The effect of group work-circuit and individualised physiotherapy treatments on strength, range of movement, mobility and balance in orthopaedic patients: a randomised controlled pilot trial
Secondary ID [1] 282889 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthopaedic 289706 0
Total Knee Replacement 289707 0
Total Hip Replacement 289708 0
Hip fractures 289709 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290026 290026 0 0
Physiotherapy
Injuries and Accidents 290027 290027 0 0
Fractures
Musculoskeletal 290028 290028 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Work-circuit group based Physiotherapy for a mixed group of Orthopaedic patients.
-Exercises included balance, mobility, strengthening and range of movement exercises in a group setting. In standing, sitting and lying.
-Exercises were completed at a moderate intensity
-Frequency: Participants completed an individual circuit for 30minutes one-on-one with a Physiotherapist in the morning and a group work-circuit for 30 minutes in the afternoon. Thus 2x30min circuit exercises per day.
-Administered by a Physiotherapist and Physiotherapist Aid
-Monitor of adherence completed via medical records and an exercise sheet.
-Duration of the intervention was 12 weeks.
Intervention code [1] 287589 0
Rehabilitation
Comparator / control treatment
Individual, one-on-one Physiotherapy for a mixed group of Orthopaedic patients
-Exercises included balance, mobility, strengthening and range of movement exercises administered one-on-one. Duration of 30minutes, twice per day (AM+PM)
-Monitor of adherence completed via medical records and an exercise sheet.
-Intervention duration was 12 weeks
Control group
Active

Outcomes
Primary outcome [1] 290078 0
Increased balance and mobility
-Assessed via outcome measures of balance and mobility.
-Outcome measures used were the BERG balance scale, the Modified Elderly Mobility Scale (MEMS), the timed-up-and-go test and the 10 metre walk test.
Timepoint [1] 290078 0
12 weeks
Primary outcome [2] 290755 0
Improved function
-Impairments assessed with the following outcome measures: Visual Analogue Scale (VAS) for pain and Active Straight Leg Raise (ASLR) for quadriceps strength and function.
Timepoint [2] 290755 0
12 weeks
Secondary outcome [1] 303901 0
Cost effective rehabilitation
a) Assessed by the amount of staff needed to administer the interventions. Eg. group work circuit intervention allows one Physiotherapist and one Physiotherapist Aid (x2 staff) for 6-8 patients. Whereas one-on-one Physiotherapy intervention utilises one Physiotherapist per one patient.
Timepoint [1] 303901 0
12 weeks

Eligibility
Key inclusion criteria
Participants were in-patients of the rehabilitation ward of John Flynn Private Hospital. They had to have had a Total Hip Replacement (THR), Total Knee Replacement (TKR) or other hip pathologies/fractures. All participants had to be able to weight bear although full, partial or touch weight bearing were accepted.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants were excluded if they had surgery on both limbs, if they were non-weight bearing, if discharged directly home from the orthopaedic ward or to the day patient program, if they had a neurological condition, auto-immune disorders, unstable cardiac or cardiovascular conditions. Participants were also excluded if they werecognitively impaired, presenting with a mini-mental state examination (MMSE) score less than 24/30.

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)
Enrolling a subject occurred once they were admitted to the John Flynn Private Hospital and if they were part of the inclusion criteria.
a) Concealed allocation was achieved via central randomisation via computer for the treatment method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation was used by allocating participants to each group dependent on their bed number/letter when admitted to the John Flynn Rehabilitation Ward.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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
To maintain confidentiality, all data collected was de-identified and a coded system based on group allocation was used. The beds (and thus participants) had been randomised “A” and “B”; the data was recorded A1, B1, A2, B2 etc. This maintained confidentiality and proved effective for data entry in preparation for data analyses. The statistical software used for the analysis was SPSS version 17. Descriptive statistics included: age, gender, condition, the randomised treatment option and the length of stay in rehabilitation.

Independent samples t-test was used to test the difference between the two intervention groups. Paired t-tests were used to demonstrate within group change from the individual or group work-circuit interventions for all balance and mobility data (MEMS, BERG Test, TUG Test, 10MWT and VAS). For those variables using an ordinal scale (Mobility Aid used for the 10MWT and the TUG Test), a Wilcoxon signed rank test was used while the Sing test was used to investigate the SLR test (able/unable to SLR).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
5/01/2009
Date of last participant enrolment
Anticipated
16/03/2009
Actual
13/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 1355 0
John Flynn - Gold Coast Private Hospital - Tugun

Funding & Sponsors
Funding source category [1] 287674 0
Hospital
Name [1] 287674 0
John Flynn Private Hospital
Country [1] 287674 0
Australia
Funding source category [2] 287675 0
University
Name [2] 287675 0
Bond University
Country [2] 287675 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Faculty of Health Sciences and Medicine
14 University Drive
Robina 4226
QLD
Country
Australia
Secondary sponsor category [1] 286410 0
Hospital
Name [1] 286410 0
John Flynn Private Hospital
Address [1] 286410 0
PO Box 1
Tugun
QLD 4224
Country [1] 286410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289637 0
John Flynn Private Hospital and Medical Centre Human Research Ethics Committee
Ethics committee address [1] 289637 0
Ethics committee country [1] 289637 0
Australia
Date submitted for ethics approval [1] 289637 0
Approval date [1] 289637 0
01/01/2009
Ethics approval number [1] 289637 0
Ethics committee name [2] 289638 0
Bond University Research Ethics Committee
Ethics committee address [2] 289638 0
Ethics committee country [2] 289638 0
Australia
Date submitted for ethics approval [2] 289638 0
Approval date [2] 289638 0
01/01/2009
Ethics approval number [2] 289638 0

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

Contacts
Principal investigator
Name 41678 0
Miss Lauren Earles
Address 41678 0
Vital Health
3/117 Cunningham Street
Dalby 4405
QLD
Country 41678 0
Australia
Phone 41678 0
+61746626640
Fax 41678 0
+61746626642
Email 41678 0
dalbyphysio@vitalhealthqld.com.au
Contact person for public queries
Name 41679 0
Lauren Earles
Address 41679 0
Vital Health
Shop 3, 117 Cunningham Street
Dalby 4405
QLD
Country 41679 0
Australia
Phone 41679 0
+61746626640
Fax 41679 0
+61746626642
Email 41679 0
dalbyphysio@vitalhealthqld.com.au
Contact person for scientific queries
Name 41680 0
Nancy Low Choy
Address 41680 0
Faculty of Health Sciences
Australian Catholic University Limited (McAuley Campus)
1100 Nudgee Road, Banyo, QLD 4014.

Country 41680 0
Australia
Phone 41680 0
+61736237685
Fax 41680 0
Email 41680 0
Nancy.LowChoy@acu.edu.au

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

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