Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000096055
Ethics application status
Approved
Date submitted
22/01/2010
Date registered
1/02/2010
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Circuit class therapy for rehabilitation after stroke. A pragmatic randomised controlled trial (CIRCIT).
Scientific title
Is circuit class therapy more effective than usual care over 5 days or usual care over 7 days a week in improving six minute walk test performance in stroke survivors receiving inpatient rehabilitation after stroke?
Secondary ID [1] 1346 0
None
Universal Trial Number (UTN)
U1111-1113-4627
Trial acronym
CIRCIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 256660 0
Condition category
Condition code
Stroke 256818 256818 0 0
Ischaemic
Stroke 256819 256819 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 256820 256820 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 3-armed randomised controlled trial (RCT) to compare two methods of providing an increased amount of physical therapy during stroke rehabilitation to usual care.
Intervention 1 = Circuit class therapy. Participants will receive a target of 3 hours per day (5 days a week) of group circuit class therapy aimed at improving mobility and upper limb function. Circuit class therapy groups will be run with a staff to participant ratio of between 1:4 and 1:6. Participants in this arm of the trial will not receive individual (one-to-one) treatment sessions.
Intervention 2 = 7-day per week therapy. Participants in this arm of the trial will receive usual care physical therapy over 7-days per week. Active therapy time will be capped at 90 minutes per day.

Control arm - usual care (see further description below)

As the trial aims to compare different models of service delivery, the interventions will be provided for the duration of the participants' inpatient stay (average 6 weeks).
Intervention code [1] 255896 0
Rehabilitation
Comparator / control treatment
Usual care physical therapy. Participants in this arm of the trial will receive usual care physical therapy, 5-days a week, capped at 90 minutes of active therapy time per day. Participants will receive usual care therapy for the duration of their inpatient stay (average 6 weeks).
Control group
Active

Outcomes
Primary outcome [1] 257684 0
Walking ability (Six minute walk test)
Timepoint [1] 257684 0
2 and 4 weeks after admission to rehabilitation and at 3 and 6 months post-stroke
Secondary outcome [1] 263020 0
Walking ability (timed 10 metre walk and Functional Ambulation Classification)
Timepoint [1] 263020 0
2 and 4 weeks from start of rehabilitation and 3 and 6 months post-stroke
Secondary outcome [2] 263021 0
Ability to perform Activities of Daily Living (Functional Independence Measure)
Timepoint [2] 263021 0
2 and 4 weeks from start of rehabilitation and 3 and 6 months post-stroke
Secondary outcome [3] 263022 0
Upper limb function (Wolf Motor Function Test)
Timepoint [3] 263022 0
2 and 4 weeks from start of rehabilitation and 3 and 6 months post-stroke
Secondary outcome [4] 263023 0
Stroke Impact Scale (mobility section)
Timepoint [4] 263023 0
4 weeks from start of rehabilitation and 3 and 6 months post-stroke
Secondary outcome [5] 263024 0
Quality of life (Assessment of quality of life instrument)
Timepoint [5] 263024 0
4 weeks from start of rehabilitation and 3 and 6 months post-stroke
Secondary outcome [6] 263025 0
Participant satisfaction (Hopsat questionnaire)
Timepoint [6] 263025 0
4 weeks from start of rehabilitation and 3 and 6 months post-stroke
Secondary outcome [7] 263026 0
Complications (including adverse events). Medical records will be audited to determine the number and nature of all adverse events and new medical conditions experienced while in hospital. These will include (but are not limited to) worsening of stroke symtoms, falls (inlcuding those that do not result in injury), angina, myocardial infarction or chest infections.
Timepoint [7] 263026 0
4 weeks from start of rehabilitation and 3 and 6 months post-stroke
Secondary outcome [8] 263028 0
Length of hospital stay. This will be taken as the number of days between admission to rehabilitation and discharge from rehabilitation (as documented in the medical records).
Timepoint [8] 263028 0
at discharge from inpatient rehabilitation
Secondary outcome [9] 263029 0
Resource utilisation. Prospective data will be collected on the amount of therapist time provided to all participants as well as any other related costs such as equipment purchases etc.
Timepoint [9] 263029 0
During inpatient rehabilitation data will be prospectively collected regarding costs associated with providing the interventions.

Eligibility
Key inclusion criteria
People admitted to an inpatient rehabilitation facility with a diagnosis of stroke.
A motor Functional Independence Measure (FIM) score of between 38 and 62 points at admission to rehabilitation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who required physical assistance from another person to walk prior to their hospital admission.

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)
Participants will be allocated to groups via a phone-in centralised system off-site to the data collection sites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence generation, stratified by site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2010
Actual
21/07/2010
Date of last participant enrolment
Anticipated
Actual
25/06/2013
Date of last data collection
Anticipated
Actual
23/12/2013
Sample size
Target
282
Accrual to date
Final
283
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256384 0
Government body
Name [1] 256384 0
National Health and Medical Research Council
Country [1] 256384 0
Australia
Primary sponsor type
Individual
Name
Dr Susan Hillier
Address
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 251698 0
Individual
Name [1] 251698 0
Dr Coralie English
Address [1] 251698 0
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
Country [1] 251698 0
Australia
Secondary sponsor category [2] 251699 0
Individual
Name [2] 251699 0
Professor Maria Crotty
Address [2] 251699 0
Head of Department, Rehabilitation and Aged Care
Flinders University
PO Box 2100
Adelaide SA 5001
Country [2] 251699 0
Australia
Other collaborator category [1] 1071 0
Individual
Name [1] 1071 0
Professor Leonie Segal
Address [1] 1071 0
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
Country [1] 1071 0
Australia
Other collaborator category [2] 1072 0
Individual
Name [2] 1072 0
Associate Professor Julie Bernhardt
Address [2] 1072 0
National Stroke Research Institute
Neurosciences Building Level 1 Austin Health
300 Waterdale Rd
Heidelberg Heights
VIC 3081
Country [2] 1072 0
Australia
Other collaborator category [3] 1073 0
Individual
Name [3] 1073 0
Professor Adrian Esterman
Address [3] 1073 0
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001
Country [3] 1073 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258452 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 258452 0
Ethics committee country [1] 258452 0
Australia
Date submitted for ethics approval [1] 258452 0
Approval date [1] 258452 0
11/01/2010
Ethics approval number [1] 258452 0
P379/09
Ethics committee name [2] 258453 0
Flinders Clinical Research Ethics Committee
Ethics committee address [2] 258453 0
Ethics committee country [2] 258453 0
Australia
Date submitted for ethics approval [2] 258453 0
Approval date [2] 258453 0
22/12/2010
Ethics approval number [2] 258453 0
1/09/0377

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

Contacts
Principal investigator
Name 30756 0
A/Prof Susan Hillier
Address 30756 0
School of Health Sciences, University of South Australia
PO Box 2471
Adelaide, SA 5001
Country 30756 0
Australia
Phone 30756 0
+61 8 83022544
Fax 30756 0
Email 30756 0
[email protected]
Contact person for public queries
Name 14003 0
Susan Hillier
Address 14003 0
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide 5001
Country 14003 0
Australia
Phone 14003 0
+61 8 83022544
Fax 14003 0
+61 8 83022766
Email 14003 0
[email protected]
Contact person for scientific queries
Name 4931 0
Susan Hillier
Address 4931 0
School of Health Sciences
University of South Australia
PO Box 2471
Adelaide 5001
Country 4931 0
Australia
Phone 4931 0
+61 8 83022544
Fax 4931 0
+61 8 83022766
Email 4931 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCircuit class therapy and 7-day-week therapy increase physiotherapy time, but not patient activity: early results from the CIRCIT trial.2014https://dx.doi.org/10.1161/STROKEAHA.114.006038
EmbaseCircuit class therapy or seven-day week therapy for increasing rehabilitation intensity of therapy after stroke (CIRCIT): A randomized controlled trial.2015https://dx.doi.org/10.1111/ijs.12470
N.B. These documents automatically identified may not have been verified by the study sponsor.