ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1113-4627

Trial acronym

CIRCIT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Physical Medicine / Rehabilitation

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]

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]

Walking ability (Six minute walk test)

Timepoint [1]

2 and 4 weeks after admission to rehabilitation and at 3 and 6 months post-stroke

Secondary outcome [1]

Walking ability (timed 10 metre walk and Functional Ambulation Classification)

Timepoint [1]

2 and 4 weeks from start of rehabilitation and 3 and 6 months post-stroke

Secondary outcome [2]

Ability to perform Activities of Daily Living (Functional Independence Measure)

Timepoint [2]

2 and 4 weeks from start of rehabilitation and 3 and 6 months post-stroke

Secondary outcome [3]

Upper limb function (Wolf Motor Function Test)

Timepoint [3]

2 and 4 weeks from start of rehabilitation and 3 and 6 months post-stroke

Secondary outcome [4]

Stroke Impact Scale (mobility section)

Timepoint [4]

4 weeks from start of rehabilitation and 3 and 6 months post-stroke

Secondary outcome [5]

Quality of life (Assessment of quality of life instrument)

Timepoint [5]

4 weeks from start of rehabilitation and 3 and 6 months post-stroke

Secondary outcome [6]

Participant satisfaction (Hopsat questionnaire)

Timepoint [6]

4 weeks from start of rehabilitation and 3 and 6 months post-stroke

Secondary outcome [7]

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]

4 weeks from start of rehabilitation and 3 and 6 months post-stroke

Secondary outcome [8]

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]

at discharge from inpatient rehabilitation

Secondary outcome [9]

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]

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?

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Dr Coralie English

Address [1]

School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Professor Maria Crotty

Address [2]

Head of Department, Rehabilitation and Aged Care
Flinders University
PO Box 2100
Adelaide SA 5001

Country [2]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor Leonie Segal

Address [1]

School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Associate Professor Julie Bernhardt

Address [2]

National Stroke Research Institute
Neurosciences Building Level 1 Austin Health
300 Waterdale Rd
Heidelberg Heights
VIC 3081

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Professor Adrian Esterman

Address [3]

School of Health Sciences
University of South Australia
PO Box 2471
Adelaide, SA 5001

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

Research and Innovation Services
University of South Australia
Mawson Lakes Campus
Mawson Lakes Boulevard
Mawson Lakes SA 5095

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/01/2010

Ethics approval number [1]

P379/09

Ethics committee name [2]

Flinders Clinical Research Ethics Committee

Ethics committee address [2]

Room 2A221 
Flinders Medical Centre 
Bedford Park SA 5042

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

22/12/2010

Ethics approval number [2]

1/09/0377

Summary

Brief summary

Loss of independence is common following stroke, and may lead to reduced quality of life. We will investigate if an increased amount of physical rehabilitation following stroke leads to improvements in walking ability, arm function and independence. Two ways of providing an increased amount of physical rehabilitation will be compared to usual care to find out which leads to improved physical mobility and how they compare economically. 
The key hypotheses are:
1. Compared to usual care therapy (5 days a week), group circuit class therapy (provided 5 days a week for 3 hours per day) will lead to improvements in walking function and mobility.
2. Compared to usual care therapy (5 days a week) providing physical therapy over 7 days a week will lead to improvements in walking function and mobility.
3. Compared to 7-day a week therapy, group circuit class therapy (5 days a week) will lead to improvements in walking function and mobility.
4. Group circuit class therapy will be more cost-effective than 7-day week therapy.

Trial website

Trial related presentations / publications

Van Kessel G, Hiller S and English C (2017) Physiotherapists’ attitudes towards circuit class therapy and 7 day per week therapy is influenced by normative beliefs, past experience and perceived control: a qualitative study Physiotherapy Theory and Practice  33(11): 850-858 https://doi.org/10.1080/09593985.2017.1357152

English C, Shields N, Brusco NK, Taylor NF, Watts JJ, Peiris C, Bernhardt J, Crotty M, Esterman A, Segal L, Hillier S (2016) Additional weekend therapy may reduce length of rehabilitation stay after stroke: a meta-analysis of individual patient data. Journal of Physiotherapy Vol 62, Issue 3,pp. 124-129. 

Bennett L, Luker J, English C, Hillier S (2015) Stroke survivors’ perspectives on two novel models of inpatient rehabilitation: seven-day a week individual therapy or five-day a week circuit class therapy. Disability and Rehabilitation Nov 24:1-10 

English C, Bernhardt J, Crotty M, Esterman A, Segal L and Hillier S (2015) Circuit class therapy or 7-day week therapy for increasing rehabilitation intensity of therapy after stroke (CIRCIT). A randomised controlled trial. International Journal of Stroke 10: 594-602  DOI:10.1111/ijs.12470

English C, Bernhardt J and Hillier S (2014) Circuit class therapy and 7-day-week therapy increase physiotherapy time, but not patient activity. Early results from the CIRCIT trial. Stroke 45:3002-7. DOI: 10.1161/STROKEAHA.114.006038 

English C, Hillier S, Kaur G and Hundertmark L (2014)“Stroke survivors spend more time in active task practice, but similar time in walking practice when physiotherapy is provided in circuit classes versus individual therapy sessions.” Journal of Physiotherapy 60:50-54 http://dx.DOI.org/10.1016/j.jphys.2013.12.006

“Circuit Class Therapy and 7-Day Week Therapy for Increasing Rehabilitation Intensity of Therapy. Results of the CIRCIT Trial” Stroke 2014 Stroke Society of Australasia Annual Scientific Meeting, Hamilton Island July 31-Aug 2nd 2014

English C, Shields N,  Brusco N, Taylor N, Watts J, Peiris C, Bernhardt J, Crotty M, Esterman A, Hillier S “Does weekend therapy reduce length of rehabilitation hospital stay for people with stroke? An individual patient data meta-analysis.” World Congress of NeuroRehabilitation Philadelphia, USA May 10-12th 2016

English C, Bernhardt J, Crotty M, Esterman A, Hillier S “Time spent in physiotherapy sessions during sub-acute rehabilitation does not predict recovery of walking ability.” European Stroke Organisation Conference, Glasgow, UK April 17-19 2015 (POSTER)

Hillier S, English C, Bernhardt J, Crotty M, Esterman  A, Segal L “Circuit class and 7-day week therapy for increasing rehabilitation intensity of therapy after stroke (CIRCIT): Six month follow-up and cost analysis of the CIRCIT RCT  9th World Stroke Congress, Istanbul, Turkey, October 22-25, 2014. International Journal of Stroke 2014 9:22

Public notes

Contacts

Principal investigator

Name

A/Prof Susan Hillier

Address

School of Health Sciences, University of South Australia
PO Box 2471
Adelaide, SA 5001

Country

Australia

Phone

+61 8 83022544

Fax

susan.hillier@unisa.edu.au

Contact person for public queries

Name

Susan Hillier

Address

School of Health Sciences
University of South Australia
PO Box 2471
Adelaide 5001

Country

Australia

Phone

+61 8 83022544

Fax

+61 8 83022766

susan.hillier@unisa.edu.au

Contact person for scientific queries

Name

Susan Hillier

Address

School of Health Sciences
University of South Australia
PO Box 2471
Adelaide 5001

Country

Australia

Phone

+61 8 83022544

Fax

+61 8 83022766

susan.hillier@unisa.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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Circuit class therapy and 7-day-week therapy increase physiotherapy time, but not patient activity: early results from the CIRCIT trial.	2014	https://dx.doi.org/10.1161/STROKEAHA.114.006038
Embase	Circuit class therapy or seven-day week therapy for increasing rehabilitation intensity of therapy after stroke (CIRCIT): A randomized controlled trial.	2015	https://dx.doi.org/10.1111/ijs.12470

N.B. These documents automatically identified may not have been verified by the study sponsor.

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