ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000205639

Ethics application status

Approved

Date submitted

2/09/2013

Date registered

26/02/2014

Date last updated

26/02/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

Promoting physical activity after stroke via self management: A feasibility trial

Scientific title

Promoting physical activity after stroke via self management: A feasibility trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

PPASS Feasibility

Linked study record

Health condition

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

Individuals following acute stroke, living in the community

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will be self-management. Self-management involves the stroke survivor (and family/carers as appropriate) working in partnership with their health care provider, both via face to face visits and telephone discussions. The intervention will be delivered in 5 face to face visits of 60-90 minutes duration, with phone discussions as required by the partipant, over a three month period, and will commence within the first month following discharge. The visits will occur 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks after discharge from hospital. Intervention will consist of the following:
1. Education about the importance of exercise
2. Medical clearance to exercise
3. Negotiation of an exercise plan with stroke survivor, family and carers
4. Problem solution, support and encouragement to take up exercise
5. Monitoring and support of behaviour change
Follow-up will occur at 3 months and 6 months. Adherence to protocol will be documented with each face to face visit.

Intervention code [1]

Lifestyle

Intervention code [2]

Rehabilitation

Comparator / control treatment

Not applicable - single group feasibility study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Physical activity levels during waking hours over 1 week using the bodymedia Sensewear armband (amount of physcial activity (mins) and number of steps/day).

Timepoint [1]

Baseline, post-intervention (3 months), follow-up (6 months)

Secondary outcome [1]

Waist circumference (cm) using a tape measure at the level of the umbilicus.

Timepoint [1]

Baseline, post-intervention (3 months), Follow-up (6 months)

Secondary outcome [2]

Adverse events: injurious falls, non-injurious falls, muscle soreness and/or fatigue, hospitalisation and/or death will be self-reported by the participant/carer on a daily calendar.

Timepoint [2]

Assessed on a daily basis during the 3 month intervention period

Secondary outcome [3]

weight (kg) using electronic scales

Timepoint [3]

Baseline, post-intervention (3 months), follow-up (6 months)

Secondary outcome [4]

Blood pressure (mmHg) using an electronic blood pressure machine

Timepoint [4]

Baseline, Post-intervention (3 months), follow-up (6months)

Secondary outcome [5]

6 minute walk test (m)

Timepoint [5]

Baseline, post-intervention (3 months) and follow-up (6 months)

Secondary outcome [6]

10m walk test (speed (m/s); stride length (cm))

Timepoint [6]

Baseline, Post-intervention (3 months), follow-up (6 months)

Secondary outcome [7]

EuroQOL 5D to measure health state

Timepoint [7]

Baseline, Post-intervention (3 months) and follow-up (6 months)

Secondary outcome [8]

A modified version of the IPAQ will be used to measure participation restrictions

Timepoint [8]

Baseline, Post-intervention (3 months) and follow-up (6 months)

Secondary outcome [9]

Self-Efficacy for exercise scale

Timepoint [9]

Baseline, Post-intervention (3 months) and follow-up (6 months)

Secondary outcome [10]

Feasibility of recruitment through calculation of the number of patients screened, eligible and enrolled.

Timepoint [10]

Follow-up (6 months)

Secondary outcome [11]

Feasibility of intervention measured via participant adherence with the intervention

Timepoint [11]

Post-intervention (3 months)

Secondary outcome [12]

Feasibility of the measurement protocol through the time taken to administer

Timepoint [12]

Baseline, Post-intervention (3 months) and Follow-up (6 months)

Eligibility

Key inclusion criteria

Patients after stroke who are:
1. To be discharged home from an acute medical/stroke unit within one month of stroke onset
2. Able to walk 10m across flat ground without an aid at greater than or equal to 0.8m/s. (12.5s on 10MWT)
3. Score greater than or equal to 24 on the Mini Mental State Examination

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

A score of greater than or 25/30 on Frenchay Screening Aphasia test

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Single group feasiblity study

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This is a feasibility study, so no between group differences will be detected. If the intervention is demonstrated to be feasible, then this study will be used to make a power calculation for a large scale RCT.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

14/10/2013

Actual

21/10/2013

Date of last participant enrolment

Anticipated

31/12/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT

Recruitment hospital [1]

The Canberra Hospital - Garran

Recruitment postcode(s) [1]

2605 - Garran

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canberra

Address [1]

Discipline of Physiotherapy
Faculty of Health
Building 12
Moana St
Bruce ACT 2617

Country [1]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

Discipline of Physiotherapy
Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Ldcombe NSW 1825

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

The Canberra Hospital

Address [1]

GPO Box 825
Canberra City ACT 2601

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Canberra

Address [2]

Discipline of Physiotherapy
Faculty of Health
Building 12
Moana St Bruce
ACT 2617

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee

Ethics committee address [1]

ACT Health
GPO Box 825
Canberra City ACT 2601

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/04/2013

Ethics approval number [1]

ETHLR.13.063

Ethics committee name [2]

The University of Sydney Human Research Ethics Committee

Ethics committee address [2]

Faculty of Health Sciences
Cumberland Campus C42
The University of Sydney
PO Box 170
Lidcombe NSW 1825

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

15/07/2013

Ethics approval number [2]

2013.629

Ethics committee name [3]

Macquarie University Human Research Ethics Committee

Ethics committee address [3]

Macquarie University 
Balaclava Road
North Ryde NSW 2109

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

19/06/2013

Ethics approval number [3]

5201300469

Summary

Brief summary

To determine the feasibility and efficacy of 3 months of self-management support for increasing physical activity in people with mild disability after stroke

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Cath Dean

Address

Discipline of Physiotherapy
Macquarie University
Ground floor 75 Talavera Road
Ryde NSW 2109

Country

Australia

Phone

+61 2 9850 6620

Fax

[email protected]

Contact person for public queries

Name

Elisabeth Preston

Address

Discipline of Physiotherapy
Faculty of Health
University of Canberra
Moana St Bruce
ACT 2617

Country

Australia

Phone

+61 2 62015749

Fax

[email protected]

Contact person for scientific queries

Name

Cath Dean

Address

Discipline of Physiotherapy
Macquarie University
Ground floor 75 Talavera Road
Ryde NSW 2109

Country

Australia

Phone

+61 2 9850 6620

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Promoting physical activity after stroke via self-management: A feasibility study.	2017	https://dx.doi.org/10.1080/10749357.2017.1304876

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

Trial Review

Documents added manually

Documents added automatically