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Trial registered on ANZCTR

Registration number

ACTRN12613000822785

Ethics application status

Approved

Date submitted

8/07/2013

Date registered

25/07/2013

Date last updated

11/02/2021

Date data sharing statement initially provided

11/02/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Is moderate intensity cardiovascular fitness training in addition to usual care feasible following stroke? A pilot randomized controlled trial.

Scientific title

Is moderate intensity cardiovascular fitness training in addition to usual care feasible following stroke? A pilot randomized controlled trial.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Moderate-intensity cardiovascular fitness training prescribed and supervised by a physiotherapist in the outpatient rehabilitation setting.
Frequency: 2 sessions each week; commence 5 minutes duration, progress by 2-5 minutes each session as client tolerates to a maximum of 30 minutes duration per session. Duration: 12 weeks.
Mode: Stationary bike; treadmill or overground walking; cross trainer; stepper, as deemed appropriate by physiotherapist. Intensity: Moderate intensity training will be calculated using the heart rate reserve method, or Karvonen method, where moderate-intensity is 40-59% maximum (ACSM., 2010). Target heart rate will be calculated each session. BORG-RPE and heart rate will be used to monitor moderate-intensity exercise.
Participation in home exercise program will occur concurrently with supervised sessions (ie. during same 12 week period). Participants should commence the home exercise program once deemed safe to participate in a particular mode, generally overground walking, and self-monitor their own work levels using heart rate monitoring or the BORG-RPE scale. Frequency: Weeks 1-4: 1 session; Weeks 5-8: 2 sessions; Weeks 9-12: 3 sessions, at duration consistent with supervised sessions. Participants will be provided with a weekly home exercise record with clear recommendations of mode/duration/intensity, and check boxes to record exercise completion; BORG-RPE or heart rate.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Standard low-intensity exercise program, prescribed by physiotherapist and supervised by physiotherapist or allied health assistant in outpatient rehabilitation setting.
Frequency: 2 sessions each week. Session duration will commence at 10 minutes for Weeks 1-4; progress to 20 minutes for Weeks 5-8; and 30 minutes for Weeks 9-12.
Overall Duration: 12 weeks.
Mode: general mobility and balance exercises at low intensity, including walking in rails, stationary bike, strengthening, standing balance. Intensity: Heart rate (pulse oximetry) and BORG-RPE will be monitored every 5 minutes to ensure participant is maintaining low intensity exercise (<40% HRR method).
Participation in home exercise program including low-intensity exercises prescribed from supervised program. This will commence at week 1 and continue for 12 weeks (ie. concurrent 12 weeks as supervised program)
Duration will commence at 10 minutes for Weeks 1-4; progress to 20 minutes for Weeks 5-8; and 30 minutes for Weeks 9-12. Weeks 1-4: One session; Weeks 5-8: Two sessions; Weeks 9-12: Three sessions. Participants will be provided with a weekly home exercise record with clear recommendations of exercises/repetitions/intensity monitoring, and check boxes to record exercise completion; BORG-RPE or heart rate.

Control group

Active

Outcomes

Primary outcome [1]

Cardiovascular fitness (VO2peak) - assessed by graded exercise testing (incremental exercise) using cycle ergometry. Open circuit spirometry and electrocardiography monitoring for expired gas analysis and heart rate response to determine VO2 peak. Consistent with ACSM guidelines.

Timepoint [1]

Pre and post testing ie. Testing at 0 weeks and post completion of 12 week program.

Secondary outcome [1]

Functional independence/walking speed and endurance
(six-minute walk test, 10 metre walk test (comfortable and fast speed))

Timepoint [1]

Pre and post testing (0 and 12 weeks)

Secondary outcome [2]

Quality of life (SF-36)

Timepoint [2]

Pre and post testing (0 and 12 weeks)

Secondary outcome [3]

Mood (PHQ-9)

Timepoint [3]

Pre and post testing (0 and 12 weeks)

Eligibility

Key inclusion criteria

Aged 18 years or older; diagnosed with an ischaemic or haemorrhagic stroke at least six weeks; and no more than 12 months, prior to recruitment; admitted to outpatient centre-based CBR physiotherapy at Western Health; able to walk at least 100m, with or without a gait aid or supervision from another person.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Unable to physically participate in CV exercise at low to moderate intensity; documented medical restrictions to CV training in CBR referral; unable to follow two-stage commands or indicate symptoms during exercise; pregnant;
the following comorbidities documented in their referral/medical history or GP screen: cardiovascular instability, including unstable angina, acute or complex arrhythmia; severe aortic valve disease or stenosis; severe left ventricular dysfunction; history of unstable cardiac failure or uncontrolled hypertension; pulmonary hypertension; interstitial lung disease; severe renal impairment; acute infection or fever (local or systemic); uncontrolled diabetes; recent myocardial infarction requiring acute intervention (< 6/52 prior to recruitment); acute myocarditis or pericarditis; acute pulmonary embolism or infarction; neurosurgery less than 6/52 prior to recruitment date.

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)

If deemed potentially eligible by their treating physiotherapist, potential participants will be contacted by the CI who will confirm eligibility and perform the recruitment and consent process. In the event that CI Reynolds is the treating physiotherapist for a potential participant, potential participants will be contacted by PI Skinner. Participants will be offered an interpreter if they have a non-English speaking background.
Information regarding medical history and co-morbidities will be sought from the medical history available to treating physiotherapists, and participants will be responsible for full disclosure of information on health status or previous experiences.

Prior to randomisation, participants will attend an outpatient neurology appointment with a Western Health consultant neurologist, either Dr Tissa Wijeratne or Dr Hans Tu. This appointment will enable screening of participants to ensure they are deemed medically appropriate to undergo graded exercise testing. Assessment of stroke severity will also be conducted using the NIH Stroke Scale and the Modified Rankin scale.
A medical notification form has been devised for Dr Wijeratne or Dr Tu to complete. This will be forwarded to the research team prior to randomisation. A participant will only be randomised if this form states a person is medically appropriate to undergo graded exercise testing.

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

The randomisation sequence will be generated by a third party using a randomisation table (computerised sequence generation) and allocation concealed in opaque envelopes. Randomisation will be stratified by beta blocker medication use to maximize even distribution in each group

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

29/07/2013

Actual

3/10/2013

Date of last participant enrolment

Anticipated

Actual

20/05/2016

Date of last data collection

Anticipated

Actual

15/08/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Sunshine Hospital - St Albans

Recruitment postcode(s) [1]

3021 - St Albans

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

AIMSS (Australian Institute of Musculoskeletal Science)

Address [1]

Centre for Health Research and Education
Sunshine Hospital
PO Box 294
St Albans VICTORIA
3021

Country [1]

Australia

Primary sponsor type

Individual

Name

Johanna Reynolds

Address

Sunshine Hospital
176 Furlong Road
St Albans, VIC 3021

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Community Based Rehabiliation
Western Health

Address [1]

Sunshine Hospital
PO Box 294
St Albans, VIC 3021

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research and Ethics Committee

Ethics committee address [1]

PO Royal Melbourne Hospital
Parkville
Victoria 3050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/06/2013

Approval date [1]

16/07/2013

Ethics approval number [1]

2013.105

Summary

Brief summary

This project is a pilot randomised controlled trial. The main aim is to test whether it is possible to recruit and follow trial procedures in addition to working out how much benefit may come from the treatment in order to make sure enough participants are recruited for a future large randomised controlled trial. The main hypothesis is that adding cardiovascular (or fitness) training to normal rehabilitation in people who have had a stroke will be possible to do and safe for the patient. The next aim is to test the effect of the fitness training on cardiovascular fitness, walking speed and endurance; quality of life (QOL) and depression. 
The objective of the future randomised controlled trial will be to determine whether the moderate-intensity CV training program significantly improves the defined outcomes compared to ‘usual’ rehabilitation care.
The trial will be run in an outpatient rehabilitation service of a tertiary public hospital in metropolitan Melbourne. People will be eligible to be in the trial if they have been diagnosed with a stroke more than six weeks prior; are over 18 years old; able to walk by themselves with or without a gait aid or supervision of another person; and do not have medical or other limitations to exercise. Participants currently taking medications that may affect heart rate response to exercise will be included in the trial. 20 people will be selected to receive either the treatment or normal care. People measuring outcomes won't know which group the patient is in. All participants will be tested for fitness (VO2 peak); walking speed; and quality of life and depression.
The treatment group will receive two supervised sessions of moderate-intensity fitness training each week for twelve weeks. Exercise will commence at 10 minutes, and progress incrementally, as tolerated, to 30 mintues duration, prior to progression of exercise intensity. Progression of duration and intensity will be determined by trained physiotherapists, using the Karvonen method (ACSM 2010). People will either exercise with a recumbent or standard stationary bike, treadmill, stepper or cross-trainer. Participants currently taking heart rate control medications will utilise a scale of how hard they are working to monitor exercise intensity. A home exercise program of CV training will be prescribed, and gradually increased in frequency.  People should progress to doing a total of 150 minutes of CV exercise in weeks 9-12 of the trial, as recommended by the NHF guidelines for aerobic exercise (Briffa et al 2006).  

People assigned to the usual rehab group will receive two sessions per week of a  light strengthening and balance exercise program. These participants will have heart rate monitoring at five-minute intervals to maintain low-intensity exercise. Session length will be progressed from 10 minutes for 4 weeks, to 20 minutes for 4 weeks, and 30 minutes for final 4 weeks. A general home exercise program will also be given to this group.

Trial website

Trial related presentations / publications

Smart Strokes Conference presentation 2017

Public notes

Contacts

Principal investigator

Name

Ms Johanna Reynolds

Address

Community Based Rehabiliation
Sunshine Hospital
PO Box 294
St Albans VICTORIA
3021

Country

Australia

Phone

+61439384724

Fax

+61 3 83451339

[email protected]

Contact person for public queries

Name

Johanna Reynolds

Address

Community Based Rehabilitation
Sunshine Hospital
PO Box 294
St Albans VIC
3021

Country

Australia

Phone

+61439384724

Fax

+61 3 83451339

[email protected]

Contact person for scientific queries

Name

Johanna Reynolds

Address

Community Based Rehabiliation
Sunshine Hospital
PO Box 294
St Albans VIC
3021

Country

Australia

Phone

+61439384724

Fax

+61 3 83451339

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	Feasibility and adherence to moderate intensity cardiovascular fitness training following stroke: a pilot randomized controlled trial.	2021	https://dx.doi.org/10.1186/s12883-021-02052-8

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

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Documents added automatically