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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
8/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of moderate-intensity cardiovascular fitness training compared to standard care in people with a diagnosis of stroke: a pilot randomised controlled trial
Scientific title
The effect of moderate-intensity cardiovascular fitness training compared to standard care on VO2peak in people with a diagnosis of stroke: a pilot randomised controlled trial
Secondary ID [1] 282781 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 289543 0
Condition category
Condition code
Stroke 289865 289865 0 0
Haemorrhagic
Stroke 289866 289866 0 0
Ischaemic
Physical Medicine / Rehabilitation 289917 289917 0 0
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] 287454 0
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] 289927 0
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] 289927 0
Pre and post testing ie. Testing at 0 weeks and post completion of 12 week program.
Secondary outcome [1] 303584 0
Functional independence/walking speed and endurance
(six-minute walk test, 10 metre walk test (comfortable and fast speed))
Timepoint [1] 303584 0
Pre and post testing (0 and 12 weeks)
Secondary outcome [2] 303594 0
Quality of life (SF-36)
Timepoint [2] 303594 0
Pre and post testing (0 and 12 weeks)
Secondary outcome [3] 303595 0
Mood (PHQ-9)
Timepoint [3] 303595 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1200 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 7062 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 287554 0
Other Collaborative groups
Name [1] 287554 0
AIMSS (Australian Institute of Musculoskeletal Science)
Address [1] 287554 0
Centre for Health Research and Education
Sunshine Hospital
PO Box 294
St Albans VICTORIA
3021
Country [1] 287554 0
Australia
Primary sponsor type
Individual
Name
Johanna Reynolds
Address
Sunshine Hospital
176 Furlong Road
St Albans, VIC 3021
Country
Australia
Secondary sponsor category [1] 286304 0
Hospital
Name [1] 286304 0
Community Based Rehabiliation
Western Health
Address [1] 286304 0
Sunshine Hospital
PO Box 294
St Albans, VIC 3021
Country [1] 286304 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289531 0
Melbourne Health Human Research and Ethics Committee
Ethics committee address [1] 289531 0
PO Royal Melbourne Hospital
Parkville
Victoria 3050
Ethics committee country [1] 289531 0
Australia
Date submitted for ethics approval [1] 289531 0
28/06/2013
Approval date [1] 289531 0
16/07/2013
Ethics approval number [1] 289531 0
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
Public notes

Contacts
Principal investigator
Name 41214 0
Ms Johanna Reynolds
Address 41214 0
Community Based Rehabiliation
Sunshine Hospital
PO Box 294
St Albans VICTORIA
3021
Country 41214 0
Australia
Phone 41214 0
+61 3 83451282
Fax 41214 0
+61 3 83451339
Email 41214 0
hanna.reynolds@wh.org.au
Contact person for public queries
Name 41215 0
Ms Johanna Reynolds
Address 41215 0
Community Based Rehabilitation
Sunshine Hospital
PO Box 294
St Albans VIC
3021
Country 41215 0
Australia
Phone 41215 0
+61 3 83451282
Fax 41215 0
+61 3 83451339
Email 41215 0
hanna.reynolds@wh.org.au
Contact person for scientific queries
Name 41216 0
Ms Johanna Reynolds
Address 41216 0
Community Based Rehabiliation
Sunshine Hospital
PO Box 294
St Albans VIC
3021
Country 41216 0
Australia
Phone 41216 0
+61 3 83451282
Fax 41216 0
+61 3 83451339
Email 41216 0
hanna.reynolds@wh.org.au

No information has been provided regarding IPD availability
Summary results
No Results