Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000050651p
Ethics application status
Not yet submitted
Date submitted
9/01/2023
Date registered
16/01/2023
Date last updated
16/01/2023
Date data sharing statement initially provided
16/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Verifying if aerobic training protocols benefit the heart in subacute stroke
Scientific title
Feasibility of high-intensity interval training in subacute stroke: a pilot trial
Secondary ID [1] 308704 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 328637 0
Condition category
Condition code
Stroke 325646 325646 0 0
Ischaemic
Stroke 325647 325647 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 325648 325648 0 0
Physiotherapy
Physical Medicine / Rehabilitation 325649 325649 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study, we will conduct a pilot RCT testing the feasibility, safety and acceptability of High Intensity Interval Training (HIIT) (Intervention) compared to Moderate Intensity Continuous Training (MICT) (Control) during stroke rehabilitation. An allied health clinician (i.e., Physiotherapist or Exercise Physiologist) will implement 10 weeks of individually tailored aerobic training three times per week as per national and international guidelines. Participants will be randomly assigned to either HIIT or MICT. For HIIT, the program will be delivered in small groups of 2-4 participants in a rehabilitation gym using recumbent steppers, treadmills or bicycle ergometers depending on individual capability. Specifically, if the person is able to walk 10m with less than minimal physical assistance, they will begin training using a treadmill. Otherwise, they will use the stepper or bicycle as appropriate and transition to treadmill as walking improves. For participants randomly assigned to HIIT, the aim is to train for 30 minutes (plus 5 minutes warm up and cool down). These levels are typically not within the capabilities of persons within the first month post-stroke, so we will employ the recommendations for aerobic training during sub-acute rehabilitation by Ploughman et al. (2016). The first week will involve 10-minute blocks of training interspersed with 1-2-minutes of rest at low intensity (20-40% heart rate reserve [HRR]). Depending on the participants response (oxygen saturation, heart rate, blood pressure and perceived level of exertion), training time and speed will be increased and rests reduced to obtain HIIT (>60% HRR) targets. All training and patient response data will be recorded.
Intervention code [1] 325169 0
Rehabilitation
Comparator / control treatment
An allied health clinician (i.e., Physiotherapist or Exercise Physiologist) will implement 10 weeks of individually tailored MICT three times per week as per national and international guidelines. The program will be delivered in small groups of 2-4 participants in a rehabilitation gym using recumbent steppers, treadmills or bicycle ergometers depending on individual capability. Specifically, if the person is able to walk 10m with less than minimal physical assistance, they will begin training using a treadmill. Otherwise, they will use the stepper or bicycle as appropriate and transition to treadmill as walking improves. The aim is for participants to achieve 30 minutes of MICT (plus 5 minutes warm up and cool down). These levels are typically not within the capabilities of persons within the first month post-stroke, so we will employ the recommendations for aerobic training during sub-acute rehabilitation by Ploughman et al. (2016). The first week will involve 10-minute blocks of training interspersed with 1-2-minutes of rest at low intensity (20-40% HRR). Depending on the participants response (oxygen saturation, heart rate, blood pressure and perceived level of exertion), training time and speed will be increased and rests reduced to obtain MICT (40 to 60%HRR) targets. All training and patient response data will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 333491 0
Feasibility - Participant recruitment as assessed by the number and percentage of eligible participants recruited to participate. This will be captured by screening and recruitment logs.
Timepoint [1] 333491 0
Ongoing throughout study
Primary outcome [2] 333492 0
Feasibility - Participant retention rate and compliance to intervention. The number and percentage of participants retained at the end of the study will be used to determine participant retention rates. Compliance to the intervention will be measured by the number and percentage of exercise sessions attended during the study. Participants' flow through the study will be recorded. Intervention compliance will be recorded via log-book and activity charts by the attending allied health clinician.
Timepoint [2] 333492 0
Ongoing throughout study
Primary outcome [3] 333560 0
Safety - incidence of adverse events and serious adverse events. These will be captured via case report forms upon reporting of adverse or serious adverse event by participant or recorded by research assistant supervising delivery of intervention.
Timepoint [3] 333560 0
Ongoing throughout study
Secondary outcome [1] 417278 0
Walking speed: Participants will walk four times across a 10m walkway with or without a gait aid at both self-selected and fast (quickly, but safely) walking speed. Step counts are recorded and speed will be extracted. Participants who are unable to walk without physical assistance of another person will have walking speed imputed as half the mean of their respective group.
Timepoint [1] 417278 0
Post-completion of 10-week study period
Secondary outcome [2] 417279 0
Aerobic Fitness Test. Levels of cardiorespiratory fitness will be determined by the peak volume of oxygen consumption (VO2peak), maximal heart rate and workload achieved during a submaximal, graded exercise test using a total body recumbent stepper. The VO2peak dictates the exercise prescription and also serves as an outcome measure. We will use the total body recumbent stepper, rather than a treadmill or bicycle, since it is the most modifiable ergometer for people with disability. Participants will be screened (using the PAR-MED-X) in consultation with their rehabilitation physician to determine safety of performing a fitness test. Participants presenting with absolute contraindications to exercise will be excluded from participation. Heart rate (assessed by a heart rate monitor), and oxygen saturation (assessed by a pulse oximeter) will be monitored continuously during the exercise test, and before and after the test. Blood pressure (assessed using an automatic blood pressure monitor) will also be assessed before and after the test. We will use the Young Men’s Christian Association protocol. Participants will be instructed to maintain a step rate between 80-90 steps per minute (spm). Participants will begin the test at 30 watts, and resistance will be increased every three minutes according to the protocol until volitional fatigue, or 85% of age-predicted heart rate maximum is achieved. Participant’s heart rate will be recorded for ten seconds prior to the end of the second and third minute of each stage. If the two heart rate measures are within five beats-per-minute (bpm) of each other, participants will be progressed to the next stage. However, if the difference is greater than five bpm, an additional minute will be performed to ensure a steady-state is achieved. The workload in watts and heart rate at the end of the submaximal exercise test along with age, sex and weight (kg) will be used in an equation to predict VO2peak.
Timepoint [2] 417279 0
Post-completion of 10-week study period
Secondary outcome [3] 417280 0
Quality of Life. The EQ-5D has five questions pertaining to Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/Depression. The three response levels represent None, Some problems/Moderate, Unable/Extreme.
Timepoint [3] 417280 0
Post-completion of 10-week study period
Secondary outcome [4] 417437 0
Self=perceived health status: A 100 mm Visual Analogue Scale in which the person scores their current health from ‘best imaginable’ to ‘worst imaginable’.
Timepoint [4] 417437 0
Post-completion of 10-week study period
Secondary outcome [5] 417438 0
Acceptability of the intervention: Participants will be asked to complete a brief questionnaire (designed specifically for this study) to describe their experience in the trial (i.e., acceptability of the intervention, burden of the outcome assessments).
Timepoint [5] 417438 0
Post-completion of 10-week study period

Eligibility
Key inclusion criteria
Patients admitted to Epworth HealthCare Rehabilitation will be screened to determine their eligibility, namely they 1) have experienced an ischeamic or haemorrhagic stroke, 2) are less than one-month post-stroke, 3) are aged greater than or equal to 18 years, 4) are medically stable (as assessed by their treating Rehabilitation Physician), 5) are English speaking, 6) can provide informed consent to participate, and 7) are able to and agree to participate in either HIIT or MICT training in addition to their usual care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with stroke will be excluded from participating in the study if they 1) are pregnant women, or 2) present with absolute contraindications to exercise as determined by American College of Sports Medicine exercise prescription guidelines

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)
Allocation concealment by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created in excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome in this study is feasibility (Learmonth et al., 2018; Thabane et al., 2010). A sample size of 15 per group is similar to previous work by Ploughman et al. (2022) and is an achievable recruitment target at the pilot site. If we were to undertake a definitive trial with walking speed as the primary outcome, we expect to detect a 10cm/s between group difference in walking speed at post-intervention. With one-tailed, 1:1 allocation, 0.6 Effect size, Power 0.95, this would require 70 patients per group (G Power23). This project will not be powered for such an analysis but will provide critical pilot data to prepare for a future international, multi-centre RCT.

Because this is a pilot study, intervention outcomes will be evaluated using descriptive and non-parametric statistics and effect sizes. We will examine the relationships between stroke severity and improvement and evaluate treatment responses in females particularly. Descriptive statistics will be used to report feasibility and safety measures, and fidelity will be evaluated by ability of subjects to meet training targets.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
Date of last participant enrolment
Anticipated
20/11/2023
Actual
Date of last data collection
Anticipated
29/01/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23781 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment postcode(s) [1] 39228 0
3124 - Camberwell

Funding & Sponsors
Funding source category [1] 312928 0
Charities/Societies/Foundations
Name [1] 312928 0
Bethlehem Griffiths Research Foundation
Country [1] 312928 0
Australia
Primary sponsor type
Individual
Name
Dr Liam Johnson
Address
Epworth HealthCare
888 Toorak Rd
Camberwell
Victoria 3124
Country
Australia
Secondary sponsor category [1] 314614 0
None
Name [1] 314614 0
N/A
Address [1] 314614 0
N/A
Country [1] 314614 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312202 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312202 0
Ethics committee country [1] 312202 0
Australia
Date submitted for ethics approval [1] 312202 0
23/01/2023
Approval date [1] 312202 0
Ethics approval number [1] 312202 0

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

Contacts
Principal investigator
Name 123830 0
Dr Liam Johnson
Address 123830 0
Australian Catholic University
Locked Bag 4115
Fitzroy MDC, VIC 3165
Country 123830 0
Australia
Phone 123830 0
+61 0407981538
Fax 123830 0
Email 123830 0
[email protected]
Contact person for public queries
Name 123831 0
Liam Johnson
Address 123831 0
Australian Catholic University
Locked Bag 4115
Fitzroy MDC, VIC 3165
Country 123831 0
Australia
Phone 123831 0
+61 0407981538
Fax 123831 0
Email 123831 0
[email protected]
Contact person for scientific queries
Name 123832 0
Liam Johnson
Address 123832 0
Australian Catholic University
Locked Bag 4115
Fitzroy MDC, VIC 3165
Country 123832 0
Australia
Phone 123832 0
+61 0407981538
Fax 123832 0
Email 123832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator: Dr Liam Johnson ([email protected])


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
No additional documents have been identified.