Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000092796p
Ethics application status
Submitted, not yet approved
Date submitted
11/12/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
PeRsonalised Exercise for Priming Post-stroke (PREPP): A randomised trial
Scientific title
PeRsonalised Exercise for Priming Post-stroke (PREPP): A randomised trial
Secondary ID [1] 304789 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PREPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 324413 0
Condition category
Condition code
Stroke 321895 321895 0 0
Ischaemic
Stroke 321896 321896 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single study consisting of two phases. Recruited participants will sequentially complete both study phases. All exercise and upper limb training sessions will be conducted in the Exercise Lifestyle Clinic within the Australian Catholic University Strathfield campus.
Phase 1: Exercise training is recommended as part of a comprehensive and multidisciplinary stroke rehabilitation program to optimise recovery and reduce the risk of secondary stroke. All participants will undertake a six-week individualised exercise program, prescribed, and delivered by an accredited exercise physiologist, with one-hour exercise sessions completed on three weekdays per week. The exercises will be individualised to each participant based upon their baseline cardiorespiratory fitness (identified using a submaximal cycle ergometer test), their comorbidities and subsequent safety measures that must be taken. Subjective and objective measures taken at numerous timepoints throughout the six-weeks (e.g. Rate of Perceived Exertion, heart rate, assessment results) will be used to identify when the prescription should be amended and whether it needs to be regressed or progressed. The chosen exercises will be selected from aerobic and functional training recommendations for stroke survivors and individualised for each participant. Examples of aerobic exercise include cycling and treadmill walking. Examples of functional exercises include sit-to-stands, step ups and stair climbing. High-Intensity Interval Training (HIIT) style training (e.g. bouts of higher intensity exercise interspersed with lower-intensity exercise) will be progressively introduced during this program to prepare the participant for the HIIT program in Phase 2 of this study. The higher intensity intervals will begin with shorter durations and lower intensities, gradually increasing in duration and intensity as tolerated by the participant. In addition, the HIIT intervals may be spread across the one-hour session in the initial weeks of phase 1 and will be gradually added together in closer temporal proximity as the participant builds their fitness and tolerance. Exercise intensity will be monitored during throughout the exercise session using the Borg RPE scale. When the target RPE is not achieved, the exercise will be modified (made ‘easier’ or ‘harder) during the next session (e.g. increased/decreased resistance, increased/decreased revolutions per minute, more/less repetitions, etc) to ensure the participant reaches the target RPE for that exercise. This will be done to ensure the continued benefit of the program and to build the participant's tolerance for higher intensity exercise (e.g. 14-17/20 RPE).
Phase 2: Following the completion of the six-week individualised exercise program, participants will be randomised into one of two groups to undertake a two-week program of combined HIIT + modified-Constraint-Induced Movement therapy (mCIMT). The HIIT protocol will require participants to complete 4x4 minute intervals delivered on a bicycle ergometer (85% heart rate reserve [HRR]) interspersed with a three-minute active recovery (70% HRR), totalling 45 minutes of cycling. The mCIMT involves one-hour time on task of supervised task-oriented training augmented by progressively increasing home practice. The tasks provided will be individualised to the participant, based upon their motor function and requirements (e.g. shifting pegs, placing screws on a pipe, using cutlery, etc). Participants will be required to wear a mitt on the non-paretic limb for up to 90% of waking hours (to be removed for ambulation, toileting and other activities deemed unsafe) as part of the mCIMT transfer package. All HIIT and mCIMT sessions will be supervised by a trained accredited exercise physiologist. The transfer package is a set of behavioural interventions that aim to promote the transfer of clinic gains to daily function, including a behavioural contract and Motor Activity Log (MAL) to promote safety and monitor adherence to home practice, paretic limb use and mitt compliance during mCIMT, and to provide an opportunity for goal-setting and problem solving. Group 1 will undertake HIIT before the mCIMT session, and Group 2 will undertake HIIT after the mCIMT session. Both HIIT and mCIMT sessions will be prescribed and delivered by an accredited exercise physiologist trained in mCIMT, with the HIIT sessions completed on three weekdays per week and the mCIMT sessions completed on 10 consecutive weekdays.

An ActiGraph will be worn by the participant during Phase 1 and Phase 2 to monitor physical activity completed outside of the supervised sessions. The study team will download and recharge the ActiGraphs when the participant attends the clinic for their supervised sessions and will examine the data collected. The duration of moderate-to-high intensity exercise will be recorded and added to their weekly total.

Adherence of the sessions (Phase 1 and Phase 2) will be monitored using attendance checklists.
Intervention code [1] 322259 0
Rehabilitation
Comparator / control treatment
Phase 1: No comparator/control.
Phase 2: The results of the HIIT + mCIMT group, mCIMT + HIIT group and the mCIMT only group will be compared to each other. The mCIMT only group will be a historical
control group (McNulty et al., 2015). The data for this group was collected from 2011 to 2014.
Control group
Historical

Outcomes
Primary outcome [1] 329645 0
Serum Brain-Derived Neurotrophic Factor (BDNF) concentration
Timepoint [1] 329645 0
Week 3 after starting the intervention of Phase 1
Primary outcome [2] 329648 0
Serum Brain-Derived Neurotrophic Factor (BDNF) concentration
Timepoint [2] 329648 0
Week 6 after starting the intervention of Phase 1
Secondary outcome [1] 403279 0
Activity monitor data obtained from an Actigraph worn by the participant outside of supervised sessions. Training logs will also be used to identify the activity completed during supervised sessions.
Timepoint [1] 403279 0
Week 3, Week 6 and Week 8 after starting the intervention
Secondary outcome [2] 403280 0
Submaximal cycle ergometer test to assess cardiorespiratory fitness
Timepoint [2] 403280 0
Week 6 and Week 8 after starting the intervention
Secondary outcome [3] 403281 0
Blood lactate concentration
Timepoint [3] 403281 0
Week 3, Week 6, Week 8 after starting the intervention
Secondary outcome [4] 403283 0
Fugl-Meyer Assessment upper extremity subscale to assess upper limb ability
Timepoint [4] 403283 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [5] 403284 0
Wolf-Motor Function Test to assess upper-limb motor function
Timepoint [5] 403284 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [6] 403285 0
Box and Block Test to assess gross manual dexterity
Timepoint [6] 403285 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [7] 403286 0
Grooved Pegboard Test to assess fine manual dexterity
Timepoint [7] 403286 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [8] 403287 0
Motor Activity Log
Timepoint [8] 403287 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [9] 403288 0
Rating of Everyday Arm-use in the Community and Home
Timepoint [9] 403288 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [10] 403289 0
National Institutes of Health Stroke Scale
Timepoint [10] 403289 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [11] 403290 0
Modified Rankin Scale to assess post-stroke disability
Timepoint [11] 403290 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [12] 403291 0
10-Metre Walk Test to assess gait speed
Timepoint [12] 403291 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [13] 403292 0
6-Minute Walk Test to assess gait endurance
Timepoint [13] 403292 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [14] 403293 0
Depression, Anxiety, Stress Scale (DASS) is a composite questionnaire with specific questions examining depression, anxiety and stress, respectively
Timepoint [14] 403293 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [15] 403294 0
Fatigue Severity Scale answered by the participant to report how stroke has impacted their life
Timepoint [15] 403294 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [16] 403295 0
Stroke Impact Scale answered by the participant to report how stroke has impacted their life
Timepoint [16] 403295 0
Week 6, Week 8 and Week 12 after starting the intervention
Secondary outcome [17] 403296 0
Self-rated Satisfaction Scale answered by the participant to report their satisfaction with the intervention provided
Timepoint [17] 403296 0
Week 6 and Week 8 after starting the intervention
Secondary outcome [18] 403297 0
Self-rated Improvement Scale answered by the participant to report how they think their paretic limb function has improved following the interventions
Timepoint [18] 403297 0
Week 6 and Week 8 after starting the intervention

Eligibility
Key inclusion criteria
1. Diagnosis of ischaemic or haemorrhagic stroke.
2. Diagnosis of upper-limb hemiparesis with greater than or equal to 10 degrees of active movement in the paretic shoulder, elbow, wrist and greater than or equal to 2 digits.
3. Aged greater than or equal to 18 years.
4. Understand written and verbal commands provided in English.
5. Medical clearance from treating medical/allied health team at the referring hospital to participate in an individualised exercise program (including aerobic exercise [i.e. HIIT] and mCIMT).
6. Cognitively competent with a MMSE of greater than or equal to 24 out of 30. Potential participants be assessed by an independent assessor (e.g. medical/allied health team at referring hospital) to identify suitability for the study.
7. Meet the Covid-19 vaccination requirements of Australian Catholic University and be willing to adhere to all public health orders regarding testing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Undertaking any other formal exercise training program during the study period.
2. Women who are pregnant.
3. Diagnosis of a peripheral neuropathy causing significant sensorimotor impairment.
4. Diagnosis of any blood-borne infectious disease.
5. Diagnosis of condition(s) that may limit ability and safety of participation in HIIT (e.g. unstable cardiovascular disease, lower-limb conditions, etc.).

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 conducted by a member of the research team, off-site and not involved in the delivery of the exercise interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using an online random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Historical control group from a randomised controlled trial who completed the same mCIMT program and no HIIT (McNulty et al., 2015).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic data will be tested for normality and presented as mean and standard error, medians and interquartile range and percentages where appropriate. Repeated measures ANOVA with an effect of time and pairwise comparisons will be used to establish the effect of exercise training on BDNF concentrations and cortical size activated during upper-limb movement. One-way repeated measures ANOVAs will be used for functional assessment data. Significance will be taken at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21184 0
Metropolitan Rehabilitation Hospital - Petersham
Recruitment hospital [2] 21185 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 36048 0
2049 - Petersham
Recruitment postcode(s) [2] 36049 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 309163 0
University
Name [1] 309163 0
Australian Catholic University
Country [1] 309163 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
163-167 Albert Road
Strathfield, NSW, 2135
Country
Australia
Secondary sponsor category [1] 310119 0
None
Name [1] 310119 0
Address [1] 310119 0
Country [1] 310119 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309025 0
Royal Prince Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 309025 0
Ethics committee country [1] 309025 0
Australia
Date submitted for ethics approval [1] 309025 0
22/11/2021
Approval date [1] 309025 0
Ethics approval number [1] 309025 0
Ethics committee name [2] 309898 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 309898 0
Ethics committee country [2] 309898 0
Australia
Date submitted for ethics approval [2] 309898 0
30/12/2021
Approval date [2] 309898 0
Ethics approval number [2] 309898 0
Ethics committee name [3] 309899 0
Royal Rehab Research Governance Office
Ethics committee address [3] 309899 0
Ethics committee country [3] 309899 0
Australia
Date submitted for ethics approval [3] 309899 0
30/12/2021
Approval date [3] 309899 0
Ethics approval number [3] 309899 0

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

Contacts
Principal investigator
Name 112690 0
Dr Angelica Thompson-Butel
Address 112690 0
Australian Catholic University, School of Behavioural and Health Sciences
Level 1, 163-167 Albert Road
Strathfield, NSW, 2135
Country 112690 0
Australia
Phone 112690 0
+61 2 9701 4739
Fax 112690 0
Email 112690 0
[email protected]
Contact person for public queries
Name 112691 0
Angelica Thompson-Butel
Address 112691 0
Australian Catholic University, School of Behavioural and Health Sciences
Level 1, 163-167 Albert Road
Strathfield, NSW, 2135
Country 112691 0
Australia
Phone 112691 0
+61 2 9701 4739
Fax 112691 0
Email 112691 0
[email protected]
Contact person for scientific queries
Name 112692 0
Angelica Thompson-Butel
Address 112692 0
Australian Catholic University, School of Behavioural and Health Sciences
Level 1, 163-167 Albert Road
Strathfield, NSW, 2135
Country 112692 0
Australia
Phone 112692 0
+61 2 9701 4739
Fax 112692 0
Email 112692 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?
De-identified Brain-Derived Neurotrophic Factor (BDNF) concentrations will be available through contact with the Primary Investigator via telephone or email. De-identified BDNF genotype may also be distributed via communication with the Primary Investigator.
When will data be available (start and end dates)?
Data will be available from 01 March 2024, with no current specified end date.
Available to whom?
Data will be available to individuals on a case-by-case basis at the discretion of Primary Investigator.
Available for what types of analyses?
Data will be available for any purpose as outlined in the communication with the Primary Investigator.
How or where can data be obtained?
Data can be obtained subject to approvals by Principal Investigator who can be contacted via email or telephone ([email protected] or +61 2 9701 4739).


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.