Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000848404
Ethics application status
Approved
Date submitted
6/06/2016
Date registered
29/06/2016
Date last updated
7/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aerobic exercise to increase efficacy of task-specific training for the upper limb after stroke: a pilot study
Scientific title
Aerobic exercise to increase efficacy of task-specific training for the upper limb after stroke: a pilot study
Secondary ID [1] 289136 0
None
Universal Trial Number (UTN)
Trial acronym
AExaCTT (Aerobic Exercise and Combined Task-specifc Training)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298647 0
Condition category
Condition code
Stroke 298711 298711 0 0
Ischaemic
Stroke 298712 298712 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 299250 299250 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aerobic Exercise and Consecutive Task-specific Training

The intervention will be delivered 3 days per week for 10 weeks.

Aerobic Exercise (30 minutes)
The aerobic exercise is performed on an upright or semi-recumbent cycle ergometer (depending on individual ability and impairment). Participants will perform 4×4-minute intervals of high-intensity exercise (85% of HRpeak) with a 3-minute active recovery (70% of HRpeak) period between each interval per 30 minute session. In the last 15 seconds of each interval heart rate (via a polar heart rate monitor) and rating of perceived exertion (RPE) will be recorded in the exercise logs by research assistants, along with watts, cadence and actual duration of exercise achieved. The aerobic exercise will be supervised by a physiotherapist.

Task-specific Training (60 minutes, performed immediately after aerobic exercise)
The task-specific training comprises of breaking down everyday skills into functional components that maintain a strong resemblance to the original skill itself. Task prescription will consider individual goals and appropriate exercises are then selected from an upper limb rehabilitation manual containing 142 predefined activities and movements (Cunningham et al. 2015). The difficulty of each component exercise is graded, reviewed and progressed according to the individual ability of the participant, with the aim of completing between 100-300 repetitions per session. If necessary, participants initially train on component movements of a skill until each component is mastered, and then combined into their original sequence to perform the whole skill, or as much of the whole skill as possible. Participants are encouraged to use different objects that vary in terms of shape, size and texture to ensure variability of training. Task-specific training will be supervised by a physiotherapist or occupational therapist. Participants will also be provided with an individually-prescribed task-specific training programme to practice at home for 60 minutes, 3 times per week.

Any variations to intervention protocol will be recorded in the participant training diaries by the researcher supervising the session and adherence to the home-based practice will be self-reported once a week. Compliance will be determined as the number of training sessions attended and time spent actively training relative to the total prescribed. Rate of retention will be measured as the per cent of participants who complete the intervention relative to the number randomised.

Cunningham, P., Turton, A., Van Wijck, F. and Van Vliet, P., 2015. Task-specific reach-to-grasp training after stroke: Development and description of a home-based intervention. Clinical rehabilitation, p.0269215515603438.
Intervention code [1] 294657 0
Rehabilitation
Comparator / control treatment
Task-specific Training only

The intervention will be delivered 3 days per week for 10 weeks.

Task-specific Training (60 minutes)
The task-specific training comprises of breaking down everyday skills into functional components that maintain a strong resemblance to the original skill itself. Task prescription will consider individual goals and appropriate exercises are then selected from an upper limb rehabilitation manual containing 142 predefined activities and movements (Cunningham et al. 2015). The difficulty of each component exercise is graded, reviewed and progressed according to the individual ability of the participant, with the aim of completing between 100-300 repetitions per session. If necessary, participants initially train on component movements of a skill until each component is mastered, and then combined into their original sequence to perform the whole skill, or as much of the whole skill as possible. Participants are encouraged to use different objects that vary in terms of shape, size and texture to ensure variability of training. Task-specific training will be supervised by a physiotherapist or occupational therapist. Participants will also be provided with an individually-prescribed task-specific training programme to practice at home for 60 minutes, 3 times per week.

Any variations to intervention protocol will be recorded in the participant training diaries by the researcher supervising the session and adherence to the home-based practice will be self-reported once a week. Compliance will be determined as the number of training sessions attended and time spent actively training relative to the total prescribed. Rate of retention will be measured as the per cent of participants who complete the intervention relative to the number randomised.

Cunningham, P., Turton, A., Van Wijck, F. and Van Vliet, P., 2015. Task-specific reach-to-grasp training after stroke: Development and description of a home-based intervention. Clinical rehabilitation, p.0269215515603438.
Control group
Active

Outcomes
Primary outcome [1] 298191 0
Upper Limb Function - Wolf Motor Function Test
Timepoint [1] 298191 0
<1 week of completing intervention
Primary outcome [2] 298735 0
Upper Limb Motor Function - Action Research Arm Test
Timepoint [2] 298735 0
<1 week of completing intervention
Secondary outcome [1] 323447 0
Participation - Stroke Impact Scale
Timepoint [1] 323447 0
<1 week of completing intervention
Secondary outcome [2] 325096 0
Self-reported Upper Limb use - Motor Activity Log
Timepoint [2] 325096 0
<1 week of completing intervention
Secondary outcome [3] 325097 0
Peripheral serum BDNF blood concentration
Timepoint [3] 325097 0
<1 week of completing intervention
Secondary outcome [4] 325098 0
Kinematics - Qualysis Motion Analysis
Timepoint [4] 325098 0
<1 week of completing intervention
Secondary outcome [5] 325099 0
Brain Activity - Functional MRI
Timepoint [5] 325099 0
<1 week of completing intervention
Secondary outcome [6] 325100 0
Functional Fitness - 6 Minute Walk Test
Timepoint [6] 325100 0
<1 week of completing intervention
Secondary outcome [7] 325101 0
Aerobic Fitness - Submaximal VO2 Cycle Ergometer Test
Timepoint [7] 325101 0
<1 week of completing intervention
Secondary outcome [8] 325102 0
Fatigue - Fatigue Assessment Scale
Timepoint [8] 325102 0
<1 week of completing intervention
Secondary outcome [9] 325103 0
Physical Activity - International Physical Activity Questionnaire
Timepoint [9] 325103 0
<1 week of completing intervention
Secondary outcome [10] 325104 0
BMI - Automatic BMI Stadiometer
Timepoint [10] 325104 0
<1 week of completing intervention
Secondary outcome [11] 325113 0
Waist-Hip Ratio - Circumference Tape Measurements of Waist and Hips
Timepoint [11] 325113 0
<1 week of completing intervention
Secondary outcome [12] 325114 0
Rate of recruitment - The percentage of potentially eligible participants who provide consent to participate relative to the total number of potentially eligible participants.
Timepoint [12] 325114 0
End of trial
Secondary outcome [13] 325115 0
Compliance - the number of training sessions attended and time spent actively training relative to the total prescribed.

Any variations to intervention protocol will be recorded in the participant training diaries by the researcher supervising the session and adherence to the home-based practice will be self-reported once a week.
Timepoint [13] 325115 0
End of trial
Secondary outcome [14] 325116 0
Acceptability of the aerobic exercise and consecutive task-specific training intervention - Dichotomous questionnaire. (designed specifically for this study)
Timepoint [14] 325116 0
<1 week of completing intervention
Secondary outcome [15] 325117 0
Exertional fatigue during the treatment session - Visual Analogue Scale
Timepoint [15] 325117 0
First session of each week until completion of intervention
Secondary outcome [16] 325118 0
Rate of retention - the per cent of participants who complete the intervention relative to the number randomised.
Timepoint [16] 325118 0
End of trial
Secondary outcome [17] 325119 0
Completeness of outcome data - the percentage of missing data relative to that expected.
Timepoint [17] 325119 0
End of trial
Secondary outcome [18] 325120 0
Adverse events - Will be recorded as adverse events (ADs) and serious adverse events (SAD) and reported to the Hunter New England Human Research Ethics Committee and the University of Newcastle Human Research Ethics Committee and Health and Safety Committee.

Adverse Events (AE) will be defined as any untoward or unfavourable medical occurrence including any abnormal sign, symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research. An example of a possible serious adverse event would be a fall.

Serious Adverse Event (SAE) will be defined as any adverse event that 1) results in death, 2) is life threatening, or places the participant at immediate risk of death from the event as it occurred, 3) requires or prolongs hospitalisation, 4) causes persistent or significant disability or incapacity, 5) results in congenital anomalies or birth defects, or 6) is another condition which investigators judge to represent significant hazards. An example of a possible serious adverse event would be a Cardiac Event.
Timepoint [18] 325120 0
Recorded immediately.
Measured for entire duration of trial i.e. between baseline measures and final follow-up measures.
Secondary outcome [19] 325121 0
Amendments to eligibility criteria and screening procedures - documented by the trial coordinator.
Timepoint [19] 325121 0
Recorded immediately.
Measured throughout the duration of the trial.
Secondary outcome [20] 325122 0
Any unblinding events - recorded by the lead outcome assessor and reported to the trial coordinator for investigation.
Timepoint [20] 325122 0
Recorded immediately.
Measured throughout the duration of the trial.

Eligibility
Key inclusion criteria
Clinical diagnosis of ischaemic or haemorrhagic stroke
Remaining upper limb movement deficit (i.e., score <63 on WMFT)
Able to partake in the aerobic exercise training
GP medical clearance
Willing to participate in the project
Have the capacity to provide informed written consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Upper limb movement deficits attributable to non-stroke pathology
Cannot lift their hand off their lap when asked to place their hand behind their head (gross motor task from the ARAT)
Have severe fixed contractures of elbow or wrist (i.e. grade 4 on the modified Ashworth scale)
Have moderate to severe receptive aphasia (<10 on ‘receptive skills’ of Sheffield Screening Test for Acquired Language Disorders)

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)
The pre-generated randomisation schedule will be uploaded to a thereafter inaccessible section of the REDCap database.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A concealed computerised randomisation schedule using block randomisation stratified according to ARAT score will be pre-generated by Sealed Envelope Ltd.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size estimation was based on detecting the MCID (minimum clinically important difference) in the ARAT and was performed using G*Power and resulted in a group size of 20 participants per group, to detect a difference of 0.85 standard deviations at the significance level of 0.05 and power of 0.8. To account for possible loss to follow-up, an additional 20% will be recruited, resulting in a group size of 24 and a total number of participants of 48.

As this is primarily a feasibility study to test the levels of recruitment and retention of participants, and completeness of data that can be expected within a definitive multi-centre trial, there will be no formal statistical testing, and results will instead be summarised using descriptive statistics.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
10/03/2016
Date of last participant enrolment
Anticipated
10/03/2017
Actual
30/05/2017
Date of last data collection
Anticipated
16/02/2018
Actual
30/01/2018
Sample size
Target
48
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293513 0
Charities/Societies/Foundations
Name [1] 293513 0
National Stroke Foundation
Country [1] 293513 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 292339 0
Individual
Name [1] 292339 0
Jennie Thomas
Address [1] 292339 0
c/o Hunter Medical Research Institute
1 Kookaburra Circuit
New Lambton Heights
NSW 2305
Country [1] 292339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294957 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 294957 0
Ethics committee country [1] 294957 0
Australia
Date submitted for ethics approval [1] 294957 0
02/12/2014
Approval date [1] 294957 0
04/03/2015
Ethics approval number [1] 294957 0
14/12/10/4.07

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

Contacts
Principal investigator
Name 65606 0
Prof Robin Callister
Address 65606 0
Priority Research Centre for Physical Activity and Nutrition
ATC Building Room 301
Callaghan Campus
The University of Newcastle
University Drive
Callaghan
NSW 2308
Country 65606 0
Australia
Phone 65606 0
+61 (0)2 49215650
Fax 65606 0
Email 65606 0
[email protected]
Contact person for public queries
Name 65607 0
Sarah Valkenborghs
Address 65607 0
Priority Research Centre for Physical Activity and Nutrition
ATC Building Room 301
Callaghan Campus
The University of Newcastle
University Drive
Callaghan
NSW 2308
Country 65607 0
Australia
Phone 65607 0
+61 2 40420819
Fax 65607 0
Email 65607 0
[email protected]
Contact person for scientific queries
Name 65608 0
Sarah Valkenborghs
Address 65608 0
Priority Research Centre for Physical Activity and Nutrition
ATC Building Room 301
Callaghan Campus
The University of Newcastle
University Drive
Callaghan
NSW 2308
Country 65608 0
Australia
Phone 65608 0
+61 2 40420819
Fax 65608 0
Email 65608 0
[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
SourceTitleYear of PublicationDOI
EmbaseAExaCTT - Aerobic Exercise and Consecutive Task-specific Training for the upper limb after stroke: Protocol for a randomised controlled pilot study.2017https://dx.doi.org/10.1016/j.conctc.2017.07.009
N.B. These documents automatically identified may not have been verified by the study sponsor.