Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000912684
Ethics application status
Approved
Date submitted
15/08/2014
Date registered
26/08/2014
Date last updated
26/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Establishing a dose of exercise tolerated by stroke survivors with walking impairment: A phase 1 dose-escalation trial
Scientific title
Maximum dose of exercise tolerated by stroke survivors with walking impairment, after a 12 week multimodal exercise program.
Secondary ID [1] 285179 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 292775 0
Walking impairment 292777 0
Condition category
Condition code
Stroke 293070 293070 0 0
Ischaemic
Stroke 293071 293071 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 293108 293108 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention was a 12 week multimodal exercise program, three sessions each week. Sessions were individual run by a rehabilitation physiotherapist at the participating hospital. The first 4 weeks were 360 min per week, next 4 weeks 420 min per week, last 4 weeks (dose Maximization) was guided by cumulative 3+3 dose escalation design aiming to go up to 750 min per week. A description and examples of the types of exercises are;

Endurance training was delivered using a combination of cycling, treadmill and over-ground walking. Endurance training time was planned to progress by 5-15% every week. We aimed for a moderate level of training intensity, with the Borg Rate of Perceived Exertion (RPE) =11. Most endurance activities used steady state training, with interval training added for variety and when RPE levels dropped below 11. Planned interval training included a variety of regimes with a set time at a higher effort (on) followed by low effort recovery (off), e.g., 4 minutes on:2 minutes off, 3 minutes on:3 minutes off.

Progressive Resistance Training (PRT) followed a standardized format. Five lower limb strengthening exercises, with free weights or pin-loaded machine weights, were tailored to each participant. Exercises included single or double leg press, calf press, hip abduction, hip extension, hamstring curls and quadriceps over fulcrum. Variation in the weight, number of sets, repetitions and speed of contractions were modified to vary the training stimulus. Amount of weight was increased if the target repetition maximum was achieved. During the Dose-maximization phase participants performed HVPRT, which involves rapid concentric, followed by slower eccentric, muscle contractions.
Task-related practice was integral to the program, with emphasis on activities that challenged balance and community walking ability. Stepping and walking progressions included obstacle clearance of the lead and trail legs, variable surfaces, gradients, speed and direction changes, external perturbations, changing environmental demands and dual tasks.
Intervention code [1] 290035 0
Rehabilitation
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292936 0
The amount of exercise (as measured in total number of minutes) participants were able to complete per week during the Dose-maximization phase without reaching the dose limiting criteria (DLT). DLT thresholds were: (1) failure to complete more than 20% of prescribed weekly exercise dose due to pain, fatigue or effort required (e.g., if the weekly dose was 540 minutes, >432 minutes must be completed), and (2) the after effects of exercise resulted in the participant being unable to perform usual activities of daily living. This was established by a single question each training day.
Timepoint [1] 292936 0
End of 12 week intervention period
Secondary outcome [1] 309978 0
Six minute walk test
Timepoint [1] 309978 0
End of 12 week intervention period
Secondary outcome [2] 310062 0
four square step test
Timepoint [2] 310062 0
End of 12 week intervention period
Secondary outcome [3] 310063 0
Timed up and go test
Timepoint [3] 310063 0
End of the 12 week intervention period

Eligibility
Key inclusion criteria
Aged at least 18 years with impaired balance, limited community walking and considered ‘at risk’ of falls. They must at discharge from our hospital also meet the following criteria: (1) walking less than 250 metres for the Six Minute Walk Test, (2) taking at least 15 seconds (or unable) to complete the Four Square Step Test, (3) cognitively able to follow an exercise program (equal to a score of 4 on the FIM19 problem solving, memory and comprehension items), (4) living at home, and (5) between 1 to 5 years post-stroke.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To be eligible, written medical clearance to participate in an exercise program was required.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
30/09/2013
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289789 0
Charities/Societies/Foundations
Name [1] 289789 0
National Stroke Foundation
Country [1] 289789 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Florey Institute of Neuroscience and Mental Health
Address
245 Burgundy st Heidelberg, VIC 3089
Country
Australia
Secondary sponsor category [1] 288481 0
None
Name [1] 288481 0
Nil
Address [1] 288481 0
Nil
Country [1] 288481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291526 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 291526 0
Austin Health
145 Studley Road
Heidelberg
Victoria
Australia, 3084
Ethics committee country [1] 291526 0
Australia
Date submitted for ethics approval [1] 291526 0
Approval date [1] 291526 0
22/04/2013
Ethics approval number [1] 291526 0
H2013/04973

Summary
Brief summary
Stroke survivors with poor balance and walking impairments have low activity levels and are at risk of falls. Targeted exercise can improve mobility.
However, the absence of dose-finding studies may explain the limited effects of exercise delivered in many trials. In this dose-escalation study, we tested the feasibility of using dose-escalation methods, common in Phase 1 pharmaceutical trials, to determine the maximum tolerable dose of exercise in chronic stroke survivors with substantial mobility impairment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50738 0
A/Prof Julie Bernhardt
Address 50738 0
Florey Institute of Neuroscience and Mental Health
Melbourne Brain Center
245 Burgundy st Heidelberg
Victoria, 3089
Country 50738 0
Australia
Phone 50738 0
+61 3 9035 7072
Fax 50738 0
Email 50738 0
[email protected]
Contact person for public queries
Name 50739 0
Wayne Dite
Address 50739 0
Royal Talbot Rehabilitation Centre
1 Yarra Boulevard
Kew
Victoria
Australia 3101
Country 50739 0
Australia
Phone 50739 0
+61 3 9490 7500
Fax 50739 0
Email 50739 0
[email protected]
Contact person for scientific queries
Name 50740 0
Julie Bernhardt
Address 50740 0
Florey Institute of Neuroscience and Mental Health
Melbourne Brain Centre
245 Burgundy st Heidelberg, VIC, 3089
Country 50740 0
Australia
Phone 50740 0
+61 3 9035 7072
Fax 50740 0
Email 50740 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
EmbaseA Phase 1 exercise dose escalation study for stroke survivors with impaired walking.2015https://dx.doi.org/10.1111/ijs.12548
N.B. These documents automatically identified may not have been verified by the study sponsor.