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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04657029




Registration number
NCT04657029
Ethics application status
Date submitted
22/11/2020
Date registered
8/12/2020

Titles & IDs
Public title
Aerobic Exercise and Sensorimotor Adaptation in Chronic Stroke
Scientific title
The Acute Effects of Aerobic Exercise on Sensorimotor Adaptation in Chronic Stroke
Secondary ID [1] 0 0
ChrisMackaySensMotStroke2020
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Treadmill

Experimental: Treadmill condition - The intervention condition consisted of a single session of moderate-high intensity aerobic exercise (65% of heart rate reserve) for 30 minutes walking on a standard treadmill. The single treadmill session included a progressive increase in intensity to reach the target heart rate (approx. 5 mins) as well as a cooling down period (approx. 5 mins). The warm-up and cool-down were included as part of the total 30 minutes of walking exercise. Target heart rates were calculated using the Karvonen method \[25\] with levels adjusted for those taking heart rate lowering medications (i.e. beta blockers), following methods previously published in post stroke populations \[26, 27\]. Participants were asked to self-rate their intensity of exercise every 10 minutes verbally using BORG's 6-20 scale rating of perceived exertion \[28\]. Participants were instructed to walk at a pace that resulted in a rating between 11 (fairly light) and 14 (somewhat hard) on the scale.

Other: Control condition - The control condition involved an equivalent time period (30 minutes) of seated resting where participants were provided with an education session about the impact and effects of stroke by the same research assistant.


BEHAVIORAL: Treadmill
30 minutes of moderate-high intensity treadmill training.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensorimotor adaptation change
Timepoint [1] 0 0
Pre and Post intervention and Pre and Post Control. There was one week between the two conditions

Eligibility
Key inclusion criteria
* Clinical diagnosis of stroke
* Time of stroke greater than three months ago
* Be able to walk with or without and aid for at least 10 metres
* Understand three stage commands
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to walk independently prior to current stroke
* Have co-morbidities that limit their walking (e.g. arthritis, orthopaedic surgery)
* Unstable cardiac status
* Unable to understand three stage commands
* Unable to provide informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2020
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04657029