Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001083088
Ethics application status
Approved
Date submitted
1/12/2010
Date registered
8/12/2010
Date last updated
9/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise- can it help the brain change itself?
Scientific title
Does acute exercise promote neuroplasticity in the motor cortex of healthy individuals and those following stroke?
Secondary ID [1] 253221 0
UniSA Human Research Ethics committee protocol number 021143
Universal Trial Number (UTN)
Trial acronym
PLEX study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 258757 0
Condition category
Condition code
Stroke 258904 258904 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aerobic exercise on a stationary bicycle. Healthy participants will cycle at 75% of their maximal heart rate for 15 minutes in the moderate intensity exercise session and in the low intensity condition they will cycle at half this workload for 30 minutes. The results from Stage 1 will determine the exercise intensity the stroke participants will exercise at, and for how long. Each exercise session will be supervised by a physiotherapist, trained in CPR, and will be conducted at least 1 week apart. Healthy participants are involved in three sessions (control, low or moderate intensity exercise) and stroke participants in two sessions (exercise or control). The order of testing sessions in this cross-over study will be randomised within groups. The second phase of the study with people following stroke will be conducted over three sessions: a control, low intensity session at a somewhat light intensity and repetitive brain stimulation, and a low intensity session without the plasticity inducing paradigm but other tests to probe changes in cortical excitability. Participants will cycle on an exercise bike at approximately 55% age-predicted max HR for 30 mins. Each session is separated by at least one week.
The brain stimulation (TMS or Transcranial Magnetic Stimulation) procedure involves sitting in a comfortable armchair with adhesive electrodes attached to the skin over the affected hand. The magnetic field stimulates the cortical cells, causing the hand muscles to fire and this EMG activity is recorded. TMS is performed before and after the exercise, and involves single pulse, paired pulse and repetitive TMS to probe cortical excitability, intracortical inhibition, and stimulation induced plasticity respectively and takes approximately 10 mins to complete single pulse TMS at 120% of resting threshold, and intracortical inhibition according to established protocols.
Intervention code [1] 257693 0
Rehabilitation
Comparator / control treatment
A control condition involves seated relaxation for 30 minutes. In this time, participants may rest quietly in an armchair or read a book and this condition occurs once for each group (healthy or stroke participants).
Control group
Active

Outcomes
Primary outcome [1] 259760 0
Neuroplasticity as assessed using transcanial magnetic stimulation; participants will have their baseline cortical excitability assessed prior to exercise, then after exercise plasticity will be assessed using theta burst stimulation after both the control and exercise conditions.
Timepoint [1] 259760 0
Baseline and after exercise and at 30 minutes post exercise
Secondary outcome [1] 268522 0
Blood serum levels of cortisol and brain derived neurotrophic factor
Timepoint [1] 268522 0
Baseline, post exercise and at 10 and 15 minutes following exercise
Secondary outcome [2] 339612 0
Intracortical inhibition meausured using paired pulse TMS at 2 and 3 ms intervals
Timepoint [2] 339612 0
Before and up to 30 minutes following exercise

Eligibility
Key inclusion criteria
Healthy. moderately active right-handed adults for phase I of the trial
Stroke patients, at least 6 months post stroke for phase II
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Epilepsy
Medication to thin the blood or other medication that may alter cortical excitability or response to brain stimulation e.g. antidepressants
Cardiac pacemaker

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)
For Stage 1 - Healthy participants will take part in three sessions a week apart, comparing the effect of exercise on the brain. The three conditions are sedentary control, cycle on an exercise bike at 75% of their maximal heart rate for 15 minutes in the moderate intensity exercise session and in the low intensity condition they will cycle at half this workload for 30 minutes. In Stage 2 - Participants with stroke will take part in three sessions a week apart, comparing the effect of exercise on the brain. The three conditions are sedentary control, cycle on an exercise bike at low intensity for 30 minutes at a somewhat light intensity and repetitive brain stimulation, and a low intensity session without the plasticity inducing paradigm but other tests to probe changes in cortical excitability. Allocation to each condition was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of the conditions (control or exercise first) will be randomised using a random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The experiments will be in two phases. First, healthy controls will undergo the experiments to investigate the effect of low or moderate intensity exercise on neuroplasticity. In phase II, stroke patients will be recruited in a cross-over design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2010
Actual
10/12/2010
Date of last participant enrolment
Anticipated
Actual
30/05/2015
Date of last data collection
Anticipated
Actual
30/06/2015
Sample size
Target
22
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258166 0
Charities/Societies/Foundations
Name [1] 258166 0
Brain Foundation
Country [1] 258166 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 257340 0
None
Name [1] 257340 0
Address [1] 257340 0
Country [1] 257340 0
Other collaborator category [1] 251709 0
Individual
Name [1] 251709 0
Dr Michael Ridding
Address [1] 251709 0
University of Adelaide
Robinson Institute
Adelaide SA 5005
Country [1] 251709 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260151 0
University of South Australia
Ethics committee address [1] 260151 0
Ethics committee country [1] 260151 0
Australia
Date submitted for ethics approval [1] 260151 0
Approval date [1] 260151 0
29/09/2010
Ethics approval number [1] 260151 0
021143
Ethics committee name [2] 260152 0
The University of Adelaide
Ethics committee address [2] 260152 0
Ethics committee country [2] 260152 0
Australia
Date submitted for ethics approval [2] 260152 0
Approval date [2] 260152 0
23/08/2010
Ethics approval number [2] 260152 0
H-123-2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2101 2101 0 0
/AnzctrAttachments/336302-Priming the brain.docx
Attachments [2] 2102 2102 0 0
/AnzctrAttachments/336302-McDonnell_etal_2013_JAP final.pdf

Contacts
Principal investigator
Name 31980 0
Dr Michelle McDonnell
Address 31980 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5000
Country 31980 0
Australia
Phone 31980 0
+61 88302 1684
Fax 31980 0
Email 31980 0
[email protected]
Contact person for public queries
Name 15227 0
Dr Michelle McDonnell
Address 15227 0
Sansom Institute for Health Research
The University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 15227 0
Australia
Phone 15227 0
+61 8 8302 1684
Fax 15227 0
Email 15227 0
[email protected]
Contact person for scientific queries
Name 6155 0
Dr Michelle McDonnell
Address 6155 0
Sansom Institute for Health Research
The University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 6155 0
Australia
Phone 6155 0
+61 8 8302 1684
Fax 6155 0
Email 6155 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
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