Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001241527
Ethics application status
Approved
Date submitted
10/11/2015
Date registered
12/11/2015
Date last updated
29/01/2020
Date data sharing statement initially provided
29/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Strength training and non-invasive brain stimulation to improve walking and balance in Parkinson's disease
Scientific title
Effects of a 6 week lower body strength training intervention with concurrent transcranial direct current stimulation (tDCS) on gait, balance, strength and neurophysiological measures in Parkinson's disease.
Secondary ID [1] 287829 0
None
Universal Trial Number (UTN)
U1111-1176-3217
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 296718 0
Condition category
Condition code
Neurological 296951 296951 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strength training with tDCS (group 1): 6 week strength training program for the lower body including leg press, sit-to-stands, calf raises, toe lifts, and balance tasks. 3 sets of 6-8 repetitions will be performed at 70% of single repetition maximum for each exercise. 3 x 1 hour sessions are performed each week (total 18 sessions), with the intensity of each exercise progressing by 5% as the participant becomes stronger. tDCS is applied to the motor area of the brain during the first 20 mins of exercise, at an intensity of 2mA. This will involve wearing dampened electrode sponges secured on the scalp with rubber straps, and usually results in a light tingling or warm sensation. All session are performed one-on-one with an exercise physiologist or researcher, in the Deakin University clinical exercise space. Attendance and performance in each exercise will be recorded, with a minimum 80% attendance rate required.

Strength training with sham tDCS (group 2): 6 week strength training program for the lower body including leg press, sit-to-stands, calf raises, toe lifts, and balance tasks. 3 sets of 6-8 repetitions will be performed at 70% of single repetition maximum for each exercise. 3 x 1 hour sessions are performed each week (total 18 sessions), with the intensity of each exercise progressing by 5% as the participant becomes stronger. Sham tDCS is applied to the motor area of the brain, with stimulation ceasing after 15 seconds. This will involve wearing dampened electrode sponges secured on the scalp with rubber straps, and usually results in a light tingling or warm sensation. All session are performed one-on-one with an exercise physiologist or researcher, in the Deakin University clinical exercise space. Attendance and performance in each exercise will be recorded, with a minimum 80% attendance rate required.
Intervention code [1] 293219 0
Treatment: Devices
Intervention code [2] 293220 0
Treatment: Other
Comparator / control treatment
Control (group 3): Patients receive standard care for 6 weeks. This typically involves continuation of prescribed pharmaceutical treatment, and maintaining scheduled visits with neurologist and GP.
Control group
Active

Outcomes
Primary outcome [1] 296561 0
Balance, assessed with postural sway on portable force plate
Timepoint [1] 296561 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Primary outcome [2] 296562 0
Gait speed, assessed with zeno gait analysis walkway
Timepoint [2] 296562 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Primary outcome [3] 296563 0
Corticopsinal excitability of the Tibialis Anterior muscle assessed with transcranial magnetic stimulaiton
Timepoint [3] 296563 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [1] 318754 0
Functional strength of the lower limb, assessed with single repetition maximum strength tests.
Timepoint [1] 318754 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [2] 318755 0
Score on the Unified Parkinson's Disease Rating Scale (UPDRS) part 3 motor examination
Timepoint [2] 318755 0
baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [3] 318756 0
blood oxygenation of the dorsolateral prefrontal cortex during gait, cognitive task and combined gait and cognitive task, assessed with functional near-infrared spectroscopy.
Timepoint [3] 318756 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [4] 318813 0
Stride length, assessed with zeno gait analysis walkway
Timepoint [4] 318813 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [5] 318814 0
Stride variability, assessed with zeno gait analysis walkway
Timepoint [5] 318814 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [6] 318815 0
Gait speed while performing cognitive task (counting backwards by 7), assessed with zeno gait analysis walkway
Timepoint [6] 318815 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [7] 318816 0
Stride length while performing cognitive task (counting backwards by 7), assessed with zeno gait analysis walkway
Timepoint [7] 318816 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [8] 318817 0
Stride variability while performing cognitive task (counting backwards by 7), assessed with zeno gait analysis walkway
Timepoint [8] 318817 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [9] 318818 0
Intracortical inhibition of the Tibialis Anterior muscle, assessed with paired-pulse trancranial magnetic stimulation
Timepoint [9] 318818 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention
Secondary outcome [10] 318820 0
Silent period of the motor potential evoked from the Tibialis Anterior muscle, assessed with transcranial magnetic stimulation
Timepoint [10] 318820 0
Baseline, 3 weeks, 6 weeks and 9 weeks following the commencement of the intervention

Eligibility
Key inclusion criteria
1) Diagnosed with Parkinson's disease by an independent neurologist.
2) Moderate to severe motor symptoms (score of 2.5 or greater on the Hoehn and Yahr scale).
3) Stable drug regime.
4) History of 1 or more falls in the last 24 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Presence of other neurological or brain related conditions, such as Alzheimer's disease, stroke, or epilepsy.
2) Cardiac pacemaker, deep brain stimulator, or other implanted medical device
3) Currently undertaking physical therapy or structured exercise program for the lower body.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies, 10 participants in each group (n = 30, total) will provide at least 80% power to detect a 15% difference in primary outcome measures assuming a standard deviation of 10-15% between groups. a two way repeated measures analysis of variance with factors TIME (baseline, 3 weeks, 6 weeks, 9 weeks) and TREATMENT (resistance training with tDCS, resistance training with sham tDCS, standard care) will be used to determine the effect of the intervention on outcome measures (balance, gait, corticospinal function, strength, UPDRS score, blood oxygenation). Post-hoc analsyis using bonferoni correction will be applied as appropriate, and significance will be set at P less than 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/06/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
1/03/2018
Date of last data collection
Anticipated
Actual
1/06/2018
Sample size
Target
42
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292359 0
University
Name [1] 292359 0
Deakin University
Country [1] 292359 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood, Victoria, 3123
Country
Australia
Secondary sponsor category [1] 291040 0
None
Name [1] 291040 0
Address [1] 291040 0
Country [1] 291040 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293831 0
Deakin University Human Research Ethics Commitee
Ethics committee address [1] 293831 0
Ethics committee country [1] 293831 0
Australia
Date submitted for ethics approval [1] 293831 0
09/02/2015
Approval date [1] 293831 0
12/03/2015
Ethics approval number [1] 293831 0
2015-014

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

Contacts
Principal investigator
Name 61426 0
Dr Wei-Peng Teo
Address 61426 0
Deakin University, School of Exercise and Nutrition Science, 221 Burwood Hwy, Burwood, Victoria, 3123
Country 61426 0
Australia
Phone 61426 0
+61392445229
Fax 61426 0
+61392446017
Email 61426 0
[email protected]
Contact person for public queries
Name 61427 0
Ashlee Hendy
Address 61427 0
Deakin University, School of Exercise and Nutrition Science, 221 Burwood Hwy, Burwood, Victoria, 3123
Country 61427 0
Australia
Phone 61427 0
+61392446221
Fax 61427 0
Email 61427 0
[email protected]
Contact person for scientific queries
Name 61428 0
Ashlee Hendy
Address 61428 0
Deakin University, School of Exercise and Nutrition Science, 221 Burwood Hwy, Burwood, Victoria, 3123
Country 61428 0
Australia
Phone 61428 0
+61392446221
Fax 61428 0
Email 61428 0
[email protected]

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?

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
EmbaseConcurrent transcranial direct current stimulation and progressive resistance training in Parkinson's disease: Study protocol for a randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1461-7
N.B. These documents automatically identified may not have been verified by the study sponsor.