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Trial registered on ANZCTR


Registration number
ACTRN12617001514392
Ethics application status
Approved
Date submitted
25/10/2017
Date registered
30/10/2017
Date last updated
30/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving neural function through targeted exercise in older adults
Scientific title
A time-course analysis of acute and chronic neurophysiological and functional adaptations and retention following one session (acute) or 12 weeks (chronic) of externally-paced strength training, challenging balance training, or visuomotor training in older adults.
Secondary ID [1] 293187 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Ageing 305183 0
Maladaptive neuroplasticity 305184 0
Impaired functional performance 305185 0
Condition category
Condition code
Neurological 304499 304499 0 0
Studies of the normal brain and nervous system
Musculoskeletal 304500 304500 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled trial targeting community dwelling men and women aged 65+ years. The study consists of four groups: 1) Challenging balance; 2) Visuomotor (skill training); 3) Externally-paced strength training; and 4) Usual care control group. Due to limited availability of training facilities and human resources, the study will be conducted over two years, Data collection and the intervention will occur between January and June of 2013 and 2014, respectively. Participants recruited during year 1 will be randomly allocated to either intervention group 1 or 2, while participants recruited during year 2 will be randomly allocated to either intervention group 3 or 4.

Participants randomised to intervention group 1-3 will be asked to complete three 45-minute supervised training sessions per week for 12 weeks in a purpose-designed facility at Deakin University, Burwood, Victoria. All sessions will be administered as group training sessions, and supervised by the Principle Investigator (Bach Ex Sci (Hons)). Testing for the acute effects of the training sessions will occur at baseline, 5-minutes, 30-minutes, and 60-minutes post-completion of training session 1. Testing for the chronic effects of the training interventions will occur at baseline; and weeks 4, 8, and 12 throughout the intervention period, as well as at week 16 to evaluate the residual effects of the interventions.

Group 1 will be asked to complete four rounds of 12 x 30-second functional balance tasks with varying stance conditions (i.e. single or double-legged), vision (i.e. eyes open or eyes closed), and surface stability (i.e. rigid ground surface or dura-disc). Challenges in the form of a physical perturbation will be introduced to progressively overload the balance requirements of the tasks throughout the intervention period. This mode of training will involve approximately 24 minutes of 'work time' and 21 minutes of 'rest time' during the 45 minute session.

Group 2 will complete five rounds of eight visuomotor tracking conditions requiring participants to match dorsiflexion and plantarflexion ankle movements of varying ankle joint ranges of movement (from 60 to 120 degrees) and movement frequencies (from 0.2 to 1.4 Hz) to a target reference limb as displayed on a monitor. This mode of training will involve approximately 24 minutes of 'work time' and 21 minutes of 'rest time' during the 45 minute session.

Group 3 will complete four sets of five functional lower-limb strengthening exercises at a load of 8-12 repetition maximum in a dual-task condition involving external pacing with an audible metronome set to 60Hz. Four sets of 12 repetitions per exercise will involve approximately 24 minutes of 'work time' and 21 minutes of 'rest time' during the 45 minute session.

All training sessions will be conducted by the principle investigator, and adherence will be recorded on individual data record cards for each participant by the researcher.
Intervention code [1] 299440 0
Lifestyle
Intervention code [2] 299485 0
Treatment: Other
Comparator / control treatment
The usual care control group (group 4) will be a 'no treatment' group, thus participants will undergo testing at equivalent time points, whilst continuing their normal everyday activities.
Control group
Active

Outcomes
Primary outcome [1] 303736 0
Change in Motor Evoked Potential (MEP) amplitude measured using transcranial magnetic stimulation (TMS) to the tibialis anterior (TA) muscle of the dominant limb.
Timepoint [1] 303736 0
Acute effects: Baseline, 5 (primary), 30 and 60-minutes post-training session
Long-term effects: Baseline, 4 (primary), 8, 12 and 16 weeks after randomisation.
Primary outcome [2] 303737 0
Short-interval intracortical inhibition (SICI) measured with TMS targeting the TA muscle of the dominant limb.
Timepoint [2] 303737 0
Acute effects: Baseline, 5 (primary), 30 and 60-minutes post-training session
Long-term effects: Baseline, 4 (primary), 8, 12 and 16 weeks after randomisation.
Secondary outcome [1] 340018 0
Maximal compound muscle action potential (MMAX) of the tibialis anterior muscle measured with percutaneous peripheral nerve stimulation to the peroneal nerve.
Timepoint [1] 340018 0
Acute effects: Baseline, 5, 30 and 60-minutes post-training session
Long-term effects: Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [2] 340019 0
Muscle thickness of the left and right tibialis anterior muscle measured using an ultrasound
Timepoint [2] 340019 0
Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [3] 340020 0
Functional muscle power measured using an unassisted stair climb task (18 stairs with a 19 cm rise and 30 cm run).
Timepoint [3] 340020 0
Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [4] 340021 0
Aerobic endurance measured using the six minute walk test
Timepoint [4] 340021 0
Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [5] 340022 0
Dynamic knee extensor strength (1 repetition maximum) measured on a leg press machine.
Timepoint [5] 340022 0
Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [6] 340023 0
Isometric dorsiflexion strength measured using an isokinetic dynamometer.
Timepoint [6] 340023 0
Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [7] 340024 0
Isokinetic dorsiflexion torque measured using an isokinetic dynamometer.
Timepoint [7] 340024 0
Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [8] 340025 0
Static balance measured using single-leg conditions with eyes open or closed.
Timepoint [8] 340025 0
Acute effects: Baseline, 5, 30 and 60-minutes post-training session
Long-term effects: Baseline, 4, 8, 12 and 16 weeks after randomisation.
Secondary outcome [9] 340026 0
Dorsiflexion / plantarflexion movement variability measured with a single-axis goniometer and specialised visuomotor tracking software.
Timepoint [9] 340026 0
Acute effects: Baseline, 5, 30 and 60-minutes post-training session
Long-term effects: Baseline, 4, 8, 12 and 16 weeks after randomisation.

Eligibility
Key inclusion criteria
Community dwelling men and women who are right leg dominant (as determined by the Waterloo Footedness Questionnaire); free of any musculoskeletal injuries or neurological impairments; Mini Mental State Examination (MMSE) score >25 (no cognitive impairment); not taking any medications known to influence neurological function (e.g. antipsychotic, antidepressant, anxiety medications); and not participating in any organised training activities including strength training in the past 12 months.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Left leg dominant (as determined by the Waterloo Footedness Questionnaire); musculoskeletal injuries or pain that may be exacerbated by inclusion in the study; any medical condition that may be contraindicated for TMS (e.g. migraines, seizures); neurological impairments that may alter assessment of neurological function, including cognitive impairment (MMSE score <25); the use of medications known to influence neurological function (e.g. antipsychotic, antidepressant, anxiety medications); and participation in organised training activities including strength training within the last 12 months.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation performed using computerised sequence generation in Microsoft Excel software. Randomisation was stratified according to gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All the data will be analysed on a modified intention-to-treat basis, including all randomly assigned participants, regardless of exercise compliance, with at least one follow-up observation, using Stata (version 15). All data will be checked for normality prior to analysis. Time, group and group-by-time interactions will be examined using generalised linear mixed models with random intercepts fitted for each outcome, including fixed effects for time and an interaction between group and time. A secondary analysis will be run adjusting for baseline value of the outcome variable.

Sample size: Sample size estimates are based upon effect sizes observed for MEP amplitude and SICI in other studies, either performed in young adults or with a different mode of exercise (Cirillo et al. 2011, McDonnell et al. 2013) due to the lack of relevant studies in older adults or these particular interventions. A priori sample size calculations were performed for a repeated measures within-between group interaction analysis of covariance (ANCOVA) using G*Power version 3.1.9.2 (Kiel, Germany) . The number of groups arebadjusted from four (EP-ST; BAL; VIS; CTRL) to five (four experimental groups plus one covariate of baseline data); and it was estimated that a total of 10 per group would provide an actual power of 81% and 89% for the acute and chronic conditions respectively, to detect a moderate effect size of 0.4 between the training groups and controls for changes in MEP amplitude and SICI, assuming a type I error probability of 0.05 and based on four repeated observations (baseline, 5-minutes post; 30-minutes post; and 60-minutes post) and five repeated observations (baseline; 4-weeks; 8-weeks; 12-weeks; and 16-weeks), with a non-sphericity epsilon (e) correction of 1.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/06/2012
Date of last participant enrolment
Anticipated
Actual
30/12/2013
Date of last data collection
Anticipated
Actual
13/06/2014
Sample size
Target
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 17898 0
3125 - Burwood

Funding & Sponsors
Funding source category [1] 297815 0
University
Name [1] 297815 0
Deakin University
Country [1] 297815 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood
Victoria
3125
Country
Australia
Secondary sponsor category [1] 296857 0
None
Name [1] 296857 0
N/A
Address [1] 296857 0
N/A
Country [1] 296857 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298871 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 298871 0
Ethics committee country [1] 298871 0
Australia
Date submitted for ethics approval [1] 298871 0
04/06/2012
Approval date [1] 298871 0
14/06/2012
Ethics approval number [1] 298871 0
2012-103

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

Contacts
Principal investigator
Name 78506 0
Dr Ashleigh Moreland
Address 78506 0
Charles Sturt University
School of Exercise Science, Sport and Health
Panorama Avenue
Bathurst
NSW 2795
Country 78506 0
Australia
Phone 78506 0
+61 2 6338 4442
Fax 78506 0
Email 78506 0
amoreland@csu.edu.au
Contact person for public queries
Name 78507 0
Ashleigh Moreland
Address 78507 0
Charles Sturt University
School of Exercise Science, Sport and Health
Panorama Avenue
Bathurst
NSW 2795
Country 78507 0
Australia
Phone 78507 0
+61 2 6338 4442
Fax 78507 0
Email 78507 0
amoreland@csu.edu.au
Contact person for scientific queries
Name 78508 0
Ashleigh Weier
Address 78508 0
Charles Sturt University
School of Exercise Science, Sport and Health
Panorama Avenue
Bathurst
NSW 2795
Country 78508 0
Australia
Phone 78508 0
+61 2 6338 4442
Fax 78508 0
Email 78508 0
amoreland@csu.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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