ANZCTR - Registration

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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]

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

Maladaptive neuroplasticity

Impaired functional performance

Condition category

Condition code

Neurological

Studies of the normal brain and nervous system

Musculoskeletal

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]

Lifestyle

Intervention code [2]

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]

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]

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]

Short-interval intracortical inhibition (SICI) measured with TMS targeting the TA muscle of the dominant limb.

Timepoint [2]

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]

Maximal compound muscle action potential (MMAX) of the tibialis anterior muscle measured with percutaneous peripheral nerve stimulation to the peroneal nerve.

Timepoint [1]

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]

Muscle thickness of the left and right tibialis anterior muscle measured using an ultrasound

Timepoint [2]