Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000153112p
Ethics application status
Submitted, not yet approved
Date submitted
5/06/2018
Date registered
4/02/2019
Date last updated
17/01/2020
Date data sharing statement initially provided
4/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can thinking about movement improve strength and walking speed?
Scientific title
Does 4 weeks of motor imagery training improve leg strength and gait speed in older adults?
Secondary ID [1] 295100 0
None
Universal Trial Number (UTN)
U1111-1215-2447
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly 308173 0
Sarcopenia 308174 0
Musculoskeletal 308452 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307209 307209 0 0
Physiotherapy
Musculoskeletal 307433 307433 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motor imagery (mental practice). Participants in the motor imagery group will undertake 15 minutes of motor imagery practice five days per week for four weeks (20 sessions in total). The motor imagery training will be guided by pre-recorded audio files uploaded onto a portable musci player. The audio files will be designed specifically for this study. The motor imagery tasks will relate to muscle contractions and everyday weight bearing movements. The movements will relate to tasks such as rising from a chair, walking and turning. The training will be unsupervised, except for the first session when it will be supervised by a physiotherapist. Adherence will monitored by a patient diary and also by the number of times a track has been played on the audio device. After four weeks, outcome measures will be re-assessed and then those in the intervention group will crossover to the control group for four weeks before a final re-assessment.
Intervention code [1] 301431 0
Rehabilitation
Intervention code [2] 301607 0
Prevention
Comparator / control treatment
Active control group: this group will continue with the usual activities for four weeks. After four weeks, outcome measures will be re-assessed and then those in the control group will crossover to the intervention group for four weeks before a final re-assessment.
Control group
Active

Outcomes
Primary outcome [1] 306151 0
Isometric knee extension strength (measured with a digital hand-held dynamometer)
Timepoint [1] 306151 0
Baseline, four weeks post-enrollment (primary time point) and eight weeks post-enrollment
Primary outcome [2] 306153 0
Gait speed - measured over 8 metres using GAITRite system
Timepoint [2] 306153 0
Baseline, four weeks post-enrollment (primary time point) and eight weeks post-enrollment
Secondary outcome [1] 347738 0
The Short Activities-specific Balance Confidence (ABC-6) Scale
Timepoint [1] 347738 0
Baseline, four weeks post-enrollment and eight weeks post-enrollment
Secondary outcome [2] 347739 0
Timed up and go - measured with a stop watch, using a standard arm chair (height 42cm), the mean of three trials will be used for analysis
Timepoint [2] 347739 0
Baseline, four weeks post-enrolment and eight weeks post-enrolment

Eligibility
Key inclusion criteria
Aged at least 65 years
Independent community dwelling and willing to be randomised and commit to the study requirements
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Impaired cognition (MMSE <24/30)
Profound hearing loss
Acute or terminal illness
Unstable or ongoing cardiovascular and/or respiratory disorder, neurological disease or impairment, joint replacement surgery in the past six months, or the inability to commit to a period of time equivalent to the duration of the study

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



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were conducted using G*power 3.1 based on previous motor imagery and gait related studies in older adults. Repeated measures ANOVA will be used to identify differences in strength gained between groups from baseline to week four and eight

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2020
Actual
Date of last participant enrolment
Anticipated
19/10/2020
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22877 0
4014 - Banyo
Recruitment postcode(s) [2] 22878 0
4013 - Northgate

Funding & Sponsors
Funding source category [1] 299681 0
University
Name [1] 299681 0
Australian Catholic University
Country [1] 299681 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Road, Banyo, QLD, 4014
Country
Australia
Secondary sponsor category [1] 299018 0
None
Name [1] 299018 0
Address [1] 299018 0
Country [1] 299018 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300582 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 300582 0
Ethics committee country [1] 300582 0
Australia
Date submitted for ethics approval [1] 300582 0
23/05/2018
Approval date [1] 300582 0
Ethics approval number [1] 300582 0

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

Contacts
Principal investigator
Name 84122 0
Dr Vaughan Nicholson
Address 84122 0
School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014
Country 84122 0
Australia
Phone 84122 0
+61 7 36237687
Fax 84122 0
Email 84122 0
[email protected]
Contact person for public queries
Name 84123 0
Vaughan Nicholson
Address 84123 0
School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014
Country 84123 0
Australia
Phone 84123 0
+61 7 36237687
Fax 84123 0
Email 84123 0
[email protected]
Contact person for scientific queries
Name 84124 0
Vaughan Nicholson
Address 84124 0
School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014
Country 84124 0
Australia
Phone 84124 0
+61 7 36237687
Fax 84124 0
Email 84124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal or require further data for systematic review/meta analysis purposes
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator


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
No additional documents have been identified.