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Trial registered on ANZCTR


Registration number
ACTRN12623000800628
Ethics application status
Approved
Date submitted
21/06/2023
Date registered
26/07/2023
Date last updated
26/07/2023
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Does real-time feedback enhance resistance training outcomes for older adults?
Scientific title
Does real-time feedback enhance resistance training outcomes for older adults?
Secondary ID [1] 309946 0
None
Universal Trial Number (UTN)
U1111-1294-0598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health-related decline with ageing 330426 0
Sarcopenia 330427 0
Condition category
Condition code
Musculoskeletal 327265 327265 0 0
Normal musculoskeletal and cartilage development and function
Musculoskeletal 327266 327266 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 327267 327267 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will perform three sets of 10 repetitions at 60% three-repetition maximum (3RM) on each exercise (leg press and bench press) following a standardized warm-up under one of the four conditions at each session (each session separated by at least four days). The standardized warm-up will include 5 minutes of stationary cycling followed by 2 sets of each exercise (ie. leg press and bench press) using the bar only.
All four "feedback" conditions will be completed in a randomized crossover order determined through computer-generated random numbering. For all conditions, participants will be instructed to be as “forceful and powerful” as possible during the concentric phase of each repetition. Concentric velocity will be measured for each repetition using a linear position transducer (GymAware). This system will be connected to an iPad that will display the mean concentric velocity for each repetition in real time. Participants will be “spotted” by a researcher at all times and feedback will be provided by a physiotherapist with over 15 years experience. The following modes of feedback will be provided at separate sessions (separated by four days):
a. Verbal kinematic feedback – in addition to the standard control instruction (i.e.” “…forceful and powerful”), a researcher will verbally state the mean concentric barbell velocity that was recorded on an iPad (see above) for each repetition at a volume slightly greater than conversation volume. The participants will not be able to see the screen (so they won't get visual feedback simultaneously).
b. Visual kinematic feedback - in addition to the standard control instruction, the participant will see a display of mean concentric velocity (m per second) directly in front of them (or above them for bench press). The display will be in large font, on an iPad that will be placed approximately 1 m away.
c. Verbal encouragement - in addition to the standard control instruction, a researcher will stand perpendicular to the subject and provide standardized verbally encouragingly statements during repetitions 2–9 (i.e., repetition 2: “Way to go!”; repetition 3: “Come on!”; repetition 4: “Good job!”; repetition 5: “Excellent!”; repetition 6: “Come on, push it!”; repetition 7: “Keep it up!”; repetition 8: “Push it!”; and repetition 9: “Let’s go!”). These phrases were chosen because they have previously been shown to improve physical performance. All verbal encouragement was at a volume slightly louder than normal conversation volume.
d. Control (no additional feedback) - participants will be instructed to be as “forceful and powerful” as possible during the concentric phase of each repetition.

Each session will last approximately 45 minutes.
Intervention code [1] 326365 0
Rehabilitation
Comparator / control treatment
Control condition – prior to each set, participants will be instructed to be as “forceful and powerful” as possible during the concentric phase of each repetition. No further instruction or feedback will be applied during training sets.
Control group
Active

Outcomes
Primary outcome [1] 335143 0
Mean and peak (this will be assessed as a composite outcome) concentric velocity will be measured for each repetition during training sessions using a linear position transducer (GymAware) to identify differences between control and feedback conditions.
Timepoint [1] 335143 0
Within each set within each of four training sessions
Secondary outcome [1] 423252 0
Perceived exertion – participants will rate their perceived exertion at the end of each set (Omni-res 0-10 scale) to identify whether different forms of feedback influence perceived exertion within session.
Timepoint [1] 423252 0
At the end of each set within each of the four training sessions
Secondary outcome [2] 423254 0
Motivation - the motivation subscale from the Dundee Stress State Questionnaire will be used to assess motivation at the start and end of each training session.
Timepoint [2] 423254 0
At the start and end of each of the four training sessions
Secondary outcome [3] 423255 0
Five time sit to stand (5xSTS) – assessed at baseline and at the end of each session to assess acute training effects on power/function.
Timepoint [3] 423255 0
Baseline and at the end of each of the four resistance training sessions
Secondary outcome [4] 423256 0
Maximal gait speed - assessed using the timed 10m walk test at baseline and at the end of each training session (ie. session 2-5) to assess acute training effects on power/function.
Timepoint [4] 423256 0
Baseline and at the end of each of the four resistance training sessions
Secondary outcome [5] 423257 0
Fatigue - participants will report their levels of fatigue (0-10 scale) 24 hours after each training session via an online form or paper form
Timepoint [5] 423257 0
24 hours after each of the four training sessions
Secondary outcome [6] 423999 0
Muscle soreness - participants will report their levels of muscle soreness (0-10 scale) 24 hours after each training session via an online form or paper form
Timepoint [6] 423999 0
24 hours after each of the four training sessions

Eligibility
Key inclusion criteria
Aged 65-85 years with at least 12 months of resistance training experience
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Orthopaedic surgery in the past 6-months, uncontrolled cardiovascular disease, cognitive impairment, progressive neurological condition, severe visual or hearing impairment that would limit ability to receive feedback.

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 but order of the interventions was randomly allocated
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. 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
Randomised crossover design so that all participants receive each of the four feedback conditions (including active control condition)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
An a priori power analysis was conducted (G*Power 3.1.9.7) to estimate sample size based on a similar study in young adults that identified a large effect size in of 1.11 between control and feedback conditions. Consequently, to identify a large effect (f = 0.5) between the control condition and any of the feedback conditions, a minimum sample size of 12 is required for a repeated measures MANOVA (a = 0.05, power = 0.8). We plan to recruit 16 participants to ensure adequate power and to account for participant drop-outs.

Data will be presented as mean ± standard deviation (SD) or mean difference ± 95% confidence intervals (95% CI). To ascertain statistically significant differences between feedback types for the primary outcome of velocity, linear mixed effect modelling will be utilised with feedback condition as a fixed effect and baseline performance (i.e., velocity, motivation) as covariates. Secondary outcomes (motivation, RPE, physical function, muscle soreness) will also be assessed using linear mixed effect modelling with feedback condition as a fixed effect and relative baseline performance (e.g., baseline 5xSTS) as covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
Date of last participant enrolment
Anticipated
16/10/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24964 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 40618 0
4012 - Wavell Heights
Recruitment postcode(s) [2] 40616 0
4014 - Banyo
Recruitment postcode(s) [3] 40617 0
4018 - Taigum
Recruitment postcode(s) [4] 40615 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 314125 0
University
Name [1] 314125 0
Australian Catholic University
Country [1] 314125 0
Australia
Primary sponsor type
Individual
Name
Dr Vaughan Nicholson
Address
School of Allied Health, Australian Catholic University 1100 Nudgee Road Banyo QLD 4014
Country
Australia
Secondary sponsor category [1] 316040 0
University
Name [1] 316040 0
Australian Catholic University
Address [1] 316040 0
1100 Nudgee Road Banyo QLD 4014
Country [1] 316040 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313261 0
Australian Catholic University HREC
Ethics committee address [1] 313261 0
Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 313261 0
Australia
Date submitted for ethics approval [1] 313261 0
28/04/2023
Approval date [1] 313261 0
15/06/2023
Ethics approval number [1] 313261 0
2023-3112H

Summary
Brief summary
Resistance training safely improves a range of outcomes in older adults, with high-velocity resistance training (HVRT) the most effective at improving power and function in this group. Improving power generation with training such as HVRT is critical for older adults because muscle power is more important than muscle strength for physical function, dynamic balance and reacting to a loss of balance to prevent a fall.

While HVRT is effective, the benefit of such training is partly dependent on maximising movement velocity. Providing augmented feedback during resistance training is effective at improving movement velocity, motivation, and functional performance in young adults, but the use of feedback during resistance training in older adults has not been studied. Feedback is an integral component of a physiotherapist’s tool kit to optimise interventions (e.g., providing verbal feedback during task practice) but evidence to support the efficacy of feedback during HVRT in older adults does not yet exist.

The proposed study will be the first to identify whether providing augmented feedback during resistance training enhances movement velocity in older adults. Based on the established benefits of adding targeted instruction or feedback to other physiotherapy interventions, and the identified benefits of velocity-based feedback in young adults, it is hypothesised that augmented feedback will improve movement velocity during training. Improved movement velocity should translate to greater power adaptations and functional improvements. If feedback is effective at improving within session performance in older adults, the benefits may be transferrable to other physiotherapy settings such as rehabilitation where improving muscle power and function is a priority for most patients. Importantly, if feedback influences perceived exertion/motivation, this has positive implications for exercise adherence.

The objectives of this study are to identify whether:
a. providing augmented feedback during a resistance training session increases barbell velocity in older adults
b. different types of augmented feedback (e.g., visual) optimise barbell velocity
c. provision of feedback influences motivation and perceived exertion in older adults
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127518 0
Dr Vaughan Nicholson
Address 127518 0
Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Country 127518 0
Australia
Phone 127518 0
+61 7 36237687
Fax 127518 0
Email 127518 0
vaughan.nicholson@acu.edu.au
Contact person for public queries
Name 127519 0
Dr Vaughan Nicholson
Address 127519 0
Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Country 127519 0
Australia
Phone 127519 0
+61 7 36237687
Fax 127519 0
Email 127519 0
vaughan.nicholson@acu.edu.au
Contact person for scientific queries
Name 127520 0
Dr Vaughan Nicholson
Address 127520 0
Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Country 127520 0
Australia
Phone 127520 0
+61 7 36237687
Fax 127520 0
Email 127520 0
vaughan.nicholson@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only (after deidentification)
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Researchers who provide a methodologically sound proposal (eg. for IPD meta-analyses)
Available for what types of analyses?
Only to achieve the aims related to the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Dr Vaughan Nicholson, vaughan.nicholson@acu.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19492Study protocol    386115-(Uploaded-21-06-2023-09-37-54)-Study-related document.docx



Results publications and other study-related documents

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