ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Sarcopenia

Condition category

Condition code

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

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]

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]

Within each set within each of four training sessions

Secondary outcome [1]

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]

At the end of each set within each of the four training sessions

Secondary outcome [2]

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]

At the start and end of each of the four training sessions

Secondary outcome [3]

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]

Baseline and at the end of each of the four resistance training sessions

Secondary outcome [4]

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]

Baseline and at the end of each of the four resistance training sessions

Secondary outcome [5]

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]

24 hours after each of the four training sessions

Secondary outcome [6]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment postcode(s) [1]

4032 - Chermside

Recruitment postcode(s) [2]

4014 - Banyo

Recruitment postcode(s) [3]

4018 - Taigum

Recruitment postcode(s) [4]

4012 - Wavell Heights

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

1100 Nudgee Road Banyo QLD 4014

Country [1]

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]

University

Name [1]

Australian Catholic University

Address [1]

1100 Nudgee Road Banyo QLD 4014

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University HREC

Ethics committee address [1]

Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/04/2023

Approval date [1]

15/06/2023

Ethics approval number [1]

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

Dr Vaughan Nicholson

Address

Australian Catholic University
1100 Nudgee Road Banyo QLD 4014

Country

Australia

Phone

+61 7 36237687

Fax

[email protected]

Contact person for public queries

Name

Vaughan Nicholson

Address

Australian Catholic University
1100 Nudgee Road Banyo QLD 4014

Country

Australia

Phone

+61 7 36237687

Fax

[email protected]

Contact person for scientific queries

Name

Vaughan Nicholson

Address

Australian Catholic University
1100 Nudgee Road Banyo QLD 4014

Country

Australia

Phone

+61 7 36237687

Fax

[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?

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, [email protected])

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19492	Study protocol					386115-(Uploaded-21-06-2023-09-37-54)-Study-related document.docx

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.

Trial Review

Documents added manually

Documents added automatically