ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000541707

Ethics application status

Approved

Date submitted

25/03/2022

Date registered

6/04/2022

Date last updated

20/05/2022

Date data sharing statement initially provided

6/04/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Upper limb resistance exercise biomechanics in older adults

Scientific title

Upper limb resistance exercise on peak muscle activation and range of motion in older adults

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Healthy aging

Prevention of muscular deconditioning

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will attend a single testing session, lasting for a maximum of 2 hours and will be asked to perform six different upper limb exercises, being a biceps curl, shoulder press, lateral raise, triceps extension, chest press and upright row. Peak upper limb muscle activation and range of motion will be measured during performance of the six exercises using three different types of resistance equipment (milk bottles, cable machine and theraband) with a resistance of 4kg. A single set of 10 repetitions will be performed for each exercise, for each item of equipment. Sessions will be conducted 1:1 by student exercise physiologists, under the supervision of an Accredited Exercise Physiologist. Following completion of each set, participants will be asked to rate their perceived exertion following the bout of exercise. The order of exercises and the order of equipment used will be randomised for each participant. No washout period will occur.

Intervention code [1]

Rehabilitation

Intervention code [2]

Prevention

Intervention code [3]

Treatment: Other

Comparator / control treatment

Prior to completing the intervention, participants will act as their own controls for the study. They will be asked to performed unweighted exercise (active range of motion, without equipment) to determine peak muscle activation and maximum joint range of motion at baseline. These results will act as a comparative, to determine the difference that the added resistance of the three pieces of equipment have on muscle activation and range of motion.

As part of the same 2 hour intervention period, participants will be asked to perform six different upper limb exercises, being a biceps curl, shoulder press, lateral raise, triceps extension, chest press and upright row using no resistance equipment. A single set of 10 repetitions will be performed for each exercise. Sessions will be conducted 1:1 by student exercise physiologists, under the supervision of an Accredited Exercise Physiologist. Following completion of the set, participants will be asked to rate their perceived exertion following the bout of exercise.

Control group

Active

Outcomes

Primary outcome [1]

Peak muscle activation of the pectoralis major, biceps brachii, triceps brachii, upper trapezius, latissimus dorsi and middle deltoid will be assessed using electromyography

Timepoint [1]

Monitored continuously (throughout each repetition) for the duration of each exercise.

Secondary outcome [1]

Reflective markers will be placed on the wrist, elbow, upper arm and shoulder to measure total range of motion, which will be quantified from the video recordings of the movements, using Kinovea software.

Timepoint [1]

Change in joint range of motion will be quantified by measuring the difference between starting position limb angles to end position limb angles, which will be monitored for the duration of each exercise.

Secondary outcome [2]

Rating of perceived exertion will be assessed using a Borg 6-20 Rating of Perceived Exertion scale

Timepoint [2]

Immediately following completion of each exercise

Eligibility

Key inclusion criteria

Adults 65 years or older
Ability to provide informed consent
No underlying musculoskeletal or neurological conditions, which would affect their ability to participate in resistance exercise

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

One or more of the American College of Sports Medicine contraindications to exercise testing have been met
Retinopathy
Physical limitations preventing performance of the required movements

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation sequences for each participant will be concealed in double opaque envelopes, with allocation off envelopes occurring in sequential order by time of attendance. Due to the nature of the study, researchers and participants will not be blinded to their allocation, as both will be aware of the type of equipment being used and the exercise they are being asked to perform.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The order of exercises and the order of resistance equipment used will be randomized for each participant, as there will be a learning effect as the exercise technique becomes more familiar to the participants. Each exercise will be assigned a number from 1-6, and each item of equipment with receive a number 1-3, with the randomisation sequence of exercises and equipment being generated by a website (randomizer.org). The assigning of numbers to the exercises and equipment will be done by a list randomizer (random.org/lists/) to ensure objectivity.

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Analysis will be conducted using de-identified data. Summary statistics will be generated for the variables collected in the study, using IBM SPSS software. Descriptive analysis will be performed on numerical demographical data and frequency analysis for all categorical demographic data. T-tests will be used to compare between variables. Descriptive statistics will be presented as mean ± standard deviation (SD), or median (interquartile range) where appropriate. An alpha of P < 0.05 will be used to denote statistical significance.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

25/03/2022

Date of last participant enrolment

Anticipated

30/06/2022

Actual

6/05/2022

Date of last data collection

Anticipated

30/06/2022

Actual

6/05/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3350 - Mount Helen

Recruitment postcode(s) [2]

3350 - Ballarat

Recruitment postcode(s) [3]

3350 - Ballarat Central

Funding & Sponsors

Funding source category [1]

University

Name [1]

Federation University Australia

Address [1]

PO Box 663 Ballarat VIC 3353

Country [1]

Australia

Primary sponsor type

University

Name

Exercise Science & Sport Discipline, Federation University Australia

Address

PO Box 663 Ballarat VIC 3353

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Federation University Australian Human Research Ethics Committee

Ethics committee address [1]

PO Box 663 Ballarat VIC 3353

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/11/2021

Approval date [1]

15/12/2021

Ethics approval number [1]

A21-174

Summary

Brief summary

As we age, the quality and strength of muscles and bone diminishes. Furthermore, changes in posture and musculoskeletal dysfunction, such as rotator cuff pathologies, can accelerate this deconditioning. Resistance training is recommended in older adults to try to slow the rate of decline and maintain strength and function, however the minimum National Physical Activity Guidelines are only being met by approximately 1 in 4 Australian older adults, with no indication that the resistance guidelines are being met. This project aims to investigate the most effective upper limb resistance exercise equipment to use for maximal range of motion and muscle activation of the targeted muscle(s) in older adults. Participants will be asked to attend a single testing session, where they will perform six upper limb exercises without resistance and then using elastic banding (Theraband), milk bottles and resistance machines. Total range of motion and muscle activity will be measured for each exercise, using each piece of resistance equipment, on the major muscles in the arms and chest. The order of exercise completion and the item of equipment used will be randomized between each participant. The results of this study will provide further insight for exercise professionals to prescribe home-based upper limb resistance exercises in older adults, taking into consideration the type of resistance equipment, that will allow for the greatest activation of the targeted muscle(s).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Jacqueline Pengelly

Address

Office 330 | Building P | Mt Helen Campus
PO Box 663 Ballarat VIC 3353

Country

Australia

Phone

+610353276933

Fax

j.pengelly@federation.edu.au

Contact person for public queries

Name

Jacqueline Pengelly

Address

Office 330 | Building P | Mt Helen Campus
PO Box 663 Ballarat VIC 3353

Country

Australia

Phone

+610353276933

Fax

j.pengelly@federation.edu.au

Contact person for scientific queries

Name

Jacqueline Pengelly

Address

Office 330 | Building P | Mt Helen Campus
PO Box 663 Ballarat VIC 3353

Country

Australia

Phone

+610353276933

Fax

j.pengelly@federation.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?

De-identified individual participant data will be made available upon written request to the PI and at the discretion of the PI.

When will data be available (start and end dates)?

Data will be available following publication of the study findings or 31/12/2023, whichever occurs first. Data will be available for 5 years after publication.

Available to whom?

Researchers with approved study proposals who are conducting IPD meta-analyses.

Available for what types of analyses?

Only to achieve the aims in the approved proposal, for IPD meta-analyses. Individual participant data will not be made available for inclusion or comparison to any similar studies.

How or where can data be obtained?

Data can be obtained via written contact from the PI, Dr Jacqueline Pengelly at j.pengelly@federation.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15563	Informed consent form					383827-(Uploaded-25-03-2022-12-11-50)-Study-related document.pdf
15564	Ethical approval					383827-(Uploaded-25-03-2022-12-12-26)-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.

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