Trial Review

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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
Date results information initially provided
20/05/2022
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] 306772 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy aging 325785 0
Prevention of muscular deconditioning 325860 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323124 323124 0 0
Other physical medicine / rehabilitation
Musculoskeletal 323172 323172 0 0
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] 323225 0
Rehabilitation
Intervention code [2] 323252 0
Prevention
Intervention code [3] 323253 0
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] 330894 0
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] 330894 0
Monitored continuously (throughout each repetition) for the duration of each exercise.
Secondary outcome [1] 407954 0
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] 407954 0
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] 407956 0
Rating of perceived exertion will be assessed using a Borg 6-20 Rating of Perceived Exertion scale
Timepoint [2] 407956 0
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
29
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 37164 0
3350 - Ballarat
Recruitment postcode(s) [2] 37223 0
3350 - Ballarat Central
Recruitment postcode(s) [3] 37163 0
3350 - Mount Helen

Funding & Sponsors
Funding source category [1] 311111 0
University
Name [1] 311111 0
Federation University Australia
Country [1] 311111 0
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] 312447 0
None
Name [1] 312447 0
None
Address [1] 312447 0
None
Country [1] 312447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310641 0
Federation University Australian Human Research Ethics Committee
Ethics committee address [1] 310641 0
PO Box 663 Ballarat VIC 3353
Ethics committee country [1] 310641 0
Australia
Date submitted for ethics approval [1] 310641 0
16/11/2021
Approval date [1] 310641 0
15/12/2021
Ethics approval number [1] 310641 0
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 118366 0
Dr Jacqueline Pengelly
Address 118366 0
Office 330 | Building P | Mt Helen Campus
PO Box 663 Ballarat VIC 3353
Country 118366 0
Australia
Phone 118366 0
+610353276933
Fax 118366 0
Email 118366 0
j.pengelly@federation.edu.au
Contact person for public queries
Name 118367 0
Dr Jacqueline Pengelly
Address 118367 0
Office 330 | Building P | Mt Helen Campus
PO Box 663 Ballarat VIC 3353
Country 118367 0
Australia
Phone 118367 0
+610353276933
Fax 118367 0
Email 118367 0
j.pengelly@federation.edu.au
Contact person for scientific queries
Name 118368 0
Dr Jacqueline Pengelly
Address 118368 0
Office 330 | Building P | Mt Helen Campus
PO Box 663 Ballarat VIC 3353
Country 118368 0
Australia
Phone 118368 0
+610353276933
Fax 118368 0
Email 118368 0
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.TypeCitationLinkEmailOther DetailsAttachment
15563Informed consent form    383827-(Uploaded-25-03-2022-12-11-50)-Study-related document.pdf
15564Ethical 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.