Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001501831
Ethics application status
Approved
Date submitted
23/08/2021
Date registered
4/11/2021
Date last updated
17/01/2023
Date data sharing statement initially provided
4/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of resistance training prescription on muscle strength and health.
Scientific title
Are muscle strength and health improvements associated with the dose of resistance training in healthy untrained adults?
Secondary ID [1] 305015 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developing muscle strength 323186 0
Condition category
Condition code
Musculoskeletal 320770 320770 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo an 8-week resistance training (RT) intervention where they will attend the La Trobe University, Bendigo Campus three days per week which will be separated by a 48-hour recovery period. The intervention will be administered individually, although multiple participants might be completing the intervention at the same time. The RT sessions will be supervised by qualified personal with previous experience in implementing RT programs (exercise scientist, exercise physiologist, strength and conditioning coach), some of which will be members of the research team. The duration for each RT session will be approximately 50 minutes. All exercise sessions will be completed under supervision to allow adherence to the intervention to be assessed and monitored. The RT dose (sets × repetitions × number of exercises × intensity) has been equated between the two intervention groups, with the variation in the prescribed RT dose being 2.8%. Two ‘high dose’ RT interventions will be prescribed, the details of each intervention are provided below.

Intervention Group One: 50% 1RM, 2-sets of 14-repetitions across 6-exercises (bench Press, 45° leg press, smith machine seated overhead press, barbell biceps curl, calf raise, lat pulldown), 3-minutes rest between sets and exercises.
Total dose of RT = 8400.

Intervention Group Two: 80% 1RM, 3-sets of 6-repetitions across 6-exercises (bench Press, 45° leg press, smith machine seated overhead press, barbell biceps curl, calf raise, lat pulldown), 3-minutes rest between sets and exercises.
Total dose of RT = 8640.
Intervention code [1] 321415 0
Lifestyle
Comparator / control treatment
A third intervention group will be used as a comparator, the RT dose is considered 'low' when compared to intervention groups one and two. The exercise order, supervision, verbal feedback, and frequency of RT sessions will not differ between intervention groups. However, intervention group three will be prescribed one less exercise (calf raise) to maintain a reduced ‘dose’ of RT. As a result, the duration of each training session will be 30-40 minutes. The details of intervention group three are provided below.

Intervention Group Three: 80% 1RM, 2-sets of 6-repetitions across 5-exercises (bench Press, 45° leg press, smith machine seated overhead press, barbell biceps curl, lat pulldown), 3-minutes rest between sets and exercises.
Total dose of RT = 4800.
Control group
Active

Outcomes
Primary outcome [1] 328585 0
Changes in muscle strength for the upper limbs (chest) will be assessed via 1 repetition-maximum (1RM) testing using 1RM bench press.
Timepoint [1] 328585 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Primary outcome [2] 328586 0
Changes in fat mass (%) will be determined via dual-energy x-ray absorptiometry (DXA) scanning.
Timepoint [2] 328586 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Primary outcome [3] 328607 0
Arterial stiffness will be determined from an arterial waveform analysis test using a SphygomoCor XCEL.
Timepoint [3] 328607 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [1] 399630 0
Health related quality of life will be assessed by the Short-Form Health survey.
Timepoint [1] 399630 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [2] 399636 0
Health related quality of life will be assessed by the Physical Activity Enjoyment Scale questionnaire.
Timepoint [2] 399636 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [3] 401294 0
Health related quality of life will be assessed by the Exercise Feeling Inventory survey.
Timepoint [3] 401294 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [4] 401295 0
Health related quality of life will be assessed by the Profile of Moods State survey.
Timepoint [4] 401295 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [5] 401296 0
Blood pressure will be determined using a SphygomoCor XCEL while performing an arterial waveform analysis.
Timepoint [5] 401296 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [6] 401297 0
Through venous blood sampling, blood lipids will be determined.
Timepoint [6] 401297 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [7] 401298 0
Through venous blood sampling, blood glucose will be determined.
Timepoint [7] 401298 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [8] 401299 0
Through venous blood sampling, cortisol will be determined.
Timepoint [8] 401299 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [9] 401300 0
Through venous blood sampling, Interleukin 6 will be determined.
Timepoint [9] 401300 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [10] 401301 0
Through venous blood sampling, interleukin 9 will be determined.
Timepoint [10] 401301 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [11] 401302 0
Through venous blood sampling, HbA1c will be determined.
Timepoint [11] 401302 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [12] 402352 0
Changes in muscle strength for the lower limbs (thighs) will be assessed via 1 repetition-maximum (1RM) testing using 1RM leg press.
Timepoint [12] 402352 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [13] 402353 0
Changes in muscle strength for the upper limbs (shoulders) will be assessed via 1 repetition-maximum (1RM) testing using 1RM smith machine seated overhead press.
Timepoint [13] 402353 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [14] 402354 0
Changes in muscle strength for the upper limbs (arms) will be assessed via 1 repetition-maximum (1RM) testing using 1RM biceps curl.
Timepoint [14] 402354 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [15] 402355 0
Changes in muscle strength for the lower limbs (calf) will be assessed via 1 repetition-maximum (1RM) testing using 1RM calf raise.
Timepoint [15] 402355 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [16] 402356 0
Changes in muscle strength for the upper limbs (back) will be assessed via 1 repetition-maximum (1RM) testing using 1RM lat pulldown.
Timepoint [16] 402356 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.
Secondary outcome [17] 402357 0
Changes in lean body mass (kg) will be determined via dual-energy x-ray absorptiometry (DXA) scanning.
Timepoint [17] 402357 0
Within 7-days prior to commencement of intervention, and within 7-days after the final intervention session.

Eligibility
Key inclusion criteria
1) Male and females aged 18-65 years old.
2) Individuals not regularly performing resistance training.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Individuals performing resistance training more than once per week for the previous 6-weeks.
2) Individuals who are pregnant or within 12-months post-partum.
3) Individuals with severe movement or coordination disorders.
4) Individuals with cognitive impairments, or unable to understand written and verbal English.
5) Individuals consuming pre-workout and protein supplements.
6) Individuals who have contraindications to performing resistance exercise.

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)
Block randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Eligible participants will be stratified by sex and baseline maximal strength of the bench press relative to each participants body mass.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be randomised into one of three intervention groups. Intervention groups consist of 8-weeks of RT where the prescription of training variables (number of sets, repetitions, intensity, and exercises) vary between the three groups.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data recorded from this study will undergo an ANOVA repeated measures test; providing a comparison between pre-intervention and post-intervention measured between the three intervention groups. Normal distribution will be evaluated with Shapiro-Wilk test. If the ANOVA Repeated measures test violates the assumption of normal distribution, then Kruskal-Wallis test will be used, as this does not require the assumption of normality. Significance will be set at p < 0.05. Normally distributed data will be presented as mean (SD) while non-normally distributed data will be presented as median (interquartile ranges). In addition, effect sizes, standard mean and deviation will be calculated for each intervention group for pre- and post-intervention measures of muscle strength, vascular and cardiovascular measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/11/2021
Actual
3/01/2022
Date of last participant enrolment
Anticipated
2/12/2022
Actual
14/10/2022
Date of last data collection
Anticipated
9/12/2022
Actual
9/12/2022
Sample size
Target
105
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 34972 0
3550 - Bendigo
Recruitment postcode(s) [2] 34977 0
3551 - Axedale
Recruitment postcode(s) [3] 34978 0
3450 - Castlemaine
Recruitment postcode(s) [4] 34979 0
3463 - Maldon
Recruitment postcode(s) [5] 34980 0
3515 - Marong

Funding & Sponsors
Funding source category [1] 309404 0
University
Name [1] 309404 0
La Trobe University
Country [1] 309404 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Edwards Road, Flora Hill, 3552, Bendigo, Victoria.
Country
Australia
Secondary sponsor category [1] 310373 0
None
Name [1] 310373 0
Address [1] 310373 0
Country [1] 310373 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309210 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 309210 0
Ethics committee country [1] 309210 0
Australia
Date submitted for ethics approval [1] 309210 0
01/09/2021
Approval date [1] 309210 0
15/11/2021
Ethics approval number [1] 309210 0

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

Contacts
Principal investigator
Name 113354 0
A/Prof Brett Gordon
Address 113354 0
La Trobe University: Edwards Road, Flora Hill, 3552, Bendigo, Victoria.
Country 113354 0
Australia
Phone 113354 0
+61 3 54447680
Fax 113354 0
Email 113354 0
[email protected]
Contact person for public queries
Name 113355 0
Philip Lyristakis
Address 113355 0
La Trobe University: Edwards Road, Flora Hill, 3552, Bendigo, Victoria.
Country 113355 0
Australia
Phone 113355 0
+61 3 54447680
Fax 113355 0
Email 113355 0
[email protected]
Contact person for scientific queries
Name 113356 0
Philip Lyristakis
Address 113356 0
La Trobe University: Edwards Road, Flora Hill, 3552, Bendigo, Victoria.
Country 113356 0
Australia
Phone 113356 0
+61 3 54447680
Fax 113356 0
Email 113356 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?
Non-identifiable participant demographic data, pre- and post-intervention data, and training intervention data will be made available.
When will data be available (start and end dates)?
Within 12-months of publication with no end-date.
Available to whom?
Data will be made publicly available, members of the public and those within research communities will have access to both published and unpublished data which will not be identifiable.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Data will be made available on the La Trobe research repository, OPAL (Open at La Trobe).
https://opal.latrobe.edu.au


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.