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Trial registered on ANZCTR

Registration number

ACTRN12622001573741

Ethics application status

Approved

Date submitted

12/12/2022

Date registered

20/12/2022

Date last updated

10/12/2023

Date data sharing statement initially provided

20/12/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Acute Effects of Resistance Exercise with Intra-Set Rest in Older Adults

Scientific title

Acute Effects of Resistance Exercise with Intra-Set Rest on Physiological and Psychological Responses in Healthy Older Adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Fatigue

Physical performance

Condition category

Condition code

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The experimental session will be conducted in an exercise clinic at the University of Sydney Camperdown campus (Susan Wakil Health Building). Specifically, the experimental sessions will involve a 5-minute warm-up followed by 30 minutes spent performing the exercises (inclusive of resistance exercise and recovery times). All sessions will be supervised by an exercise physiologist or exercise scientist with one-on-one supervision provided to participants. There will be 7 days between the two experimental sessions (i.e., wash-out). Familiarisation will be conducted at end of an initial testing visit and will involve performing 2 sets of the chest press and the leg press following the exercise prescription used for the intra-set recovery (ISR) condition (details described below).

The ISR condition will involve 4 sets of 2 clusters of 5 repetitions at 70% one-repetition maximum (1RM) with 30 seconds of rest between clusters and 90 seconds of rest between sets. Participants will perform the chest press prior to the leg press (in this order). The warm-up during experimental sessions will involve completing 1 set of 8 repetitions for the exercises performed in the session (i.e., chest press or leg press) with a load equivalent to 40% of 1RM. After 2 minutes of rest following the warm-up, participants will commence the first set of the experimental condition. The Keiser A420 pneumatic (air resistance) equipment (Fresno, CA, USA) will be used for the chest press and leg press.

Participants will be instructed to refrain from moderate-vigorous exercise and any activities outside of daily living for the previous 72 hours prior to each session. Participants will also be asked not to start any other new exercise regimen or intentionally change their habitual diet throughout the entire study and assessment.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

The experimental session will be conducted in an exercise clinic at the University of Sydney Camperdown campus (Susan Wakil Health Building). Specifically, the experimental sessions will involve a 5-minute warm-up followed by 30 minutes spent performing the exercises (inclusive of resistance exercise and recovery times). All sessions will be supervised by an exercise physiologist or exercise scientist with one-on-one supervision provided to participants. There will be 7 days between the two experimental sessions (i.e., wash-out). Familiarisation will be conducted at end of an initial testing visit and will involve performing 2 sets of the chest press and the leg press following the exercise prescription used for the traditional (TRAD) condition (details described below).

The TRAD condition will involve 4 sets of 10 repetitions at 70% 1RM with 120 seconds of rest between sets. Participants will perform the chest press prior to the leg press (in this order). The warm-up during experimental sessions will involve completing 1 set of 8 repetitions for the exercises performed in the session (i.e., chest press or leg press) with a load equivalent to 40% of 1RM. After 2 minutes of rest following the warm-up, participants will commence the first set of the experimental condition. The Keiser A420 pneumatic (air resistance) equipment (Fresno, CA, USA) will be used for the chest press and leg press.

Participants will be instructed to refrain from moderate-vigorous exercise and any activities outside of daily living for the previous 72 hours prior to each session. Participants will also be asked not to start any other new exercise regimen or intentionally change their habitual diet throughout the entire study and assessment.

Control group

Active

Outcomes

Primary outcome [1]

Muscle force assessed by Keiser pneumatic equipment.

Timepoint [1]

Monitored continuously throughout resistance exercise.

Primary outcome [2]

Muscle power output assessed by Keiser pneumatic equipment.

Timepoint [2]

Monitored continuously throughout resistance exercise.

Primary outcome [3]

Velocity assessed by Keiser pneumatic equipment.

Timepoint [3]

Monitored continuously throughout resistance exercise.

Secondary outcome [1]

Muscle oxygenation assessed by near-infrared spectroscopy (NIRS).

Timepoint [1]

Monitored continuously for the duration of each exercise session, and immediately post-exercise.

Secondary outcome [2]

Muscle activation assessed by electromyography (EMG).

Timepoint [2]

Monitored continuously for the duration of each exercise session.

Secondary outcome [3]

Perceptual fatigue assessed using the Visual Analog Fatigue Scale (VAFS).

Timepoint [3]

Immediately post-exercise.

Secondary outcome [4]

Muscle soreness assessed by a visual analog scale with scores ranging from 0 to 100 measured in millimetres on a 10-cm vertical line using a pen.

Timepoint [4]

Assessed 7 days post-exercise session.

Secondary outcome [5]

Feeling responses assessed via the Feeling Scale (5-point Likert scale).

Timepoint [5]

Immediately pre-exercise and immediately post-exercise.

Secondary outcome [6]

Blood flow assessed by near-infrared spectroscopy (NIRS).

Timepoint [6]

Monitored continuously for the duration of each exercise session, and immediately post-exercise.

Secondary outcome [7]

Arousal response assessed by Felt Arousal Scale (6-point Likert scale)..

Timepoint [7]

Immediately pre-exercise and immediately post-exercise.

Secondary outcome [8]

Momentary activation assessed by Activation Deactivation Adjective Check List (4-point Likert scale).

Timepoint [8]

Immediately pre-exercise and immediately post-exercise.

Secondary outcome [9]

Mood assessed by Mood Survey Scale (5-point Likert scale).

Timepoint [9]

Immediately pre-exercise and immediately post-exercise.

Eligibility

Key inclusion criteria

Participants should be able to speak English.
Individuals with > 1 year experience in resistance training and have averaged at least 2 sessions of resistance training per week during the previous 6 weeks.
Participants need to be free of rotator cuff tear or history of any shoulder or back or lower extremity condition, injuries, surgeries, congenital malformations, back, knee, or hip osteoarthritis, recent fracture (12 months), cognitive impairment as defined by Montreal Cognitive Assessment score of 27-30.

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Acute or terminal illness, neuromuscular diseases or disorders, and any unstable or ongoing cardiovascular/respiratory disorders. Individuals taking medications considered to affect muscle performance (e.g., statin, diuretics) will be excluded from the study. Individuals with morbid obesity (BMI > 40).

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)

Participants will find out the order of the experimental protocols which will be determined by permuted block randomization (www.random.org).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Descriptive statistics will be calculated for mean power output, total power output, and velocity loss. The normality of the absolute data will be investigated using the Shapiro–Wilk test, and Levene’s test will be used to assess the homogeneity of variance. For normally distributed data, means ± standard deviation (SD) and confidence interval (95% CI) will be reported. For non-normally distributed data median and interquartile ranges will be reported. Conditions will be analyzed with a two-way analysis of variance (ANOVA) with repeated measures for normally distributed data and an appropriate non-parametric test for non-normally distributed data. The statistical tests will examine the differences in power maintenance (mean power output, total power output, and velocity loss) and muscle oxygenation (expressed as % tissue saturation index) in protocols.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

4/04/2023

Actual

24/10/2023

Date of last participant enrolment

Anticipated

1/04/2024

Actual

Date of last data collection

Anticipated

30/04/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science.
Level 6, Western Avenue, D18 - Susan Wakil Health Building, Camperdown, NSW, 2006.

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science.
Level 6, Western Avenue, D18 - Susan Wakil Health Building, Camperdown, NSW, 2006.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committe (HREC)

Ethics committee address [1]

Level 3, Michael Spence Building (F23), Corner of Eastern Avenue and City Road, University of Sydney, Camperdown, NSW 2006,

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/12/2022

Approval date [1]

28/06/2023

Ethics approval number [1]

Approval number: 2023/324

Summary

Brief summary

The primary aim of this acute study is to examine the acute effects of resistance exercise performed with ISR compared to TRAD on the maintenance of force, power output, and work, as well as differences between exercises targeting the upper and lower limbs. Secondary aims include whether better affective responses and less physiological and psychological fatigue can be achieved following resistance exercise using ISR compared to TRAD sets.

Hypotheses:
1. Resistance exercise performed with ISR will lead to higher mean force, power output, and work across the sets compared to resistance exercise performed with TRAD.
2. Resistance exercise performed with ISR will lead to lower perceived effort and more positive and less negative affective responses compared to resistance exercise performed with TRAD.
3. Resistance exercise performed with ISR will lead to greater muscle oxygenation and blood flow compared to resistance exercise performed with TRAD.
4. Muscle oxygenation and blood flow will explain a significant portion of the variance in power output, velocity, perceived effort, and affective responses between groups.
5. Similar responses for upper versus lower limb resistance exercises will be observed following the ISR and TRAD conditions.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Daniel Hackett

Address

The University of Sydney
Faculty of Medicine & Health, Sydney School of Health Sciences, Discipline of Exercise & Sport Science.
Level 6, Western Avenue, D18 - Susan Wakil Health Building, Camperdown, NSW, 2006

Country

Australia

Phone

+61 424133724

Fax

daniel.hackett@sydney.edu.au

Contact person for public queries

Name

Daniel Hackett

Address

Country

Australia

Phone

+61 424133724

Fax

daniel.hackett@sydney.edu.au

Contact person for scientific queries

Name

Daniel Hackett

Address

Country

Australia

Phone

+61 424133724

Fax

daniel.hackett@sydney.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?

All of the individual participant data collected during the trial, after de-identification.

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

Available for 5 years after publication (Starting on 1st December 2024 and ending on 30th November 2029).

Available to whom?

Case-by-case basis at the discretion of the Primary Sponsor.

Available for what types of analyses?

For IPD meta-analyses.

How or where can data be obtained?

Access is subject to approvals by Principal Investigator (Dr Daniel Hackett) daniel.hackett@sydney.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17851	Ethical approval				Will be available via an attachment.

Results publications and other study-related documents

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