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Trial registered on ANZCTR

Registration number

ACTRN12624000556549p

Ethics application status

Submitted, not yet approved

Date submitted

19/04/2024

Date registered

2/05/2024

Date last updated

2/05/2024

Date data sharing statement initially provided

2/05/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

The Effects of Various High-Intensity Combined Resistance and Aerobic Training on Physical and Perceptual Outcomes in Recreationally Active Adults.

Scientific title

The Effects of High-Intensity Multimodal Training vs. Inter-session Concurrent Training on Physical Adaptations and Perceptual Responses in Recreationally Active Adults.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Muscular Strength

Cardiorespiratory Fitness

Physical Activity Behaviours

Healthy, recreationally active adults

Perceptual Responses to Exercise

Hormonal responses to exercise

Condition category

Condition code

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Cardiovascular

Normal development and function of the cardiovascular system

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

7-weeks of High-Intensity Multimodal Training (HIMT) or Inter-session Concurrent Training (CT).
This is a matched pair 2-arm randomised parallel trial (HIMT [intervention] v. CT [comparator]).

What, how and where and when:
The HIMT group will perform 4 HIMT sessions (i.e., combined high-intensity aerobic and resistance/ bodyweight exercise during a single session). The rationale for this frequency is to enable participants meet physical activity guidelines across both training modes.
Training sessions will vary each week to sustain variety and interest. Participants will be encouraged to take a rest day after 2 consecutive training days to promote appropriate recovery.

Training will be conducted face to face in small groups (3-8 participants) at participants' choice of training location:
- UTS Moore Park
- Neutral Bay F45
- Yowie Bay Scout Hall
In the event more than 8 participants are scheduled into a session, an additional instructor will be involved in session delivery to maintain this supervision ratio (1:8).

Training sessions will involve:
HIMT programs will be matched to the comparator for weekly frequency, duration (total and net work), exercise selection, and prescribed intensity. Participants will be asked to refrain from participation in additional high-intensity aerobic and/ or resistance exercise and competitive/ recreational sport during the study. HIMT programs will commence each session with a 5 minute warm up circuit using bodyweight resistance or 50% of working weight or ergometer resistance (for exercises using external weight or ergometers) involving all major muscle groups followed by dynamic stretching. Session instructors will then provide a group overview of the session format including exercise selection, order, approximate prescribed or target volume (determined from familiarisation sessions during baseline testing) and prescribed intensity (i.e., > 7/10 RPE). Instructors will clearly explain the session format (i.e., circuits), demonstrate each exercise and provide appropriate exercise technique cues. Sessions will finish with an instructor led 5 minute cool down including static stretching.

Frequency:
HIMT: 4 x 45 minute sessions/ week that are repeated
Session Duration:
Total 45 minutes (includes ~5 minute warm up and cool down)
Session Format:
Exercises will be performed in a circuit format during a session. Sessions may involve one or more circuits to ensure variety.
Exercise Selection:
Each training week will include the following movement patterns: hinge, squat, rotation, push, pull, hold. Exercise selection will change weekly to ensure variety and progressive overload. HIMT and comparator sessions in a training week will be matched for exercise selection.
Exercise Equipment:
HIMT and comparator programs will use the same exercise equipment as exercise selection is matched across a training week. All training locations will have access to the same equipment to ensure standardisation. Exercise equipment will include ergometer machine (e.g., cycle and row ergometers), free weights (e.g., dumbbells, kettlebells, medicine balls), battle ropes, exercise mats and resistance bands. Exercise equipment (i.e., exercise selection) will vary weekly to ensure variety.
Exercise Order:
Exercises will be ordered in a session to reduce fatigue across muscle groups (i.e., alternate lower body/ upper body exercises).
Prescribed Volume:
Total and net volume will be matched for HIMT and comparator protocols during a training week.
Time based volume prescription will be primarily utilised (e.g., 45 seconds of work with 15 seconds of rest to transition to next exercise. or 20 seconds of work with 10 seconds of rest to transition to next exercise. Work to rest ratios will vary throughout the program to ensure variety. Work to rest ratios will increase across the program as a means of progressive overload. The initial starting weights or ergometer resistance for participants will be prescribed by the student researcher based on the training volume-load completed in baseline testing/ familiarisation sessions.
Prescribed Intensity:
Participants will be instructed to work at an RPE > 7/ 10 to ensure high-intensity activity [3]. Participants will be familiarised with the RPE scale during baseline testing. Participants will be instructed to “perform as many reps as you can in each work period” for exercises not requiring equipment, “cover as much distance as you can in each work period” for exercises using ergometers or “select a weight that allows you to completed > 10-15 reps in the work period” for exercises using external weights (e.g., dumbbells). 10-15 reps chosen to reflect common prescription (i.e., >10RM, AMRAP style or strength-endurance stimulus).

Tempo:
Participants will be instructed to “perform as many reps as you can in each work period” for exercises not requiring equipment or “cover as much distance as you can in each work period” for exercises using ergometers indicating a fast tempo. However, participants will be asked to move at a tempo of no faster than 1s eccentric, 1s concentric for exercises using external weights (e.g., dumbbells) to ensure appropriate exercise technique and safety.
Monitored Volume:
The training volume-load (i.e., weight lifted in resistance exercises x reps completed or distance covered x ergometer resistance) will be recorded each session by research assistants (see exercise session recording template attached).
Monitored Intensity:
HR (continuously during), S-RPE (immediately post session)
Progressive Overload:
Participants will be encouraged to increase the weights lifted during a work period when they can complete > 15 reps in the work period for 2 consecutive work periods. Participants will be encouraged to increase this weight by approximately 5-10%.
Participants will be encouraged to increase distance achieved on ergometers while maintain an RPE >7/ 10.
Regression:
Participants will be encouraged to decrease the weights lifted during a work period when they are unable to complete 12 reps in the work period.
If a participant is observed to be working to fatigue or exhaustion, or with inappropriate technique instructors will advise the participant to reduce either:
- the external load (i.e., weights, ergometer resistance)
- the reps completed (while remaining in the prescribed >10RM range)
- tempo at which they are performing the exercise
- difficulty of the exercise (e.g., push up on toes may be regressed to kneeling push up)
Modifications/ scaling:
All exercises will be pre-prescribed with scaled alternatives available to suit varying abilities of participants and promote appropriate level of exercise intensity (e.g., kneeling push up, push up on toes, decline push up). Instructors will explain all alternatives when delivering the session overview and participants will be free to choose their starting point. Instructors may then encourage participants to progress or regress these alternatives based on the above progression/ regression methods.
In the event that a participant is unable to perform an exercise, instructors will modify the exercise based on pre-prescribed modifications to the program. Instructors will be provided with this information when they receive each training program. Instructors will record events of modification with the participants’ training volume-load diary for the session.
Supervision:
All training sessions will be completely supervised by qualified exercise professionals (i.e., ESSA AES, Personal Trainers). Third year sport and exercise science students undergoing their placement will assist in session instruction and training volume-load recording. Sessions will be performed in small groups of 3-8 participants (i.e., 1 research assistant: maximum 8 participants).
Encouragement/ motivation strategies:
Instructors will frequently use phrases such as “great work”, “keep it up”, among other positive phrases. These strategies will be anchored in instructors in a familiarisation session with the research student (TS) to ensure standardisation.
Exercise technique:
Appropriate exercise technique will be explained by instructors during the familiarisation sessions (baseline testing) and each time a novel exercise is introduced. Instructors will be educated on appropriate exercise technique in a familiarisation session with the research student (TS) to ensure standardisation.
Training location (physical environment):
All training locations are indoor, weather protected facilities. All locations will have access to the same training equipment to ensure standardisation across locations.
Music:
All training sessions will play background music >170bpm via a speaker.

Participants will perform 3 acute exercise sessions as part of baseline and post-training testing (HIMT, aerobic, resistance sessions). These sessions at baseline will serve as familiarisation sessions for exercise technique, equipment and intensity. Participants will undergo an anchoring exercise to familiarise themselves with S-RPE during these sessions.
Participants will be informed about the principles of progressive overload and will be encouraged to gradually increase aerobic and resistance training loads throughout the program while maintaining and RPE > 7/10 (i.e. high-intensity).

Who provided:
Training sessions will be designed by ESSA accredited exercise scientists (AES) (in collaboration with a Personal Trainer with extensive experience prescribing and delivering HIMT).
Training sessions will be supervised by ESSA AES, Personal trainers and trained instructors (third year Sport and Exercise Science undergraduate students) to ensure ongoing safety. Initial sessions will be supervised by the Principle Investigator and Research Student to ensure that all sessions are delivered to a consistent standard, thereafter trained instructors (third year undergraduate students) will assist in exercise session delivery.

How well:
Adherence to the intervention will be objectively measured via attendance sheets by the instructors at each training session.
Compliance to high-intensity exercise will be calculated according to the % of time spent at or above high-intensity of effort as defined by American College of Sports Medicine (ACSM).

Intervention code [1]

Lifestyle

Comparator / control treatment

What, how and where and when:
The CT group will perform a total of 4 sessions sessions; 2 aerobic and 2 resistance sessions per week. The rationale for this frequency is to enable participants meet physical activity guidelines across both training modes.
Training sessions will vary each week to sustain variety and interest. Participants will be encouraged to take a rest day after 2 consecutive training days to promote appropriate recovery. The CT group will perform the aerobic (n=2) and resistance (n=2) sessions in alternating order during a training week (i.e., resistance, aerobic, resistance, aerobic).

Training will be conducted face to face in small groups (3-8 participants) at participants' choice of training location:
- UTS Moore Park
- Neutral Bay F45
- Yowie Bay Scout Hall
In the event more than 8 participants are scheduled into a session, an additional instructor will be involved in session delivery to maintain this supervision ratio (1:8).

Training sessions will involve:
CT training programs will be matched to the intervention sessions in terms of weekly frequency, duration (total and net work), exercise selection, and prescribed intensity. Participants will be asked to refrain from participation in additional high-intensity aerobic and/ or resistance exercise and competitive/ recreational sport during the study. CT programs will commence each session with a 5 minute warm up circuit using bodyweight resistance or 50% of working weight or ergometer resistance (for exercises using external weight or ergometers) involving all major muscle groups followed by dynamic stretching. Session instructors will then provide a group overview of the session format including exercise selection, order, approximate prescribed or target volume (determined from familiarisation sessions during baseline testing) and prescribed intensity (i.e., > 7/10 RPE). Instructors will clearly explain the session format (i.e., circuits), demonstrate each exercise and provide appropriate exercise technique cues. Sessions will finish with an instructor led 5 minute cool down including static stretching.

Frequency:
CT: 2 x 45 minute aerobic + 2 x 45 minute resistance sessions/ week
Session Duration:
Total 45 minutes (includes ~5 minute warm up and cool down)
Session Format:
Exercises will be performed in a circuit format during a session. Sessions may involve one or more circuits to ensure variety.
Exercise Selection:
Each training week will include the following movement patterns: hinge, squat, rotation, push, pull, hold. Exercise selection for CT will change weekly to ensure variety and progressive overload. Sessions in a CT training week will be matched for exercise selection in the intervention programs (i.e., CT aerobic sessions will include the same aerobic exercises as the intervention sessions and CT resistance sessions will include the same resistance exercises as the intervention sessions).
Exercise Equipment:
CT and the intervention group will use the same exercise equipment as exercise selection is matched across a training week. All training locations will have access to the same equipment to ensure standardisation. Exercise equipment will include ergometer machine (e.g., cycle and row ergometers), free weights (e.g., dumbbells, kettlebells, medicine balls), battle ropes, exercise mats and resistance bands. Exercise equipment (i.e., exercise selection) will vary weekly to ensure variety.
Exercise Order:
Exercises will be ordered in a session to reduce fatigue across muscle groups (i.e., alternate lower body/ upper body exercises).
Prescribed Volume:
Total and net volume will be matched for CT and intervention protocols during a training week.
Time based volume prescription will be primarily utilised (e.g., 45 seconds of work with 15 seconds of rest to transition to next exercise. or 20 seconds of work with 10 seconds of rest to transition to next exercise. Work to rest ratios will vary throughout the program to ensure variety. Work to rest ratios will increase across the program as a means of progressive overload. The initial starting weights or ergometer resistance for participants will be prescribed by the student researcher based on the training volume-load completed in baseline testing/ familiarisation sessions.
Prescribed Intensity:
Participants will be instructed to work at an RPE > 7/ 10 to ensure high-intensity activity [3]. Participants will be familiarised with the RPE scale during baseline testing. Participants will be instructed to “perform as many reps as you can in each work period” for exercises not requiring equipment, “cover as much distance as you can in each work period” for exercises using ergometers or “select a weight that allows you to completed > 10-15 reps in the work period” for exercises using external weights (e.g., dumbbells). 10-15 reps chosen to reflect common prescription (i.e., >10RM, AMRAP style or strength-endurance stimulus).

Tempo:
Participants will be instructed to “perform as many reps as you can in each work period” for exercises not requiring equipment or “cover as much distance as you can in each work period” for exercises using ergometers indicating a fast tempo. However, participants will be asked to move at a tempo of no faster than 1s eccentric, 1s concentric for exercises using external weights (e.g., dumbbells) to ensure appropriate exercise technique and safety.
Monitored Volume:
The training volume-load (i.e., weight lifted in resistance exercises x reps completed or distance covered x ergometer resistance) will be recorded each session by research assistants (see exercise session recording template attached).
Monitored Intensity:
HR (continuously during), S-RPE (immediately post session)
Progressive Overload:
Participants will be encouraged to increase the weights lifted during a work period when they can complete > 15 reps in the work period for 2 consecutive work periods. Participants will be encouraged to increase this weight by approximately 5-10%.
Participants will be encouraged to increase distance achieved on ergometers while maintain an RPE >7/ 10.
Regression:
Participants will be encouraged to decrease the weights lifted during a work period when they are unable to complete 12 reps in the work period.
If a participant is observed to be working to fatigue or exhaustion, or with inappropriate technique instructors will advise the participant to reduce either:
- the external load (i.e., weights, ergometer resistance)
- the reps completed (while remaining in the prescribed >10RM range)
- tempo at which they are performing the exercise
- difficulty of the exercise (e.g., push up on toes may be regressed to kneeling push up)
Modifications/ scaling:
All exercises will be pre-prescribed with scaled alternatives available to suit varying abilities of participants and promote appropriate level of exercise intensity (e.g., kneeling push up, push up on toes, decline push up). Instructors will explain all alternatives when delivering the session overview and participants will be free to choose their starting point. Instructors may then encourage participants to progress or regress these alternatives based on the above progression/ regression methods.
In the event that a participant is unable to perform an exercise, instructors will modify the exercise based on pre-prescribed modifications to the program. Instructors will be provided with this information when they receive each training program. Instructors will record events of modification with the participants’ training volume-load diary for the session.
Supervision:
All training sessions will be completely supervised by qualified exercise professionals (i.e., ESSA AES, Personal Trainers). Third year sport and exercise science students undergoing their placement will assist in session instruction and training volume-load recording. Sessions will be performed in small groups of 3-8 participants (i.e., 1 research assistant: maximum 8 participants).
Encouragement/ motivation strategies:
Instructors will frequently use phrases such as “great work”, “keep it up”, among other positive phrases. These strategies will be anchored in instructors in a familiarisation session with the research student (TS) to ensure standardisation.
Exercise technique:
Appropriate exercise technique will be explained by instructors during the familiarisation sessions (baseline testing) and each time a novel exercise is introduced. Instructors will be educated on appropriate exercise technique in a familiarisation session with the research student (TS) to ensure standardisation.
Training location (physical environment):
All training locations are indoor, weather protected facilities. All locations will have access to the same training equipment to ensure standardisation across locations.
Music:
All training sessions will play background music >170bpm via a speaker.

Participants will perform 3 acute exercise sessions as part of baseline and post-training testing (HIMT, aerobic, resistance sessions). These sessions at baseline will serve as familiarisation sessions for exercise technique, equipment and intensity. Participants will undergo an anchoring exercise to familiarise themselves with S-RPE during these sessions.
Participants will be informed about the principles of progressive overload and will be encouraged to gradually increase aerobic and resistance training loads throughout the program while maintaining and RPE > 7/10 (i.e. high-intensity).

Who provided:
Training sessions will be designed by ESSA accredited exercise scientists (AES) (in collaboration with a Personal Trainer with extensive experience prescribing and delivering CT).
Training sessions will be supervised by ESSA AES, Personal trainers and trained instructors (third year Sport and Exercise Science undergraduate students) to ensure ongoing safety. Initial sessions will be supervised by the Principle Investigator and Research Student to ensure that all sessions are delivered to a consistent standard, thereafter trained instructors (third year undergraduate students) will assist in exercise session delivery.

How well:
Adherence to the intervention will be objectively measured via attendance sheets by the instructors at each training session.
Compliance to high-intensity exercise will be calculated according to the % of time spent at or above high-intensity of effort as defined by American College of Sports Medicine (ACSM).

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Muscular Strength (lower body)

Timepoint [1]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Primary outcome [2]

Muscular strength (upper body)

Timepoint [2]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [1]

Cardiorespiratory Fitness

Timepoint [1]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [2]

Anthropometry: Body Mass Index (BMI)

Timepoint [2]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [3]

Body composition: Fat mass

Timepoint [3]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [4]

Hormonal response to exercise (insulin-growth factor-1)

Timepoint [4]

Baseline and after 7-weeks training (testing day 2, 3, and 4: 10 mins pre and 30 mins post acute exercise session [HIMT, aerobic, resistance])

Secondary outcome [5]

Heart rate

Timepoint [5]

During cardiorespiratory fitness test (baseline and post-training tests Day 1), during acute training sessions (baseline and after 7-weeks training tests Day 2, 3, 4), during all training sessions

Secondary outcome [6]

Perceived Recovery Status

Timepoint [6]

Prior to each acute exercise session at baseline and after 7-weeks training (test day 2, 3, 4), prior to each training session

Secondary outcome [7]

Perceived Pain

Timepoint [7]

Prior to each acute exercise session at baseline and after 7-weeks training (test day 2, 3, 4), prior to each training session

Secondary outcome [8]

Session-Rating of Perceived Exertion

Timepoint [8]

Post each acute exercise session at baseline and after 7-weeks training (test day 2, 3, 4),
post each training session

Secondary outcome [9]

Exercise Enjoyment

Timepoint [9]

Post each acute exercise session at baseline and after 7-weeks training (test day 2, 3, 4), weekly during the 7-weeks of training, baseline (day 1 testing), after 7-weeks training (day 1 testing), 4-weeks after completion of the training program

Secondary outcome [10]

Subjective Training Quality

Timepoint [10]

Post each acute exercise session at baseline and after 7-weeks training (test day 2, 3, 4),
post each training session

Secondary outcome [11]

Physical Activity Behaviour

Timepoint [11]

Baseline (day 1 testing), after 7-weeks training (day 1 testing), 4-weeks after completion of the training program, weekly during the 7-weeks of training

Secondary outcome [12]

Self-efficacy during physical activity

Timepoint [12]

Baseline (day 1 testing), after 7-weeks training (day 1 testing), 4-weeks after completion of the training program

Secondary outcome [13]

Behavioural regulation during exercise

Timepoint [13]

Baseline (day 1 testing), after 7-weeks training (day 1 testing), 4-weeks after completion of the training program

Secondary outcome [14]

Session attendance

Timepoint [14]

At the completion of each exercise session

Secondary outcome [15]

Exercise session compliance

Timepoint [15]

Continuously during each exercise session (i.e., participant will be fitted with a HR monitor at the beginning of each exercise session and remove it at the completion of each exercise session). Compliance to be determined after the completion of each exercise session.

Secondary outcome [16]

Training load completed

Timepoint [16]

Volume-load will be recorded during each exercise session and finalised at the completion of each exercise session.

Secondary outcome [17]

Anthropometry: Waist circumference

Timepoint [17]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [18]

Anthropometry: Hip circumference

Timepoint [18]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [19]

Anthropometry: Waist: Hip ratio

Timepoint [19]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [20]

Body composition: Lean mass

Timepoint [20]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [21]

Body composition: Bone mineral content

Timepoint [21]

Baseline (testing day 1) after 7-weeks training (testing day 1)

Secondary outcome [22]

Hormonal response to exercise (human growth hormone)

Timepoint [22]

Baseline and after 7-weeks training (testing day 2, 3, and 4: 10 mins pre and 30 mins post acute exercise session [HIMT, aerobic, resistance])

Secondary outcome [23]

Hormonal response to exercise (total testosterone)

Timepoint [23]

Baseline and after 7-weeks training (testing day 2, 3, and 4: 10 mins pre and 30 mins post acute exercise session [HIMT, aerobic, resistance])

Secondary outcome [24]

Hormonal response to exercise (cortisol)

Timepoint [24]

Baseline and after 7-weeks training (testing day 2, 3, and 4: 10 mins pre and 30 mins post acute exercise session [HIMT, aerobic, resistance])

Secondary outcome [25]

Hormonal response to exercise (testosterone: cortisol ratio)

Timepoint [25]

Baseline and after 7-weeks training (testing day 2, 3, and 4: 10 mins pre and 30 mins post acute exercise session [HIMT, aerobic, resistance])

Eligibility

Key inclusion criteria

- Apparently healthy, recreationally active adults that have been participating in at least 30 minutes of moderate or 20 minutes of vigorous activity on at least 3 days per week for the last 6 months. At least 1 of these training sessions must be resistance training (e.g., lifting weights, bodyweight training). This is to ensure participants are accustomed to both aerobic and resistance exercise stimuli (at a level reaching physical activity guidelines) to account for the possible confounding effects of training status. 6 months was chosen as the minimum participation duration to be currently recreationally active as this is reflects a time period where individuals have participated long enough to experience possible health benefits. Approximately 50% of participants drop out within the first 6 months.
- Aged 18-65 years.
- Male and female.
- This study welcomes participants from Indigenous Australian backgrounds, those who identify as LGBTIQ+ and those form culturally and linguistically diverse backgrounds.
- Willingness to refrain from participating in additional forms of high-intensity activity or resistance exercise during the study (e.g., competitive or social sport, other group training, other high-intensity aerobic or resistance exercise),
- Willingness to give written informed consent and willingness to participate to and comply with the study.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Clinical populations (i.e., individuals requiring assessment and clearance to exercise by a health professional such as a general practitioner or exercise physiologist due to their condition or pathology) will be excluded.
- Individuals with metabolic or chronic disease, musculoskeletal injuries will be excluded.
- Individuals undergoing pharmacological treatment for psychological disorders will be excluded.
- Pregnant women will also be excluded.
- Individuals who participate in competitive/ recreational sport or training will be excluded as participants will be asked to refrain from additional high-intensity aerobic and/ or resistance exercise during the study.
- Anti-inflammatory and/or pharmacological treatment as this may interfere with inflammatory and metabolic blood markers and exercise adaptations. Exclusion based on these treatments will be done on a case-by-case basis. Treatments will be identified in the health pre-screening and participants will be excluded if there is evidence linking the treatment to changes in the physical and mental health markers that will be measured in this study.
- Contraindications to exercise as identified in the health pre-screening (Exercise and Sports Science Australia, Adult pre-exercise screening tool) (ESSA APSS).

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)

An independent third party will generate a series of numbers via a computerized random number generator and another third party will allocate matched participant codes according to the random number sequence.

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

Participants will be matched into pairs after baseline testing based on muscular strength, sex and age. Pairs will be randomly allocated using a computerised random number generator into either HIMT or CT group.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A priori sample size calculation was performed using G*Power software (Version 3.1). Power calculations were based on the primary outcome of muscular strength (alpha level = 0.05, power = 0.80, effect size 0.42 [Cohen’s f (V)]). The effect size (0.42) has been observed in previous research comparing examining the comparative effects of resistance protocols (low external load) for muscular strength. Sample size calculated to be total n = 47, n = 24 per group to detect small to medium effect size for the primary outcome measure (muscular strength). Assuming a drop out of ~20%, 29 participants per group is estimated, total n = 58.

Statistical analysis will be performed in R. Data will be presented as means ± SD. Comparisons will be made within groups and between groups (HIMT vs. CT). Male and female data will also be compared differences between gender groups. Data will be assessed for normality using the Shapiro-Wilk test. Initially, baseline data of the 2 groups will be compared using a multivariate one-way analysis of variance (MANOVA). Then a 2 x 2 (group x time) repeated measures MANOVA with a Bonferri post-hoc analysis will be used to determine differences within and between groups for physical outcomes (i.e., body composition, maximal strength, cardiorespiratory fitness). A 2 x 3 (group x time) repeated measures MANOVA with a Bonferri post-hoc analysis will be used to determine differences within and between groups for perceptual outcomes (i.e., exercise enjoyment, self-efficacy, behavioural regulation). Non-parametric tests will be used if data are not normally distributed (i.e., Kruskal-Wallis for baseline differences, Mann-Whitney test for between group comparisons). To control for possible confounders (e.g., mass, age, sex, previous exercise history) an MANCOVA analysis will be performed for each time endpoint. Significance will be accepted at p = 0.05. An intention to treat analysis will be performed, whereby participants will be analysed according to the group to which they are originally randomised. The online surveys completed at baseline, post-training and follow up also include open-ended questions. These responses will be analysed using qualitative content analysis techniques previously used in survey research. This will involve the coding of raw messages (i.e., open-ended responses) according to a classification scheme via an inductive approach.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

24/06/2024

Actual

Date of last participant enrolment

Anticipated

27/01/2025

Actual

Date of last data collection

Anticipated

18/04/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2021 - Moore Park

Recruitment postcode(s) [2]

2228 - Yowie Bay

Recruitment postcode(s) [3]

2089 - Neutral Bay

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Technology Sydney

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Technology Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

UTS Human Research Ethics Committee

Ethics committee address [1]

https://www.uts.edu.au/research-and-teaching/research/our-approach/ethics-and-integrity/human-research-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/04/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

High-Intensity Multimodal Training (HIMT) has recently gained interest as a proposed time-efficient method of meeting physical activity guidelines. Previous studies have demonstrated positive effects of HIMT on physical health and perceptual outcomes. However, the magnitude of these effects in HIMT remains unclear when compared to other methods of combined aerobic and resistance training (i.e., inter-session concurrent training [CT]). This may be due to a lack of standardisation in the prescription and reporting of training variables in HIMT. Therefore, the purpose of this study is to compare the effects of 7-weeks of HIMT and inter-session CT (on separate days to match physical activity guidelines) on physical and perceptual responses. This study will also compare physical activity behaviours prior, during and following the intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lee Wallace

Address

University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021

Country

Australia

Phone

+61 2 8005 5555

Fax

[email protected]

Contact person for public queries

Name

Lee Wallace

Address

University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021

Country

Australia

Phone

+61 2 8005 5555

Fax

[email protected]

Contact person for scientific queries

Name

Lee Wallace

Address

University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021

Country

Australia

Phone

+61 2 8005 5555

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 de-identification

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

Immediately following publication, no end date

Available to whom?

De-identified data may be provided on written request to the principle investigator and will provided on a case-by-case basis

Available for what types of analyses?

Meta-analysis

How or where can data be obtained?

Access subject to approvals by Principal Investigator: Dr Lee Wallace ([email protected])

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.

Trial Review

Documents added manually

Documents added automatically