Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000556549
Ethics application status
Approved
Date submitted
19/04/2024
Date registered
2/05/2024
Date last updated
20/12/2024
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] 311946 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscular Strength
 333536 0
Cardiorespiratory Fitness
333537 0
Physical Activity Behaviours 333538 0
Healthy, recreationally active adults 333541 0
Perceptual Responses to Exercise 333542 0
Hormonal responses to exercise 333543 0
Condition category
Condition code
Musculoskeletal 330218 330218 0 0
Normal musculoskeletal and cartilage development and function
Cardiovascular 330219 330219 0 0
Normal development and function of the cardiovascular system
Metabolic and Endocrine 330220 330220 0 0
Normal metabolism and endocrine development and function
Mental Health 330221 330221 0 0
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 2-arm randomised parallel trial (HIMT [intervention] v. CT [comparator]).

What, how and where and when:
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). Exercise equipment (i.e., exercise selection) will vary fortnightly 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. 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 (‘very hard’) to ensure high-intensity activity. Participants will be familiarised with the RPE scale during baseline testing Days 2, 3 and 4.
Aerobic exercises (e.g., ergometer): Participants will be instructed to:
• “Work as hard as you can to maintain a =7/10 RPE”
• “You should not be able to hold a conversation during the work period”
• “You should be able to regain your breath within the rest period and move to the next station appropriately.”
Resistance exercises (e.g., weights or bodyweight) :
• “Aim to complete 10 reps using the heaviest weight you can for this rep range maintaining a = 7/10 RPE.”
• “Perform each exercise with at least a 2 second lower and 1 second lift.”
• “If you finish the 10 reps before the work period is over - that is okay you can rest for the remaining time rather than performing more reps if you achieved = 7/10 RPE.”
• “If you do not reach = 7/10 RPE by 10 reps, complete more reps so that you achieve this RPE, and then increase your external load for the next set as guided by your instructor (e.g., 9kg DB goblet squat, increase to 10kg DB goblet squat).”
• “You should aim to feel like you have 3 reps left in the tank for each set”.
10 reps was chosen to reflect common prescription in HIMT (i.e., ~10RM, strength-hypertrophy stimulus).
Tempo:
Aerobic exercises (e.g., ergometer): Participants will be instructed to:
• “Work as hard as you can to maintain a = 7/10 RPE”
Resistance exercises (e.g., weights or bodyweight) :
• “Perform each exercise with at least a 2 second lower and 1 second lift.”
This tempo is prescribed for resistance exercises 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 > 10 reps in the work period and remain at an RPE <7/10. Participants will be encouraged to increase this weight by approximately 5-10% (or at the discretion of the instructor) the next time that exercise is performed to achieve a rep range of 10 and RPE =7/RPE.
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 10 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 10 rep 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).
Intervention code [1] 328402 0
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. 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), . Exercise equipment (i.e., exercise selection) will vary fortnightly 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. 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 greater than or equal to 7/10 (‘very hard’) to ensure high-intensity activity. Participants will be familiarised with the RPE scale during baseline testing Days 2, 3 and 4.
Aerobic exercises (e.g., ergometer): Participants will be instructed to:
• “Work as hard as you can to maintain a greater than or equal to 7/10 RPE”
• “You should not be able to hold a conversation during the work period”
• “You should be able to regain your breath within the rest period and move to the next station appropriately.”
Resistance exercises (e.g., weights or bodyweight) :
• “Aim to complete 10 reps using the heaviest weight you can for this rep range maintaining a greater than or equal to 7/10 RPE.”
• “Perform each exercise with at least a 2 second lower and 1 second lift.”
• “If you finish the 10 reps before the work period is over - that is okay you can rest for the remaining time rather than performing more reps if you achieved greater than or equal to 7/10 RPE.”
• “If you do not reach greater than or equal to 7/10 RPE by 10 reps, complete more reps so that you achieve this RPE, and then increase your external load for the next set as guided by your instructor (e.g., 9kg DB goblet squat, increase to 10kg DB goblet squat).”
• “You should aim to feel like you have 3 reps left in the tank for each set”.
10 reps was chosen to reflect common prescription in HIMT (i.e., ~10RM, strength-hypertrophy stimulus).
Tempo:
Aerobic exercises (e.g., ergometer): Participants will be instructed to:
• “Work as hard as you can to maintain a greater than or equal to 7/10 RPE”
Resistance exercises (e.g., weights or bodyweight) :
• “Perform each exercise with at least a 2 second lower and 1 second lift.”
This tempo is prescribed for resistance exercises 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 > 10 reps in the work period and remain at an RPE <7/10. Participants will be encouraged to increase this weight by approximately 5-10% (or at the discretion of the instructor) the next time that exercise is performed to achieve a rep range of 10 and RPE greater than or equal to 7/RPE.
Participants will be encouraged to increase distance achieved on ergometers while maintain an RPE greater than or equal to 7/ 10.
Regression:
Participants will be encouraged to decrease the weights lifted during a work period when they are unable to complete 10 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 10 rep 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 greater than or equal to 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
Active

Outcomes
Primary outcome [1] 337970 0
Muscular Strength (lower body)
Timepoint [1] 337970 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Primary outcome [2] 338092 0
Muscular strength (upper body)
Timepoint [2] 338092 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [1] 433921 0
Cardiorespiratory Fitness
Timepoint [1] 433921 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [2] 433935 0
Anthropometry: Body Mass Index (BMI)
Timepoint [2] 433935 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [3] 433936 0
Body composition: Fat mass
Timepoint [3] 433936 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [4] 433940 0
Heart rate
Timepoint [4] 433940 0
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 [5] 433941 0
Perceived Recovery Status
Timepoint [5] 433941 0
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 [6] 433942 0
Perceived Pain
Timepoint [6] 433942 0
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] 433943 0
Session-Rating of Perceived Exertion
Timepoint [7] 433943 0
Post each acute exercise session at baseline and after 7-weeks training (test day 2, 3, 4),
post each training session
Secondary outcome [8] 433944 0
Exercise Enjoyment
Timepoint [8] 433944 0
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 [9] 433945 0
Subjective Training Quality
Timepoint [9] 433945 0
Post each acute exercise session at baseline and after 7-weeks training (test day 2, 3, 4),
post each training session
Secondary outcome [10] 433946 0
Physical Activity Behaviour
Timepoint [10] 433946 0
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 [11] 433947 0
Self-efficacy during physical activity
Timepoint [11] 433947 0
Baseline (day 1 testing), after 7-weeks training (day 1 testing), 4-weeks after completion of the training program
Secondary outcome [12] 433948 0
Behavioural regulation during exercise
Timepoint [12] 433948 0
Baseline (day 1 testing), after 7-weeks training (day 1 testing), 4-weeks after completion of the training program
Secondary outcome [13] 433949 0
Session attendance
Timepoint [13] 433949 0
At the completion of each exercise session
Secondary outcome [14] 433950 0
Exercise session compliance
Timepoint [14] 433950 0
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 [15] 433951 0
Training load completed
Timepoint [15] 433951 0
Volume-load will be recorded during each exercise session and finalised at the completion of each exercise session.
Secondary outcome [16] 434501 0
Anthropometry: Waist circumference
Timepoint [16] 434501 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [17] 434502 0
Anthropometry: Hip circumference
Timepoint [17] 434502 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [18] 434503 0
Anthropometry: Waist: Hip ratio
Timepoint [18] 434503 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [19] 434504 0
Body composition: Lean mass
Timepoint [19] 434504 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [20] 434505 0
Body composition: Bone mineral content
Timepoint [20] 434505 0
Baseline (testing day 1) after 7-weeks training (testing day 1)
Secondary outcome [21] 434506 0
Hormonal response to exercise (human growth hormone)
Timepoint [21] 434506 0
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 [22] 434507 0
Hormonal response to exercise (total testosterone)
Timepoint [22] 434507 0
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] 434508 0
Hormonal response to exercise (cortisol)
Timepoint [23] 434508 0
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] 434509 0
Hormonal response to exercise (testosterone: cortisol ratio)
Timepoint [24] 434509 0
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] 443405 0
Menstrual Cycle Symptoms
Timepoint [25] 443405 0
Secondary outcome [26] 443406 0
Menstrual Cycle Symptoms
Timepoint [26] 443406 0
Weekly during the 7-weeks of training
Secondary outcome [27] 443407 0
Confirmation of menstrual cycle phase (ovulation peak)
Timepoint [27] 443407 0
Weekly during the 7-weeks of training
Secondary outcome [28] 443408 0
Confirmation of menstrual cycle phase (ovulation peak)
Timepoint [28] 443408 0
One test per day (as per manufacturer’s instructions) commencing approximately day 10 of their menstrual cycle until a positive test is returned. This may happen 2-3 times during the trial.

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)
Following baseline testing, subjects will be stratified for sex and individually randomised at a ratio of 1:1 (computerised random number generator) into either a HIMT (n = 29), or CT (n = 29). An independent third party will generate a series of numbers via a computerised random number generator and another third party will allocate matched participant codes according to the random number sequence.
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 ). 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 an analysis of covariance (ANCOVA). Then a 2 x 2 (group x time) repeated measures ANCOVA 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 ANCOVA 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). The use of ANCOVA procedures will ensure the consideration of potential confounders in the analysis (i.e., age, sex, muscular strength) 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. A per-protocol analysis will also be performed for participants who meet sufficient adherence to the intervention. Adherence will be defined as completing 80% of exercise sessions (high attendance) (23 out of 28 total). This rate of completion (80%) has also been implemented in a previous HIMT study for a per protocol analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/06/2024
Actual
29/06/2024
Date of last participant enrolment
Anticipated
27/01/2025
Actual
2/08/2024
Date of last data collection
Anticipated
18/04/2025
Actual
13/11/2024
Sample size
Target
58
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 42366 0
2021 - Moore Park
Recruitment postcode(s) [2] 42367 0
2228 - Yowie Bay
Recruitment postcode(s) [3] 42368 0
2089 - Neutral Bay

Funding & Sponsors
Funding source category [1] 316286 0
University
Name [1] 316286 0
University of Technology Sydney
Country [1] 316286 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Country
Australia
Secondary sponsor category [1] 318473 0
Commercial sector/Industry
Name [1] 318473 0
Douglas Hanley Moir Pathology
Address [1] 318473 0
14 Giffnock Avenue, Macquarie Park NSW 2113
Country [1] 318473 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315102 0
UTS Human Research Ethics Committee
Ethics committee address [1] 315102 0
Ethics committee country [1] 315102 0
Australia
Date submitted for ethics approval [1] 315102 0
12/04/2024
Approval date [1] 315102 0
24/06/2024
Ethics approval number [1] 315102 0

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

Contacts
Principal investigator
Name 133686 0
Dr Lee Wallace
Address 133686 0
University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
Country 133686 0
Australia
Phone 133686 0
+61 2 8005 5555
Fax 133686 0
Email 133686 0
lee.wallace@uts.edu.au
Contact person for public queries
Name 133687 0
Lee Wallace
Address 133687 0
University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
Country 133687 0
Australia
Phone 133687 0
+61 2 8005 5555
Fax 133687 0
Email 133687 0
lee.wallace@uts.edu.au
Contact person for scientific queries
Name 133688 0
Lee Wallace
Address 133688 0
University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
Country 133688 0
Australia
Phone 133688 0
+61 2 8005 5555
Fax 133688 0
Email 133688 0
lee.wallace@uts.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?
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 (lee.wallace@uts.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.