Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000483853
Ethics application status
Approved
Date submitted
15/01/2021
Date registered
26/04/2021
Date last updated
18/10/2022
Date data sharing statement initially provided
26/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of two group-based exercise programs (team-sport vs. circuit training) on quality of life in adult men.
Scientific title
A comparison of two group-based exercise programs (team-sport vs. circuit training) on quality of life in adult men.
Secondary ID [1] 302714 0
None
Universal Trial Number (UTN)
U1111-1260-8686
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 320721 0
Condition category
Condition code
Public Health 317568 317568 0 0
Health promotion/education
Musculoskeletal 317570 317570 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 318565 318565 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of two exercise groups, a team-sport program (TS) or a group-circuit exercise program (CT). TS is the 'intervention' for this investigation. The exercise session will last 60-minutes and be undertaken twice weekly for 12 weeks. There will be at least 48 hours of recovery between each training session and will occur at the same time of day. Each session will comprise of a 45-minute conditioning phase, which will begin/end with a 5-10-minute warm-up/cool-down. The warm-up/cool-down will consist of light aerobic exercises and dynamic movements/stretches. All sessions will be supervised by a qualified exercise professional.

The TS sessions will be focused on developing Australian Football (AF) skills and gameplay. AF was selected as the team-sport focus as it has the potential to attract sedentary Australian males due to its popularity, particularly among middle-aged males, and as it has been found to have the strongest loyalty of all sports within Australia. Given the participant's insufficiently active nature, the first two weeks of the 12-week program will progressively re-introduce exercise and movement and develop participants' capabilities to jog, jump, land, stop, and change direction safely. This is intended to reduce the likelihood of injury. Across week 3 to 12 of the program the first weekly session will be a ‘training session’ that progressively build in physicality and difficulty to teach participants AF skills. The second weekly session will have participants playing a small-sided version of AF, AFL9s. AFL9s features modified rules more appropriate for the physical capacity and skill level of the sedentary individuals (e.g. non-contact, nine-a-side and feature two 20-minute halves). 18 participants will form a training session, and be divided each week into two teams of 9 to play the AFL9s match. For participants' safety, they will be requested to participate at a light-intensity (11/20 rating of perceived exertion (RPE)) before progressing to a moderate intensity (13-14/20 RPE) by week 3-4. This correlates with moderate-intensity which is recommended by the Australian Adult Pre-Exercise Screening System given the participants' low activity levels. Further progression in intensity will be done at the discretion of the Exercise Scientist. Session attendance will be monitored through a session attendance checklist.
Intervention code [1] 318991 0
Lifestyle
Intervention code [2] 318992 0
Treatment: Other
Comparator / control treatment
The exercise sessions for participants assigned to CT will comprise of both aerobic and resistance-based exercises performed in a circuit. The aerobic exercises will be orientated around the use of minimal equipment, such as brisk walking, jogging, jumping jacks, and the resistance-based exercises will have a multi-joint, whole-body focus, adhering to the American College of Sports Medicine Guidelines. Resistance exercise will include, but not be limited to bodyweight squats, squat press, kettlebell deadlift, dead-bug. Aerobic exercises will be performed for 30 seconds each, and resistance exercises for 30 seconds at a 2-second repetition rate to ensure 15 repetitions completed per station. A 30-second rest will be provided between each exercise. The circuit will be completed 3 times with a 210-second rest between each rotation. Participants will be asked to initially exercise at a low-intensity (11/20 RPE), but progress to moderate intensity (13-14 RPE) week 3-4. This correlates with moderate-intensity which is recommended by the Australian Adult Pre-Exercise Screening System given the participant's low activity levels. Further progression in intensity will be done at the discretion of the Exercise Scientist. Exercise intensity will be gradually progressed through exercise modification and adding additional load. Example of exercise modification includes transitioning from bodyweight squat to goblet squat and glute bridge to kettlebell deadlift. Session attendance will be monitored through a session attendance checklist.
Control group
Active

Outcomes
Primary outcome [1] 325612 0
Health-Related Quality of Life
Participants Health-related Quality of Life (HRQoL) will be assessed using the Short Form 36 Health Survey.
Timepoint [1] 325612 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program, primary endpoint), 3 months post-intervention completion (follow-up).
Secondary outcome [1] 388558 0
Exercise Motivation
Motivation to undertake exercise as assessed by the Behavioural Regulation in Exercise Scale Version 3.
Timepoint [1] 388558 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [2] 388559 0
Psychological Needs
The satisfaction of exercise-related Psychological Needs assessed using the Psychological Need Satisfaction in Exercise scale. The scale will assess the extent to which the exercise programs satisfy the participant's feelings of autonomy, competency, and relatedness.
Timepoint [2] 388559 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [3] 388560 0
Sedentary time
Sedentary time will be assessed using Axivity AX3 accelerometers. Participants will wear the wrist-worn device for 7-consecutive days. During this period they will complete a brief diary each day in which they record the time they went to sleep and woke each day, whether they napped, and for how long and whether the device was removed (including reason and duration). Data obtained within the diary can be used to delineate sedentary time from sleep or non-wear time.
Timepoint [3] 388560 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [4] 391872 0
Light Physical Activity
Time spent undertaking Light Physical Activity will be assessed using Axivity AX3 accelerometers. Participants will wear the wrist-worn device for 7-consecutive days.
Timepoint [4] 391872 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [5] 391873 0
Moderate/Vigorous Physical Activity (MVPA)
Time spent undertaking MVPA will be assessed using Axivity AX3 accelerometers. Participants will wear the wrist-worn device for 7-consecutive days.
Timepoint [5] 391873 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [6] 391874 0
Sleep
The duration of sleep will be assessed using Axivity AX3 accelerometers. Participants will wear the wrist-worn device for 7-consecutive days. During this period they will complete a brief diary each day in which they record the time they went to sleep and woke each day, whether they napped, and for how long and whether the device was removed (including reason and duration). Data obtained within the diary can be used to delineate sleep from sedentary time and non-wear time.
Timepoint [6] 391874 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [7] 391927 0
Total Cholesterol (TC)
A small sample of blood (0.04mL) will be collected via fingerstick of the non-dominant hand after a 12-hour overnight fast. This sample will be analysed using an Alere Cholestech LDX system to measure the participant's total cholesterol.
Timepoint [7] 391927 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [8] 391928 0
Triglyceride (TG)
A small sample of blood (0.04mL) will be collected via fingerstick of the non-dominant hand after a 12-hour overnight fast. This sample will be analysed using an Alere Cholestech LDX system to measure the participant's triglyceride level.
Timepoint [8] 391928 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [9] 391929 0
High-Density Lipoprotein (HDL)
A small sample of blood (0.04mL) will be collected via fingerstick of the non-dominant hand after a 12-hour overnight fast. This sample will be analysed using an Alere Cholestech LDX system to measure the participant's high-density lipoprotein level.
Timepoint [9] 391929 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [10] 391930 0
Low-Density Lipoprotein
A small sample of blood (0.04mL) will be collected via fingerstick of the non-dominant hand after a 12-hour overnight fast. This sample will be analysed using an Alere Cholestech LDX system to estimate the participant’s low-density lipoprotein level. The Cholestech LDX uses the Friedewald formula to estimate LDL from direct measurements of TC, TG and HDL cholesterol (LDL = TC-HDL-VLDL; where VLDL =TG/2.2).
Timepoint [10] 391930 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [11] 391931 0
Glucose
A small sample of blood (0.04mL) will be collected via fingerstick of the non-dominant hand after a 12-hour overnight fast. This sample will be analysed using an Alere Cholestech LDX system to measure the participant's blood glucose level.
Timepoint [11] 391931 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [12] 391932 0
Blood Pressure
Blood pressure will be assessed on the left arm following a 5 to 10-minute rest in a seated upright position.
Timepoint [12] 391932 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [13] 391933 0
Body Mass Index (BMI)
Participants BMI will be determined based on weight (kg) divided by height (m) squared. Weight will be measured with minimal clothing using an electronic scale. Height will be measured using a stadiometer to the nearest 0.1cm.
Timepoint [13] 391933 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [14] 391935 0
Waist Circumference
Waist circumference will be measured using a tape measure placed at the obvious narrowing of the waist. If no obvious narrowing is present, then the measure will be taken at the half-way point between the iliac crest and the inferior border of the 10th costal. The measurement will be read at the end of a normal expiration.
Timepoint [14] 391935 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [15] 391936 0
Metabolic Syndrome Risk
A continuous Metabolic Syndrome (MetS) Risk Score will be determined for each participant. This will be calculated using the following measures: resting systolic blood pressure, triglyceride, high-density lipoprotein, glucose, and waist circumference.
Timepoint [15] 391936 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program), 3 months post-intervention completion (follow-up).
Secondary outcome [16] 391937 0
Heart Rate
Training session intensity will be determined objectively through heart rate. Average heart rate, peak heart rate, and time spent in specific heart rate zones will be assessed (based on age-predicted maximum heart rate (208-0.7*age). Heart rates will be obtained using Polar M400 heart rate monitors during their two weekly training sessions in week 3 and 11 of the program.
Timepoint [16] 391937 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program)
Secondary outcome [17] 391938 0
Rating of Perceived Exertion
Training session intensity will be determined subjectively through sessional rating of perceived exertion (sRPE). sRPE will be obtained using the Category-Ratio scale (CR-10) at the completion of the exercise sessions in weeks 3 and 11.
Timepoint [17] 391938 0
Baseline (pre-program), 12 weeks post-intervention commencement (post-program)
Secondary outcome [18] 393520 0
Cardiorespiratory Fitness
To assess cardiorespiratory fitness, the Yo-Yo Intermittent Endurance (YYIE1) test will be undertaken among participants allocated exercise groups during the first session of week 1 and during a single testing session in week 13 of the study. The test will require participants to complete 2 x 20m shuttle runs, incrementally increasing in speed, interspersed with a 5s recovery period (2 x 2.5m). The test will be performed outdoors on a grass oval, succeeding a 10-minute warm-up. The test will be terminated once the participant fails to complete a shuttle in the allocated time or voluntarily discontinues the test due to exhaustion. Performance will be defined as the total distance covered during the test.
Timepoint [18] 393520 0
Baseline (pre-program), 12-weeks post-intervention commencement (post-program)

Eligibility
Key inclusion criteria
In order to be eligible to participate in the study participants must meet the following criteria:
- Male
- 35 - 54 years of age
- On average, engaging in less than 150 minutes of moderate-intensity exercise or less than 75 minutes of vigorous-intensity exercise per week over the 6 months leading up to the study
- Assessed as safe to engage in the exercise program based on the Exercise and Sports Science Australia Adult Pre-exercise Screening System
Minimum age
35 Years
Maximum age
54 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded to participate in the study if they meet any of the following criteria:
- Have a medical condition or injury that restricts them from performing exercise
- Have had a change in medication that might influence outcome measures within 3 months of study start
- Currently participating in a team sport
- Are unwilling or unable to provide written consent
- Show unwillingness to be randomised to either experimental group
- Fail to satisfy the investigator regarding suitability to participate for any other reason

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The first participant will be allocated to either of the exercise programs via coin flip. Subsequent participants will be randomised to the team-sport program or the group-circuit program by minimisation (Altman & Bland 2005). Minimisation will be employed using the participant's HRQoL composite scores, physical activity level, age, and body mass index at familiarisation to ensure the treatment groups are matched at baseline on these characteristics.
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
Sample size
The sample size required for this study has been calculated using a medium effect size of 0.5. 0.5 effect size is considered meaningful for HRQoL (Norman, Sloan & Wyrwich 2003). In order to detect a meaningful change in HRQoL, with an alpha level of 0.05 and 80% power, 128 participants are needed (64 per group). To account for the potential drop out of 10%, 140 participants will be recruited.

Data Analysis
All data will be presented as mean ± standard deviation. All data analysis will be performed using Stata/IC V.15 (StataCorp LLC, College Station, Texas, USA). Independent Samples t-tests will be used to compare participant characteristics at baseline. To assess the effects of the independent variable (SSG or CT) on the dependent variables (HRQoL, PA level, motivation, psychological needs and physical health and fitness), a linear mixed effect model (LMEM) will be used. Fixed effects will be entered as outcome measures, treatment allocation and time point, and participant ID entered as a random effect. If participants drop out, what available data will be included in analysis provided drop out occurred at random. Using all remaining available data in the random effect mixed model will constitute an intention-to-treat analysis. A sensitivity analysis will be performed following this using only complete participant data (those who complied with the entire protocol). If participant drop-out is deemed not to be random in nature, we will undertake a per-protocol analysis and we will only include participants who attend at least 70% of the structured training sessions and have all relevant data points available.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
17/03/2021
Date of last participant enrolment
Anticipated
28/02/2022
Actual
7/07/2021
Date of last data collection
Anticipated
6/09/2022
Actual
16/12/2021
Sample size
Target
140
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307144 0
Commercial sector/Industry
Name [1] 307144 0
Norwood Football Club
Country [1] 307144 0
Australia
Primary sponsor type
Individual
Name
Professor Jon Buckley
Address
University of South Australia, Allied Health and Human Performance; Alliance for Research in Exercise, Nutrition and Activity
108 North Terrace, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 307728 0
Individual
Name [1] 307728 0
Dr. Alyson Crozier
Address [1] 307728 0
University of South Australia, Allied Health and Human Performance; Alliance for Research in Exercise, Nutrition and Activity
108 North Terrace, Adelaide, South Australia, 5000
Country [1] 307728 0
Australia
Secondary sponsor category [2] 307730 0
Individual
Name [2] 307730 0
Dr. Brad Stenner
Address [2] 307730 0
University of South Australia, Allied Health and Human Performance; Alliance for Research in Exercise, Nutrition and Activity
108 North Terrace, Adelaide, South Australia, 5000
Country [2] 307730 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307257 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 307257 0
Ethics committee country [1] 307257 0
Australia
Date submitted for ethics approval [1] 307257 0
01/10/2020
Approval date [1] 307257 0
21/10/2020
Ethics approval number [1] 307257 0
203274

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

Contacts
Principal investigator
Name 106590 0
Mr Henry Blake
Address 106590 0
University of South Australia, City East campus, 108 North Terrace, Adelaide, SA 5001
Country 106590 0
Australia
Phone 106590 0
+61 8 830 21502
Fax 106590 0
Email 106590 0
[email protected]
Contact person for public queries
Name 106591 0
Henry Blake
Address 106591 0
University of South Australia, City East campus, 108 North Terrace, Adelaide, SA 5001
Country 106591 0
Australia
Phone 106591 0
+61 8 830 21502
Fax 106591 0
Email 106591 0
[email protected]
Contact person for scientific queries
Name 106592 0
Henry Blake
Address 106592 0
University of South Australia, City East campus, 108 North Terrace, Adelaide, SA 5001
Country 106592 0
Australia
Phone 106592 0
+61 8 830 21502
Fax 106592 0
Email 106592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be made public as the study is not publicly funded. The study was funded privately through industry and the IPD remains the intellectual property of the industry partner.


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
SourceTitleYear of PublicationDOI
EmbaseRandomised controlled trial comparing two group-based exercise programmes (team sport vs circuit training) on men's health: Study protocol.2021https://dx.doi.org/10.1136/bmjsem-2021-001140
N.B. These documents automatically identified may not have been verified by the study sponsor.