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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000608167
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
23/04/2019
Date last updated
12/11/2021
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
12/11/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Combined endurance and resistance exercise training for physical and mental health in the academic workplace; significance for both employer and employee.
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Scientific title
Concurrent exercise training for physical and mental health in the academic workplace; bilateral significance for employer and employee.
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Secondary ID [1]
297921
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None
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Universal Trial Number (UTN)
U1111-1231-4165
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
312304
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Anxiety
312305
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Type 2 Diabetes Mellitus
312306
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Cardiovascular disease
312307
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Condition category
Condition code
Cardiovascular
310866
310866
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0
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Normal development and function of the cardiovascular system
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Inflammatory and Immune System
310867
310867
0
0
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Normal development and function of the immune system
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Mental Health
310868
310868
0
0
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Studies of normal psychology, cognitive function and behaviour
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Metabolic and Endocrine
310869
310869
0
0
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Normal metabolism and endocrine development and function
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Mental Health
310933
310933
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0
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Depression
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Mental Health
310934
310934
0
0
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Anxiety
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Metabolic and Endocrine
310935
310935
0
0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Brief name: Concurrent exercise training (CT) for physical and mental health in the academic workplace.
Why:
Full-time desk-based workers may be at greater risk of common mental disorders (CMD) and metabolic syndrome due to low levels of physical activity, or chronic stress. Considering the bidirectional relationship between physical activity and stress, it is clear that increasing physical activity through a concurrent resistance and endurance exercise training intervention (CT) could provide significant mental and physical health benefits to employees within the workplace. The academic workplace is unique in that academics have higher psychological strain and lower job satisfaction compared to other university staff, who already present with greater anxiety and depression than the general population. Considering the paucity of health research within academia, this high-risk cohort lends itself to an investigation of the impact of CT on mental and physical health within the workplace.
What, how and where and when:
The CT intervention will involve both endurance and resistance training. Participants in the CT group will train for 1 h, three times per week, for 14-weeks. Training will be conducted face to face in small groups (2-6 participants) within climate-controlled exercise facilities at either the UTS city or Moore Park campus’.
Training sessions will involve:
- A 5 min warm-up circuit at 50% working weight, and dynamic stretching, followed by resistance and endurance training.
- Resistance exercises including split squats, hip thrusts and machine-based leg press and leg curl for the lower body, and machine-based chest press, horizontal row and lat pull down for the upper body.
- Endurance exercise conducted on cycling and rowing ergometers, with equal duration spent in each endurance exercise modality.
- Static stretching of the primary muscle groups at the conclusion of each session.
- Resistance training gradually progressed to involve 3 sets of 8-12 repetitions, and load was increased once a participant could complete the required number of repetitions with proper technique on all sets over two consecutive training sessions. Following resistance exercise, endurance exercise will be performed for 15-22min.
- Rest periods and repetition velocity were self-determined with consultation from training instructors.
The first week of training will educate participants on proper form when completing each respective exercise and familiarise subjects with the RPE scale. 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.
Who provided:
Training sessions will be designed by accredited exercise scientists and supervised by trained instructors (third year 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 manage these sessions independently.
How well:
Adherence to the intervention will be objectively measured via attendance sheets by the supervisor at each training session
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Intervention code [1]
314149
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Lifestyle
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Comparator / control treatment
The control group will maintain their normal lifestyle as determined by the Godin Exercise Leisure Time Questionnaire (Godin 1997) and diet analysis (ASA24)
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Control group
Active
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Outcomes
Primary outcome [1]
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systemic inflammation (plasma tumor necrosis factor-alpha) as measured by serum assay.
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Assessment method [1]
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Timepoint [1]
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Baseline and 14-weeks after intervention commencement
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Primary outcome [2]
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Depression, anxiety and stress scores as measured by the Depression, Anxiety and Stress Scales-21 (DASS-21)
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Assessment method [2]
319701
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Timepoint [2]
319701
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Baseline and 14-weeks after intervention commencement
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Primary outcome [3]
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Presenteeism as measured by the work limitations questionnaire (WLQ)
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Assessment method [3]
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Timepoint [3]
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [1]
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Psychological distress as measured by the Kessler Psychological Distress Scale (K10)
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Assessment method [1]
369219
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Timepoint [1]
369219
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [2]
369220
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Daily wellness score using a questionnaire that has been previously published, via MetricWire
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Assessment method [2]
369220
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Timepoint [2]
369220
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Once per day for 14-days from baseline, and once per day for 14-days in weeks 13 and 14 of the intervention
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Secondary outcome [3]
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Work load using a questionnaire designed for this study, via MetricWire
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Assessment method [3]
369221
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Timepoint [3]
369221
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Once per day for 14-days from baseline, and once per day for 14-days in weeks 13 and 14 of the intervention
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Secondary outcome [4]
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Quality adjusted life years as measured by the EuroQol 5 dimensions 5 level (EQ-5D-5L) instrument
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Assessment method [4]
369222
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Timepoint [4]
369222
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [5]
369223
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Job stress as measured by the 16-item version of the effort reward imbalance (ERI) questionnaire
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Assessment method [5]
369223
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Timepoint [5]
369223
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [6]
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Absenteeism as measured by items from the Productivity Cost Questionnaire (iPCQ)
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Assessment method [6]
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Timepoint [6]
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [7]
369226
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Blood pressure as measured by the ambulatory office blood pressure (AOBP) method
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Assessment method [7]
369226
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Timepoint [7]
369226
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [8]
369228
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Body composition (whole-body fat mass, lean mass and bone mineral content) as measured by Dual Energy X-ray Absorptiometry (DEXA)
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Assessment method [8]
369228
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Timepoint [8]
369228
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [9]
369229
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Body mass index as measured via electronic scales (weight) and stadiometer (height)
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Assessment method [9]
369229
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Timepoint [9]
369229
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [10]
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Waist circumference via anthropometric tape
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Assessment method [10]
369230
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Timepoint [10]
369230
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [11]
369231
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Fasting glucose via serum assay
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Assessment method [11]
369231
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Timepoint [11]
369231
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [12]
369232
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Triglycerides via serum assay
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Assessment method [12]
369232
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Timepoint [12]
369232
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [13]
369233
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High-density lipoprotein (HDL) via serum assay
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Assessment method [13]
369233
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Timepoint [13]
369233
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [14]
369235
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Cardiorespiratory fitness via graded exercise test and metabolic cart
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Assessment method [14]
369235
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Timepoint [14]
369235
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Baseline and 14-weeks after intervention commencement
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Secondary outcome [15]
369237
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Diet composition via automated self-administered 24 h Recall (ASA24)
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Assessment method [15]
369237
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Timepoint [15]
369237
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Once per day for 14-days from baseline, and once per day for 14-days in weeks 13 and 14 of the intervention
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Secondary outcome [16]
369556
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Sleep behaviour via sleep diary
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Assessment method [16]
369556
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Timepoint [16]
369556
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Once per day for 14-days from baseline, and once per day for 14-days in weeks 13 and 14 of the intervention
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Secondary outcome [17]
369557
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systemic inflammation (plasma interleukin-6) as measured by serum assay.
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Assessment method [17]
369557
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Timepoint [17]
369557
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Update Baseline and 14-weeks after intervention commencement
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Eligibility
Key inclusion criteria
1) “Insufficiently active” according to the Active Australia criteria (<150 min/wk of weighted physical activity, where vigorous activity minutes are doubled)
2) Middle-aged (between 35 and 65 years)
3) Working a minimum of 35 h per week at the university as an academic
4) Willingness to give written informed consent and willingness to participate to and comply with the study.
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Minimum age
35
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1) Pregnancy
2) Previous diagnoses of metabolic disease or severe musculoskeletal disorders
3) Pharmacological treatment for depression, diabetes, cardiovascular disease, or inflammation
4) Contraindications to exercise as identified in the health pre-screening.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent third party generated a series of random numbers via a computerized random number generator and another third party allocated matched participant codes using a 1:1 ratio into either a concurrent training (CT), or control group (CONT), according to the random number sequence.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were stratified (age, gender, VO2peak,), matched to the nearest neighbour and randomized (computerized random number generator).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A priori sample size calculation was performed using G*Power software (Version 3.1.9.3) (Faul et al. 2007). Based on previously published data, it was determined that a sample size of 90 participants would be necessary to detect small to medium effect sizes within dependent variables. Sample size calculation was performed with an effect size f of 0.15, alpha error of 0.05, and a power of 0.80. To maximise power and account for drop-out, one hundred and fifty participants will be recruited
A complete case analysis will be conducted. A 2-way repeated measures ANOVA will be used to detect any differences between or within groups (CT and control) for the dependent variables. Smokers will be analysed as a subset group. Additionally, multiple linear regression models will be developed for mental and physical health measures to determine relationships between variables.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
31/05/2019
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Actual
8/08/2019
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Date of last participant enrolment
Anticipated
31/05/2019
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Actual
8/08/2019
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Date of last data collection
Anticipated
31/10/2019
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Actual
16/12/2019
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Sample size
Target
150
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
26244
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2007 - Ultimo
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Technology Sydney
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Address [1]
302437
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15 Broadway, Ultimo NSW 2007
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Country [1]
302437
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Australia
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Primary sponsor type
University
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Name
University of Technology Sydney
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Address
15 Broadway, Ultimo NSW 2007
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
302339
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Address [1]
302339
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Country [1]
302339
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303106
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UTS Human Research Ethics Committee (HREC)
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Ethics committee address [1]
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15 Broadway, Ultimo NSW 2007
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
303106
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04/04/2019
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Approval date [1]
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08/05/2019
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Ethics approval number [1]
303106
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ETH18-3093
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Summary
Brief summary
Full-time desk-based workers may be at greater risk of mental (e.g. depression and anxiety) and physical (e.g. diabetes and cardiovascular disease) disease due to low levels of physical activity and/or chronic stress. There is preliminary evidence that increasing physical activity through a combined resistance and endurance exercise training intervention (CT) could provide significant mental and physical health benefits to employees within this workplace. The academic workplace is unique in that academics have higher psychological strain and lower job satisfaction compared to other university staff, who already present with greater symptoms of anxiety and depression than the general population. Considering the paucity of health research within academia, this high-risk cohort lends itself to an investigation of the impact of CT on mental and physical health within the workplace. In turn, this study will determine the effects of a 14-week CT intervention on the mental and physical health of inactive full-time academics.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Rob Duffield
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Address
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University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
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Country
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Australia
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Phone
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+61 2 9514 5023
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Fax
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Email
92494
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[email protected]
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Contact person for public queries
Name
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Prof Rob Duffield
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Address
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University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
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Country
92495
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Australia
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Phone
92495
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+61 2 9514 5023
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Fax
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Email
92495
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[email protected]
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Contact person for scientific queries
Name
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Prof Rob Duffield
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Address
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University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
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Country
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Australia
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Phone
92496
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+61 2 9514 5023
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Fax
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Email
92496
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results only, after de-identification
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When will data be available (start and end dates)?
Immediately following publication, no end date
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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
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Available for what types of analyses?
meta-analysis
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How or where can data be obtained?
Access subject to approvals by Principal Investigator
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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
Source
Title
Year of Publication
DOI
Embase
Effects of concurrent exercise training on body composition, systemic inflammation, and components of metabolic syndrome in inactive academics: a randomised controlled trial.
2023
https://dx.doi.org/10.1007/s00421-022-05108-w
N.B. These documents automatically identified may not have been verified by the study sponsor.
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