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Trial registered on ANZCTR


Registration number
ACTRN12619000608167p
Ethics application status
Submitted, not yet approved
Date submitted
9/04/2019
Date registered
23/04/2019
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
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.
Scientific title
Concurrent exercise training for physical and mental health in the academic workplace; bilateral significance for employer and employee.
Secondary ID [1] 297921 0
None
Universal Trial Number (UTN)
U1111-1231-4165
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 312304 0
Anxiety 312305 0
Type 2 Diabetes Mellitus 312306 0
Cardiovascular disease 312307 0
Condition category
Condition code
Cardiovascular 310866 310866 0 0
Normal development and function of the cardiovascular system
Inflammatory and Immune System 310867 310867 0 0
Normal development and function of the immune system
Mental Health 310868 310868 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 310869 310869 0 0
Normal metabolism and endocrine development and function
Mental Health 310933 310933 0 0
Depression
Mental Health 310934 310934 0 0
Anxiety
Metabolic and Endocrine 310935 310935 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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 16-weeks. Training will be conducted face to face in small groups (8-10 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 lunges, goblet squats, step ups and machine-based leg press and leg curl for the lower body, and machine-based chest press, shoulder press and cable pull down and cable row for the upper body.
- Endurance exercise conducted on treadmills, 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.
- The CR-10 rating of perceived exertion (RPE) scale (Borg 1982) to guide exercise load during training, and to provide an overall session RPE (sRPE) 5 min post session. RPE limits will be between 4-6 for endurance exercise, and will progress from 5-7 to 6-8 for resistance training.

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, whilst maintaining exertion levels within the given RPE limits.

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.
Intervention code [1] 314149 0
Lifestyle
Comparator / control treatment
The control group will maintain their normal lifestyle as determined using the International Physical Activity Questionnaire (Craig et al. 2003) and diet analysis (ASA24)
Control group
Active

Outcomes
Primary outcome [1] 319700 0
systemic inflammation (plasma tumor necrosis factor-alpha) as measured by serum assay.
Timepoint [1] 319700 0
Baseline and 16-weeks after intervention commencement
Primary outcome [2] 319701 0
Depression, anxiety and stress scores as measured by the Depression, Anxiety and Stress Scales-21 (DASS-21)
Timepoint [2] 319701 0
Baseline and 16-weeks after intervention commencement
Primary outcome [3] 319702 0
Presenteeism as measured by the work limitations questionnaire (WLQ)
Timepoint [3] 319702 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [1] 369219 0
Psychological distress as measured by the Kessler Psychological Distress Scale (K10)
Timepoint [1] 369219 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [2] 369220 0
Daily wellness score using a questionnaire that has been previously published, via MetricWire
Timepoint [2] 369220 0
Once per day for 14-days from baseline, and once per day for 14-days in weeks 15 and 16 of the intervention
Secondary outcome [3] 369221 0
Work load using a questionnaire designed for this study, via MetricWire
Timepoint [3] 369221 0
Once per day for 14-days from baseline, and once per day for 14-days in weeks 15 and 16 of the intervention
Secondary outcome [4] 369222 0
Quality adjusted life years as measured by the EuroQol 5 dimensions 5 level (EQ-5D-5L) instrument
Timepoint [4] 369222 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [5] 369223 0
Job stress as measured by the 16-item version of the effort reward imbalance (ERI) questionnaire
Timepoint [5] 369223 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [6] 369225 0
Absenteeism as measured by items from the Productivity Cost Questionnaire (iPCQ)
Timepoint [6] 369225 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [7] 369226 0
Blood pressure as measured by the ambulatory office blood pressure (AOBP) method
Timepoint [7] 369226 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [8] 369228 0
Body composition (whole-body fat mass, lean mass and bone mineral content) as measured by Dual Energy X-ray Absorptiometry (DEXA)
Timepoint [8] 369228 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [9] 369229 0
Body mass index as measured via electronic scales (weight) and stadiometer (height)
Timepoint [9] 369229 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [10] 369230 0
Waist circumference via anthropometric tape
Timepoint [10] 369230 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [11] 369231 0
Fasting glucose via serum assay
Timepoint [11] 369231 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [12] 369232 0
Triglycerides via serum assay
Timepoint [12] 369232 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [13] 369233 0
High-density lipoprotein (HDL) via serum assay
Timepoint [13] 369233 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [14] 369234 0
Hemoglobin A1c (HbA1c) via serum assay
Timepoint [14] 369234 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [15] 369235 0
Cardiorespiratory fitness via graded exercise test and metabolic cart
Timepoint [15] 369235 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [16] 369236 0
Physical activity via accelerometer
Timepoint [16] 369236 0
Every day for 14-days from baseline, and every day for 14-days in weeks 15 and 16 of the intervention
Secondary outcome [17] 369237 0
Diet composition via automated self-administered 24 h Recall (ASA24)
Timepoint [17] 369237 0
Once per day for 14-days from baseline, and once per day for 14-days in weeks 15 and 16 of the intervention
Secondary outcome [18] 369553 0
Sedentary behaviour via accelerometer
Timepoint [18] 369553 0
Every day for 14-days from baseline, and every day for 14-days in weeks 15 and 16 of the intervention
Secondary outcome [19] 369554 0
sleep behaviour via accelerometer
Timepoint [19] 369554 0
Every day for 14-days from baseline, and every day for 14-days in weeks 15 and 16 of the intervention
Secondary outcome [20] 369555 0
Physical activity via International Physical Activity Questionnaire (IPAQ)
Timepoint [20] 369555 0
Baseline and 16-weeks after intervention commencement
Secondary outcome [21] 369556 0
Sleep behaviour via sleep diary
Timepoint [21] 369556 0
Every day for 14-days from baseline, and every day for 14-days in weeks 15 and 16 of the intervention
Secondary outcome [22] 369557 0
systemic inflammation (plasma interleukin-6) as measured by serum assay.
Timepoint [22] 369557 0
Baseline and 16-weeks after intervention commencement

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 40 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.
Minimum age
40 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Pregnancy
2) Previous diagnoses of metabolic disease or severe musculoskeletal disorders
3) Anti-inflammatory and/or pharmacological treatment
4) Contraindications to exercise as identified in the health pre-screening.

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)
Allocation sequence will be concealed from the researcher by using sequentially numbered, opaque, sealed and stapled envelopes, produced by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be stratified (VO2peak, age, gender), placed into random blocks and randomized (computerized random number generator)
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 3.1.9.3) (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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 26244 0
2007 - Ultimo

Funding & Sponsors
Funding source category [1] 302437 0
University
Name [1] 302437 0
University of Technology Sydney
Address [1] 302437 0
15 Broadway, Ultimo NSW 2007
Country [1] 302437 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 302339 0
None
Name [1] 302339 0
Address [1] 302339 0
Country [1] 302339 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303106 0
UTS Human Research Ethics Committee (HREC)
Ethics committee address [1] 303106 0
15 Broadway, Ultimo NSW 2007
Ethics committee country [1] 303106 0
Australia
Date submitted for ethics approval [1] 303106 0
04/04/2019
Approval date [1] 303106 0
Ethics approval number [1] 303106 0

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 4-month CT intervention on the mental and physical health of full-time academics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92494 0
Prof Rob Duffield
Address 92494 0
University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
Country 92494 0
Australia
Phone 92494 0
+61 2 9514 5023
Fax 92494 0
Email 92494 0
Rob.Duffield@uts.edu.au
Contact person for public queries
Name 92495 0
Prof Rob Duffield
Address 92495 0
University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
Country 92495 0
Australia
Phone 92495 0
+61 2 9514 5023
Fax 92495 0
Email 92495 0
Rob.Duffield@uts.edu.au
Contact person for scientific queries
Name 92496 0
Prof Rob Duffield
Address 92496 0
University of Technology Sydney, Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
Country 92496 0
Australia
Phone 92496 0
+61 2 9514 5023
Fax 92496 0
Email 92496 0
Rob.Duffield@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
What supporting documents are/will be available?
No other documents available
Summary results
No Results