Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000404527
Ethics application status
Approved
Date submitted
13/04/2015
Date registered
30/04/2015
Date last updated
30/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise for Mental Health in Medical Students: The UNSW MedEx Project
Scientific title
Effect of structured exercise on psychological distress among undergraduate medical students
Secondary ID [1] 286518 0
Nil
Universal Trial Number (UTN)
Trial acronym
MedEx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 294737 0
Mental health 294738 0
Condition category
Condition code
Mental Health 295024 295024 0 0
Depression
Mental Health 295085 295085 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Supervised high intensity aerobic interval training
participants randomized to the aerobic interval group will attend the CSEP labs 2 x per week for 15 minutes for 8 weeks. Participants in this group will complete an aerobic training session on the stationary bike incorporating 5 x 1 minute maximum effort (rate of perceived exertion 15- 18/20) cycling bouts, with one minute active low intensity (RPE 8-9) recovery between each bout. Each session will be preceded by a warm up and followed by a cool down. Sessions will be supervised an Accredited Exercise Physiologist (AEP). Sessions will be one-on-one.

Arm 2: Progressive resistance training (PRT)
Participants randomised to the PRT group will attend the university training laboratory located on Ground Floor of the Wallace Wurth Building, University of NSW. Participants will exercise 2 times per week for approximately 15 minutes each visit for 8 weeks. Training will be fully supervised by an AEP to maintain proper intensity and progression, as well as to ensure correct technique. All PRT participants will receive weight lifting exercises of 5 major muscle groups using resistance equipment located in the CSEP lab. Exercises chosen include the large muscle groups of the chest, upper back and upper leg and include the cable chest press, standing cable row and leg press. These are symmetrical exercises and functionally relevant to activities of daily living (ADLs). Participants will perform 3 sets of 8 repetitions of each exercise, with controlled concentric and eccentric phases. The initial intensity for this treatment group will be set at 50% of the participant’s peak strength determined at baseline (1 repetition maximum or 1RM). Intensity will then be increased by 10% each session over 4 sessions until 80% 1RM has been reached, as we have done in previous trials of adults. Repetition maximum testing will be repeated at 2-week intervals to ascertain progress and intensity will be adjusted accordingly (usually ˜3% per session) and fine-tuned by a rating of between 15-18 on the BORG Rating of Perceived Exertion Scale. This will ensure maintenance of an intensity of 80% of the subject’s current 1RM on a continuous basis throughout the 8 week training program. Sessions will be one-on-one.

Arm 3: Active control
Participants who are randomised to the active control will be given the current National Physical Activity guidelines of completing 10,000 steps per day. Steps will be measured by a Jawbone or similar physical activity device and recorded/synced at a twice weekly visit with an AEP located in the Clinical Skills Exercise Physiology (CSEP) Lab. This will ensure equal contact exposure to the supervised intervention groups. Face-to-face contact will be one-on-one.
Intervention code [1] 291611 0
Lifestyle
Intervention code [2] 291667 0
Prevention
Comparator / control treatment
Participants who are randomised to the active control will be given the current National Physical Activity guidelines of completing 10,000 steps per day. Steps will be measured by a Jawbone or similar physical activity device and recorded/synced at a twice weekly visit with an AEP located in the Clinical Skills Exercise Physiology (CSEP) Lab. This will ensure equal contact exposure to the supervised intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 294782 0
Psychological distress (Kessler-10)
Timepoint [1] 294782 0
Baseline and 8-weeks post
Secondary outcome [1] 314031 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 314031 0
Baseline and 8-weeks post
Secondary outcome [2] 314032 0
Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [2] 314032 0
Baseline and 8-weeks post
Secondary outcome [3] 314033 0
Active Australia Physical Activity Questionnaire
Timepoint [3] 314033 0
Baseline and 8-weeks post
Secondary outcome [4] 314034 0
Weight (kg)
Timepoint [4] 314034 0
Baseline and 8-weeks post
Secondary outcome [5] 314035 0
Waist circumference (cm)
Timepoint [5] 314035 0
Baseline and 8-weeks post
Secondary outcome [6] 314036 0
Blood pressure
Timepoint [6] 314036 0
Baseline and 8-weeks post
Secondary outcome [7] 314037 0
Maximum muscle strength (repetition maximum assessment)
Timepoint [7] 314037 0
Baseline and 8-weeks post
Secondary outcome [8] 314038 0
Peak aerobic capacity ( Volume Oxygen consumption)
Timepoint [8] 314038 0
Baseline and 8-weeks post
Secondary outcome [9] 314039 0
Resting heart rate (Electrocardiograph)
Timepoint [9] 314039 0
Baseline and 8-weeks post

Eligibility
Key inclusion criteria
Participants must be ambulatory
Participants must be willing to provide written informed consent Participants must be willing to participate in the study and comply with the study requirements over 10 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with current alcohol or substance abuse; Persons unable to comply with study requirements over the course of 10 weeks (including baseline and final assessments); Persons currently undertaking a resistance training or other regular (at least 3 days per week) moderate to high intensity exercise of any kind; Persons with specific contraindications to resistance or high intensity aerobic training exercise such as unstable cardiovascular disease, aortic aneurysm, symptomatic hernias, proliferative diabetic retinopathy, retinal laser surgery within 6 weeks, uncontrolled hypertension or rapidly progressive or terminal illness; Persons on psychotropic drugs or currently undertaking psychological interventions to control stress, anxiety and/or depression.

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)
The study will be advertised via advertisements located in and around the Wallace Wurth and Biomedical building on the UNSW Kensington campus, as well as via announcements to students at the end of lectures and via word of mouth from medical students at UNSW. The MedEx Project advertisements will be displayed around the UNSW Faculty of Medicine buildings as a poster, and promoted by the President of the UNSW Medical Society. Advertisements will invite students to participate and be sure to let students know that participation is entirely voluntary and their relationship with the University and Academic staff will not be affected in anyway should they choose not to participate. If students are interested in taking part in the study, they will be asked to contact Dr Belinda Parmenter via email: [email protected]. The student will be asked to provide their contact details to a researcher who will then contact them to discuss the study, perform an initial telephone screen (script attached) and arrange a time for the initial assessment. Upon completing the telephone screen and showing initial eligibility, participants will be emailed a Participant Information Statement and Informed Consent (attached) which will outline the study in detail. Participants will be asked to read through this and to bring it along with them to their initial appointment to have any questions they may have answered and to sign consent prior to providing any further information, including completing the MedEx screening tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by an independent researcher via a computer-generated randomisation scheme using randomly permuted blocks (www.randomization.com) after completion of baseline testing. Stratification by gender will be planned, due to the likely gender imbalance favouring men and their physiological adaptations to exercise training. Allocation will be concealed via placement of sequential group assignments into opaque sealed envelopes prepared by an independent researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All key outcomes will be measured at baseline and 9 weeks, after completion of 8 week exercise program. Data will be entered into a password secure SPSS software database (PASW Statistics 20, IBM Corporation, Armonk, NY, USA) on the UNSW Exercise Physiology server. Data will be analysed via ‘intention to treat’ with missing follow up data imputed via the expectation maximization algorithm. Data will be inspected for normality visually and statistically (skewness -1 to greater than or equal to 1) and expressed as mean and standard deviation. Baseline comparisons between the three groups will be made via analysis of variance (ANOVA) or chi square test as appropriate. Relationships between stress and physical activity levels in each group will be determined by simple, stepwise and multiple linear regression models as appropriate. Differences in outcomes between groups will be analysed by repeated analysis of variance models, adjusting for relevant covariates with group by time interaction as the primary outcome of interest. Covariates will be chosen as appropriate via a priori hypothesised confounders as well as observed differences between groups at baseline within the cohort. Relationships between variables of interest at baseline and between change scores will be determined by simple and stepwise regression models. Statistical significance will be initially set at 0.05. Relative effect size and 95% CIs will be calculated for all outcomes.
Sample size calculations were based on a 2010 Cochrane review on Exercise for Depression, where exercise produced a moderate improvement in symptoms of depression post treatment (effect size -0.67 [-0.90 to -0.43]). Setting alpha at 0.05, and beta at 0.2, gives the study an actual power of 80% to detect a significant moderate (ES=-0.67) improvement in symptoms of depression using the Kessler-10 Scale of Psychological Distress. Setting n1=n2=n3, a sample size of n=108 (36 per group) was therefore calculated. If we then conservatively estimate a drop out of 10%, a sample size of approximately 120 participants (40 per group) will be needed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/04/2015
Actual
6/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291083 0
Self funded/Unfunded
Name [1] 291083 0
Country [1] 291083 0
Primary sponsor type
University
Name
University of New South Wales
Address
Department of Exercise Physiology
School of Medical Sciences
Faculty of Medicine
Wallace Wurth Building
University of New South Wales
New South Wales
Sydney 2052
Country
Australia
Secondary sponsor category [1] 289760 0
None
Name [1] 289760 0
Address [1] 289760 0
Country [1] 289760 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 56458 0
Dr Belinda Parmenter
Address 56458 0
Department of Exercise Physiology
School of Medical Sciences
Faculty of Medicine
Wallace Wurth Building
University of New South Wales
Sydney 2052
Country 56458 0
Australia
Phone 56458 0
+61 2 9385 8313
Fax 56458 0
Email 56458 0
[email protected]
Contact person for public queries
Name 56459 0
Simon Rosenbaum
Address 56459 0
The Bondi Centre, South Eastern Sydney Local Health District
26 Llandaff St
Bondi Junction
NSW 2022
Country 56459 0
Australia
Phone 56459 0
+61 2 9366 8669
Fax 56459 0
Email 56459 0
[email protected]
Contact person for scientific queries
Name 56460 0
Simon Rosenbaum
Address 56460 0
The Bondi Centre, South Eastern Sydney Local Health District
26 Llandaff St
Bondi Junction
NSW 2022
Country 56460 0
Australia
Phone 56460 0
+61 2 9366 8669
Fax 56460 0
Email 56460 0
[email protected]

No information has been provided regarding IPD availability


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.