Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000097640
Ethics application status
Approved
Date submitted
21/01/2014
Date registered
28/01/2014
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise preference in overweight adults with clinical depression: a pilot study
Scientific title
A randomised controlled trial investigating the suitability of three formats of exercise intervention for overweight or obese adults with clinical depression.
Secondary ID [1] 283916 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical Depression 290913 0
Overweight/Obesity 290914 0
Condition category
Condition code
Mental Health 291266 291266 0 0
Depression
Diet and Nutrition 291267 291267 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All exercise interventions will be conducted 3x per week over 6 weeks, with approximately 45-60mins of exercise per session, including warm up and cool down. All exercise is supervised and conducted in individual format. Intensity is calculated via an initial VO2max test.



Arm 1 - Moderate Intensity Steady State Exercise - Participant performs steady state stationary cycling at a moderate intensity (60-65% VO2peak).

Arm 2 - High Intensity Interval Training - Participant performs repeated short bouts of high intensity exercise (e.g. 1min @ 95-100% VO2peak) followed by lower intensity recovery exercise (e.g. 4mins @ 40-45% VO2peak) on a stationary cycle.
Intervention code [1] 288598 0
Treatment: Other
Intervention code [2] 288661 0
Lifestyle
Intervention code [3] 288662 0
Behaviour
Comparator / control treatment
All exercise interventions will be conducted 3x per week over 6 weeks, with approximately 45-60mins of exercise per session, including warm up and cool down. All exercise is supervised and conducted in individual format.

Moderate Intensity Personal Preference Exercise - Participant chooses from either treadmill running, stationary cycling, stationary rowing or resistance training conducted at a moderate intensity (60-65%VO2max or 60-65% 1RM).
Control group
Active

Outcomes
Primary outcome [1] 291268 0
Primary outcome 1. Subjective enjoyment of exercise (visual analogue scale)
Timepoint [1] 291268 0
Measured 1x weekly for 6 week intervention
Primary outcome [2] 291269 0
Primary outcome 2. Subjective motivation to continue with exercise (visual analogue scale)
Timepoint [2] 291269 0
Measured 1x weekly for 6 week intervention
Primary outcome [3] 291270 0
Primary outcome 3. Subjective discomfort/fatigue from exercise (visual analogue scale)
Timepoint [3] 291270 0
Measured 1x weekly for 6 week intervention
Secondary outcome [1] 306382 0
% change in Beck Depression Inventory - II Scores
Timepoint [1] 306382 0
Measured at week 0, 4 and 7 (i.e. after the 6 week intervention)
Secondary outcome [2] 306384 0
% change in body fat (DEXA scan)
Timepoint [2] 306384 0
Week 0 and week 7 (pre-post intervention)

Eligibility
Key inclusion criteria
1. DSM-IV-TR Diagnosis of depression
2. Overweight or Obese (BMI: >25)
3. Not have diagnosed diabetes
4. Willing and able to participate in exercise intervention
5. Older than 18 years of age, younger than 45 years of age (if attending an Australian Tertiary Institution, older than 17 years of age)
6. Stable use of antidepressents (at least 3 weeks on regular dose)
7. No current engagement in therapy and willingness to postpone new therapy for the duration of participation
8. If female, must not be pregnant or attempting to become pregnant.
9. Understand written and spoken English (a conversational level of english is all that is required)
Minimum age
17 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Certain Mental disorders (Psychosis, Personality Disorder or other Mood Disorders - either ICD-10 or DSM-IV-TR)
2. Previous cardiovascular incident (e.g. heart attack, stroke)
3. Current cardiovascular disease (i.e. CHD)
4. Serious or unstable medical conditions (other than obesity)
5. Substance dependence requiring rehabilitation/detoxification
6. Current suicidal ideation or recent attempt (previous 24months)

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)
Allocation concealment will be conducted using investigators blind to enrolment/allocation procedures. i.e. Participants will be de-identified upon enrolment (screened by an investigator blind to the study interventions). A new investigator will randomly assign the de-identified participant to an intervention group via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of three groups using a computerised 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
Safety/efficacy
Statistical methods / analysis
Power analysis was conducted assuming alpha level of 0.05 and a moderate effect size (demonstrated in similar previous research).

Data will be analysed using 3x2 ANOVA and 3x3 Repeated Measures ANOVA.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/02/2014
Actual
1/05/2014
Date of last participant enrolment
Anticipated
30/06/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288557 0
University
Name [1] 288557 0
Murdoch University
Country [1] 288557 0
Australia
Funding source category [2] 288582 0
Charities/Societies/Foundations
Name [2] 288582 0
McCusker Charitable Foundation
Country [2] 288582 0
Australia
Primary sponsor type
Individual
Name
Nick Buckley
Address
Room 2-049 Social Sciences Building
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156 WA
Country
Australia
Secondary sponsor category [1] 287269 0
Individual
Name [1] 287269 0
Dr Helen Correia
Address [1] 287269 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156, WA
Country [1] 287269 0
Australia
Secondary sponsor category [2] 287270 0
Individual
Name [2] 287270 0
Dr Timothy Fairchild
Address [2] 287270 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch 6156, WA
Country [2] 287270 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290420 0
Human Research Ethics Committee - Research Ethics Office
Ethics committee address [1] 290420 0
Chancellery Building,
90 South St,
Murdoch University,
Murdoch, 6156 WA
Ethics committee country [1] 290420 0
Australia
Date submitted for ethics approval [1] 290420 0
Approval date [1] 290420 0
08/11/2013
Ethics approval number [1] 290420 0
2013/204

Summary
Brief summary
The propsed study will investigate the suitablity (particularly enjoyment, motivation to continue) of three formats of exercise intervention (Moderate Intensity Personal Preference; Moderate Intensity Steady State; and High Intensity Interval Training) for overweight or obese individuals with clinical depression. In essence, the proposed research will act as a feasibility/pilot study for a later study, which will be based on the results of the proposed research. In this future study a 12 week exercise program will be implemented (based on the proposed study outcomes) which will be compared to and used alongside a “gold standard” treatment of Cognitive Behaviour Therapy for depression. It is important to understand exercise preferences and motivation to continue exercise in this population prior to designing this treatment protocol. We expect that the format of exercise (high intensity vs moderate intensity; interval vs steady state vs personal preference) will differentially affect motivation and enjoyment as well as markers of inflammation, appetite, symptoms of depression and sleep quality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45590 0
Mr Nick Buckley
Address 45590 0
SS 2-049 School of Psychology & Exercise Science Murdoch University 90 South St, Murdoch, 6156 WA
Country 45590 0
Australia
Phone 45590 0
+61 423 611 365
Fax 45590 0
Email 45590 0
[email protected]
Contact person for public queries
Name 45591 0
Timothy Fairchild
Address 45591 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156 WA
Country 45591 0
Australia
Phone 45591 0
+61 08 9360 2959
Fax 45591 0
Email 45591 0
[email protected]
Contact person for scientific queries
Name 45592 0
Timothy Fairchild
Address 45592 0
School of Psychology & Exercise Science
Murdoch University
90 South St, Murdoch, 6156 WA
Country 45592 0
Australia
Phone 45592 0
+61 08 9360 2959
Fax 45592 0
Email 45592 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

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