Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000150246
Ethics application status
Approved
Date submitted
30/01/2009
Date registered
16/03/2009
Date last updated
3/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting physical activity to improve the outcome of depression in later life (ACTIVEDEP)
Scientific title
Randomised trial of a home-based physical activity programme versus usual general practice care for the treatment of depression in adults aged 50 years and older
Secondary ID [1] 252596 0
Nil
Universal Trial Number (UTN)
Trial acronym
ACTIVEDEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive disorder in adults aged 50 years and older 4254 0
Condition category
Condition code
Mental Health 4476 4476 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resistance exercise at home 3 times per week (3 sets of 10-15 reps for each major muscle group) and 150 minutes of aerobic exercise a week (eg, swimming, cycling, walking, or exercise step), usually 30 minutes per day over 5 days during the 12-week treatment phase.
Intervention code [1] 3976 0
Lifestyle
Comparator / control treatment
General Practitioners (GPs) in the control group will continue to treat patients with depression to the best of their knowledge and capacity. This will include, but not be limited to, use of antidepressants and counseling. We will be asking GPs in the control group to review their patients at the same frequency as the intervention group: baseline, 2, 4, 8 and 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 5355 0
50% reduction in the scores of the Montgomery-Asberg Depression Rating Scale (MADRS)
Timepoint [1] 5355 0
12, 26 and 52 weeks from the start of treatment.
Primary outcome [2] 5356 0
Remission of symptoms (no longer meeting criteria for depressive episode), as established by a formal diagnostic telephone interview using the module for current major depressive disorder from the Structured Clinical Interview for DSM-IV-TR Research Version (SCID), between baseline and week 12 of the intervention.
Timepoint [2] 5356 0
12, 26 and 52 weeks from the start of treatment
Secondary outcome [1] 9005 0
Change in participants' level of physical activity as measured by the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire
Timepoint [1] 9005 0
12, 26 and 52 weeks from the start of treatment
Secondary outcome [2] 9006 0
Change in physiological measures - Functional Reach Test, Timed Chair Stand, Timed Up and Go, Cardiorespiratory Capacity
Timepoint [2] 9006 0
12, 26 and 52 weeks from the start of treatment

Eligibility
Key inclusion criteria
- age 50 years or over, of either sex
- meet Diagnostic and Statistical Manual of Mental Disorders (4th Edition) (DSM-IV) criteria for the diagnosis of major depressive episode within the context of a depressive disorder
- fluent in written and spoken English
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Do not fulfill DSM-IV criteria for a depressive episode, - considered at risk of suicide, - report delusions or hallucinations, - not fluent in written or spoken English, - are not community dwelling, - evidence of concurrent alcohol or substance abuse or dependency (Alcohol Use Disorders Identification Test - AUDIT = 7), - have difficulty with locomotion, - a medical condition that may preclude participation in a physical activity program, - do not wish to engage in a program of physical activity for a total period of 12 weeks, - no written informed consent.

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)
A project information and screening questionnaire pack will be posted to a random electoral sample of community-dwelling individuals aged 50 years and older residing in the Perth-metropolitan region. Those meeting criteria for a depressive illness will be invited to participate in the study and a medical consultation will be arranged with their GP to initiate treatment - allocation to either usual medical care (control) or medical care and physical activity (intervention) will be based on the randomisation of older people with depression by an independent researcher not involved with the study - research staff in contact with participants will be blind to the computerised central randomisation of participants' allocated treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used to allocate participants to the intervention (health promotion program of physical activity) or control group (usual care) by an independent academic. Blocks will vary in size from 4 to 10 participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/04/2009
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
19/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4433 0
Government body
Name [1] 4433 0
Healthway
Country [1] 4433 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 3994 0
University
Name [1] 3994 0
Edith Cowan University
Address [1] 3994 0
270 Joondalup Drive
Joondalup WA 6027
Country [1] 3994 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6485 0
Human Research Ethics Committee - University of Western Australia
Ethics committee address [1] 6485 0
35 Stirling Highway
Crawley WA 6009
Ethics committee country [1] 6485 0
Australia
Date submitted for ethics approval [1] 6485 0
Approval date [1] 6485 0
15/12/2008
Ethics approval number [1] 6485 0
RA/4/1/2233

Summary
Brief summary
Depression is a leading cause of disability worldwide and affects 5-15% of adults over the age of 65 years. Several currently available treatments for depression have proven efficacy, but up to 40% of people with depression fail to recover after a course of appropriate treatment. This, in turn, leads to increased long term morbidity and mortality, greater use of health services, and increased costs to the person with depression, his or her family and the community. Various sources of observational data and a few trials indicate that physical activity improves mood and promotes the remission of symptoms in older people with depression. We designed the present study to determine if a general practitioner mediated physical activity intervention for older adults with depression improves treatment response to usual antidepressant treatment and decreases the prevalence of depression over a 1-year period. The intervention has been designed for delivery to a large number of older people by being inexpensive, home based, and delivered via easily distributed and understood media for self management and monitoring. If successful, the intervention has the potential to influence how health promotion interventions are delivered through a general practice setting.
Trial website
Trial related presentations / publications
Pfaff JJ, Alfonso H, Newton RU, et al. ACTIVEDEP: a randomised, controlled trial of a home-based exercise intervention to alleviate depression in middle-aged and older adults. Br J Sports Med 2013;Jul 6. [Epub ahead of print].
Public notes

Contacts
Principal investigator
Name 29234 0
Prof Osvaldo Almeida
Address 29234 0
Western Australian Centre for Health & Ageing (M573) University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country 29234 0
Australia
Phone 29234 0
+61 8 92242855
Fax 29234 0
+61 8 92248009
Email 29234 0
osvaldo.almeida@uwa.edu.au
Contact person for public queries
Name 12481 0
Prof Osvaldo Almeida
Address 12481 0
Western Australian Centre for Health & Ageing (M573)
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 12481 0
Australia
Phone 12481 0
+61 8 92242855
Fax 12481 0
+61 8 92248009
Email 12481 0
osvaldo.almeida@uwa.edu.au
Contact person for scientific queries
Name 3409 0
Prof Osvaldo Almeida
Address 3409 0
Western Australian Centre for Health & Ageing (M573)
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 3409 0
Australia
Phone 3409 0
+61 8 92242855
Fax 3409 0
+61 8 92248009
Email 3409 0
osvaldo.almeida@uwa.edu.au

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