Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000249550
Ethics application status
Approved
Date submitted
13/06/2006
Date registered
20/06/2006
Date last updated
20/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
UPLIFT study- Linking the health and leisure sectors: using physical activity in the management of depressive symptoms in older people with depression
Scientific title
UPLIFT study- Linking the health and leisure sectors: using progressive resistance training to reduce depressive symptoms in older people with depression
Universal Trial Number (UTN)
Trial acronym
UPLIFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive symptomatology 1228 0
Condition category
Condition code
Mental Health 1311 1311 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 10 week, 3 sessions per week, progressive resistance training program plus physical activity advice. Each session lasts 1 hour.
Intervention code [1] 1141 0
Treatment: Other
Comparator / control treatment
Physical advice alone
Control group
Active

Outcomes
Primary outcome [1] 1793 0
Reduction in depressive symptoms (measured on the Geriatric Depression Scale, GDS).
Timepoint [1] 1793 0
To assess the intervention's impact, scores at 10 weeks and 6 months follow up are compared with those at baseline.
Secondary outcome [1] 3148 0
Physical and psychological health, functional and quality of life status.
Timepoint [1] 3148 0
To assess the intervention's impact, scores at 10 weeks and 6 months follow up are compared with those at baseline.

Eligibility
Key inclusion criteria
GDS score 11-20, able to complete English language forms.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those currently receiving antidepressant treatment; depression with psychotic features; schizophrenia; bipolar disorder; suicidal ideation; dementia; terminally ill; uncontrolled hypertension (systolic blood pressure (SBP) above 210, diastolic blood pressure (DBP) above 110), unstable insulin dependent diabetes (two or more hypoglycaemic episodes in the previous 3 months); unstable angina; other psychiatric diagnoses; alcohol or drug related depression; those who do not speak English; those identified as unsuitable to exercise using the Physical Activity Readiness Questionnaire (PARQ).

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)
Random allocation from central point
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomisation using fixed blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1437 0
Charities/Societies/Foundations
Name [1] 1437 0
Beyondblue. Victorian Centre of Excellence in Depression and Related Disorders
Country [1] 1437 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 1271 0
None
Name [1] 1271 0
Nil
Address [1] 1271 0
Country [1] 1271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2812 0
Council on the Ageing (Victoria)
Ethics committee address [1] 2812 0
Ethics committee country [1] 2812 0
Australia
Date submitted for ethics approval [1] 2812 0
Approval date [1] 2812 0
01/08/2003
Ethics approval number [1] 2812 0
030233

Summary
Brief summary
AIMS: The aim is to test whether a 10-week progressive resistance training (PRT) program for depressed people aged 65 and over from the general practice setting will result in a reduced prevalence of depression at ten weeks and six months and a concomitant improvement in physical and psychological health, functional and quality of life status. The hypothesis to be tested is that the PRT program will produce a 60% reduction in depression rates amongst older people (akin to standard active therapies), compared to a 40% reduction in those receiving usual care.
BACKGROUND: The prevalence of depression in older people ranges from 5 to 30%. Depressive illness results in reduced activity levels, functional disability and decreased quality of life, and can occur concurrently with other illnesses (e.g., cardiovascular disease) and impact adversely on these conditions. Depressed older people have much to gain from being physically active, with benefits reported in both physical and mental health. Physical activity offers an alternative to drug management for some older people, reducing iatrogenic and polypharmacy problems. PRT is one form of physical activity with a growing evidence base in depression management. It is both timely and critical that we test the effectiveness of PRT in improving mental and physical health of older people with depression when applied in the Australian primary health care context.
RESEARCH PLAN: Older people will be recruited from primary and community care settings, via mailed invitations and referrals. Eligibility will be established via completion of the GDS-30 and medical clearance against proscribed criteria. Following baseline assessment, participants will be randomly allocated to a community-based, supervised PRT exercise program or usual care (comparison group). The PRT group will attend a local ‘Living Longer, Living Stronger’™ facility three times/week for 10 weeks. We will repeat baseline assessments at ten weeks and six months to determine whether the intervention’s impact is sustained. Sustainability is vital if the model is to be transferred into routine service delivery. Our approach will optimize the generalisability of study findings and the interventions’ subsequent adoption and implementation. Given the nature of the intervention, participants and exercise facilitators are not blinded to group allocation, but the data analyst is.
OUTCOMES & SIGNIFICANCE: The primary endpoint is a clinically significant reduction in depressive symptoms. The secondary endpoint is a significant improvement in health and wellbeing status, measured using the Human Activities Profile, the Philadelphia Geriatric Morale Scale and the WHOQOL-Bref.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36122 0
Address 36122 0
Country 36122 0
Phone 36122 0
Fax 36122 0
Email 36122 0
Contact person for public queries
Name 10330 0
Dr Jane Sims
Address 10330 0
Rehabilitation Science Research Centre
University of Melbourne
Royal Talbot Rehabilitation Centre 1 Yarra Bvd Kew VIC 3101
Country 10330 0
Australia
Phone 10330 0
+61 3 94907682
Fax 10330 0
+61 3 94907648
Email 10330 0
[email protected]
Contact person for scientific queries
Name 1258 0
Dr Jane Sims
Address 1258 0
Rehabilitation Science Research Centre
University of Melbourne
Royal Talbot Rehabilitation Centre 1 Yarra Bvd Kew VIC 3101
Country 1258 0
Australia
Phone 1258 0
+61 3 94907682
Fax 1258 0
+61 3 94907648
Email 1258 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
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