ANZCTR - Registration

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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

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

Physical advice alone

Control group

Active

Outcomes

Primary outcome [1]

Reduction in depressive symptoms (measured on the Geriatric Depression Scale, GDS).

Timepoint [1]

To assess the intervention's impact, scores at 10 weeks and 6 months follow up are compared with those at baseline.

Secondary outcome [1]

Physical and psychological health, functional and quality of life status.

Timepoint [1]

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?

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]

Charities/Societies/Foundations

Name [1]

Beyondblue. Victorian Centre of Excellence in Depression and Related Disorders

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Council on the Ageing (Victoria)

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/08/2003

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Jane Sims

Address

Rehabilitation Science Research Centre
University of Melbourne
Royal Talbot Rehabilitation Centre 1 Yarra Bvd Kew VIC 3101

Country

Australia

Phone

+61 3 94907682

Fax

+61 3 94907648

j.sims@unimelb.edu.au

Contact person for scientific queries

Name

Dr Jane Sims

Address

Rehabilitation Science Research Centre
University of Melbourne
Royal Talbot Rehabilitation Centre 1 Yarra Bvd Kew VIC 3101

Country

Australia

Phone

+61 3 94907682

Fax

+61 3 94907648

j.sims@unimelb.edu.au

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.

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