Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000475640
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
23/09/2005
Date last updated
31/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Late life intervention to improve function in elderly patients with depression
Scientific title
Does a home-based physical activity programme improve function and depressive symptomatology in older primary care patients: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
DeLLITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional impairment in depressed older people 596 0
Condition category
Condition code
Mental Health 669 669 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A trained research nurse conducts a functional assessment
Participant identifies a functional goal (with the assistance of the COPM)
Research nurse designs an individualised home-based physical activity programme based on attaining the functional goal
The intervention will be an adaptation of the Otago Exercise Programme - regular walking, three times weekly, progressive resistance training of lower leg strengthening using weights, and balance retraining using progressive balance exercises â¿¿ with the addition of arm strengthening exercises and tai chi exercises for balance.
Social contact will be encouraged by involvement of an exercise and walking companion.
The intervention nurse will visit on weeks 0, 1, 2, 4, 5, 8, and 12 (3 months) to ensure adherence and progression of activity. Participants will be encouraged to maintain the programme independently up to a total of 12 months.
Intervention code [1] 620 0
Prevention
Comparator / control treatment
Control group participants will receive social visits based on discussions of current social activities four times over three months to mirror the intervention group visits.
Control group
Active

Outcomes
Primary outcome [1] 794 0
Functional status: Change in Physical Performance score over time
Timepoint [1] 794 0
6months and 1 year
Primary outcome [2] 795 0
Functional status: Change in Timed Up and Go over time
Timepoint [2] 795 0
6 months and 1 year
Primary outcome [3] 796 0
Functional status: Change in the self reported Nottingham IADL scale over time
Timepoint [3] 796 0
6 months and 1 year
Secondary outcome [1] 1613 0
Depressive symptomatology: change in GDS score.
Timepoint [1] 1613 0
6 months and 1 year
Secondary outcome [2] 1614 0
Quality of life: change in SF-36 over time.
Timepoint [2] 1614 0
6 months and 1 year
Secondary outcome [3] 1615 0
Physical activity: change in AHS score.
Timepoint [3] 1615 0
6 months and 1 year
Secondary outcome [4] 1616 0
Sustainability of exercise.
Timepoint [4] 1616 0
6 months and 1 yearr

Eligibility
Key inclusion criteria
Eligible patients include those able to communicate in English, and screened as suffering from depression. Patients who are already on pharmacotherapy for depression will be eligible to participate in the trial.
Minimum age
75 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they suffer from dementia, terminal illness or an unstable cardiac condition, are unable to communicate in English, or are not living in Auckland permanently.

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)
An independent investigator in a distant site will hold a computer-generated randomisation schedule. After completion of baseline measures the recruitment nurse will telephone the independent researcher. The outcome assessor will remain blind to group randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment outside Australia
Country [1] 228 0
New Zealand
State/province [1] 228 0

Funding & Sponsors
Funding source category [1] 737 0
Government body
Name [1] 737 0
Health Research Council of NZ
Country [1] 737 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of NZ
Address
Grafton Road, Grafton, Auckland, 1001 NZ
Country
New Zealand
Secondary sponsor category [1] 611 0
University
Name [1] 611 0
University of Auckland Research Committee
Address [1] 611 0
univeristy of Auckland, Private BAg 92019
Auckland
Country [1] 611 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1932 0
Northern X Ethics Committee (Auckland)
Ethics committee address [1] 1932 0
Ethics committee country [1] 1932 0
New Zealand
Date submitted for ethics approval [1] 1932 0
Approval date [1] 1932 0
Ethics approval number [1] 1932 0

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

Contacts
Principal investigator
Name 35257 0
Address 35257 0
Country 35257 0
Phone 35257 0
Fax 35257 0
Email 35257 0
Contact person for public queries
Name 9809 0
Karen Hayman
Address 9809 0
Department of General Practice and Primary Health Care
School of Population Health
University of Auckland
Glen Innes 1065
Country 9809 0
New Zealand
Phone 9809 0
+64 9 3737999
Fax 9809 0
+64 9 3737624
Email 9809 0
k.hayman@auckland.ac.nz
Contact person for scientific queries
Name 737 0
Ngaire Kerse
Address 737 0
Department of General Practice and Primary Health Care
School of Population Health
University of Auckland
Glen Innes 1065
Country 737 0
New Zealand
Phone 737 0
+64 9 3737599 ext. 84467
Fax 737 0
+64 9 3737624
Email 737 0
n.kerse@auckland.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseExercise for depression.2013https://dx.doi.org/10.1002/14651858.CD004366.pub6
N.B. These documents automatically identified may not have been verified by the study sponsor.