Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000553875
Ethics application status
Not yet submitted
Date submitted
21/05/2012
Date registered
24/05/2012
Date last updated
24/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial investigating the effect of the Home Activity Monitoring Program (HAMP) on functional status and falls in independent, home dwelling 65+ year old adults
Scientific title
A randomised controlled trial investigating the effect of the Home Activity Monitoring Program (HAMP) on functional status and falls in independent, home dwelling 65+ year old adults
Secondary ID [1] 280527 0
Nil
Universal Trial Number (UTN)
Trial acronym
HAMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 286520 0
Functional status 286521 0
Condition category
Condition code
Musculoskeletal 286785 286785 0 0
Other muscular and skeletal disorders
Injuries and Accidents 286814 286814 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An initial session will be conducted by an Exercise Physiologist to teach the intervention subjects the HAMP activities and exercises. This session will be approximately 60 minutes in duration and will include a series of simple physical exercises that can be completed at home with minimal equipment. The HAMP exercises are clearly explained in a booklet containing pictures and instructions which the intervention participants will take home to work from. The HAMP booklet contains a standard set of exercises for each intervention participant.
The home based activities and exercises are then to be completed independently within the participant's own home for a minumum of 30 minutes 3 times per week for a period of 12 weeks.
Telephone contact will be made with participants at weeks 3, 6 and 9. Additional calls will be taken at any time from subjects to support their participation. Intervention subjects will be re-assessed in week 13.
Intervention code [1] 284903 0
Lifestyle
Intervention code [2] 284922 0
Prevention
Intervention code [3] 284923 0
Behaviour
Comparator / control treatment
Control group subjects will be provided with once off general information on health and maintaining independence in the form of a brief 15 minute consultation with an Exercise Physiologist and will also be provided with a "Eat Well, Be Active" booklet. No contact will be made with control subjects over the intervention period. Control subjects will be offered the HAMP information and training, including telephone support following their final re-assessment in week 13.
Control group
Active

Outcomes
Primary outcome [1] 287156 0
6 Minute Walk Test
Timepoint [1] 287156 0
Week 0 and Week 13
Secondary outcome [1] 297516 0
Functional Reach Test
Timepoint [1] 297516 0
Week 0 and Week 13
Secondary outcome [2] 297517 0
Timed up and Go Test
Timepoint [2] 297517 0
Week 0 and Week 13
Secondary outcome [3] 297518 0
30 Second Sit to Stand Test
Timepoint [3] 297518 0
Week 0 and Week 13
Secondary outcome [4] 297519 0
Self-selected and Maximum Gait Speed
Timepoint [4] 297519 0
Week 0 and Week 13
Secondary outcome [5] 297567 0
Elderly Falls Screening Test
A self-reported questionnaire including 3 questions about falls in the last 12 months, injuries from falls and near falls.
Timepoint [5] 297567 0
Control subjects: Week 0 and Week 13
Intervention subjects: Week 0, 3, 6, 9, 12

Eligibility
Key inclusion criteria
65 years or older
Community residing;
Functionally independent;
Ambulatory with or without regular use of an assistive device;
Have no medical conditions or physical or cognitive limitations that would prohibit them from following instructions and participating safely in the outcome assessments and exercise intervention;
Not identified as having a falls risk as determined by the Elderly Falls Screening Test.
Medical Clearance by Associate Professor RK Penhall
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Less than 65 years of age
Not independent living
Non ambulant
Medical clearance not obtained
Identified as a falls risk (other than age)

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)
Participant eligibility will be determined, informed consent obtained and baseline outcome measures collected before the participant is allocated to a study group.
Sealed opaque envelopes will be used.
Central randomisation by phone by external party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software program (i.e. random computer sequence generation)
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285284 0
Charities/Societies/Foundations
Name [1] 285284 0
Northern Communities Health Foundation Inc
Country [1] 285284 0
Australia
Primary sponsor type
Government body
Name
Centre for Physical Activity in Ageing
Address
Hampstead Rehabilitation Centre
CPAA
207-255 Hampstead Rd
Northfield
SA 5085
Country
Australia
Secondary sponsor category [1] 284144 0
Charities/Societies/Foundations
Name [1] 284144 0
Active Ageing Australia
Address [1] 284144 0
105 Rundle St
Kent Town
SA 5067
Country [1] 284144 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287298 0
Royal Adelaide Hospital Research and Ethics Comittee
Ethics committee address [1] 287298 0
Ethics committee country [1] 287298 0
Australia
Date submitted for ethics approval [1] 287298 0
24/05/2012
Approval date [1] 287298 0
Ethics approval number [1] 287298 0

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

Contacts
Principal investigator
Name 34206 0
Address 34206 0
Country 34206 0
Phone 34206 0
Fax 34206 0
Email 34206 0
Contact person for public queries
Name 17453 0
Mr Robert Barnard
Address 17453 0
Centre for Physical Activity in Ageing
207-255 Hampstead Road
Northfield
SA 5085
Country 17453 0
Australia
Phone 17453 0
+61 8 8222 1889
Fax 17453 0
Email 17453 0
[email protected]
Contact person for scientific queries
Name 8381 0
Mr Robert Barnard
Address 8381 0
Centre for Physical Activity in Ageing
207-255 Hampstead Road
Northfield
SA 5085
Country 8381 0
Australia
Phone 8381 0
+61 8 8222 1889
Fax 8381 0
Email 8381 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.