Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000017426
Ethics application status
Not yet submitted
Date submitted
18/12/2006
Date registered
10/01/2007
Date last updated
10/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Individual Nutrition Therapy and Exercise Regime: A Controlled Trial of Injured, Vulnerable Elderly.
Scientific title
A randomised controlled trial on improving gait speed and other health outcomes for elderly patients with hip fracture using an individualised nutrition and exercise program.
Universal Trial Number (UTN)
Trial acronym
INTERACTIVE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly people with a hip fracture 1518 0
Condition category
Condition code
Injuries and Accidents 1616 1616 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 month individualised exercise (tri-weekly, one hour muscle strengthening, balance training and walking) and nutrition therapy (small, frequent meals plus oral supplements or enteral feeds as appropriate to current nutritional status and nutritional rehabilitation goals) plan.
Intervention code [1] 1485 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care in addition to social visits to match the attention provided to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 2229 0
Gait speed
Timepoint [1] 2229 0
At 6 months
Secondary outcome [1] 3883 0
Physical function
Timepoint [1] 3883 0
Fortnightly for 6 months
Secondary outcome [2] 3884 0
Body composition
Timepoint [2] 3884 0
Fortnightly for 6 months
Secondary outcome [3] 3885 0
QoL
Timepoint [3] 3885 0
6 months
Secondary outcome [4] 3886 0
Caregiver burden
Timepoint [4] 3886 0
Weekly for 6 months
Secondary outcome [5] 3887 0
Cost and resource use
Timepoint [5] 3887 0
Daily for 6 months

Eligibility
Key inclusion criteria
Patients recovering from proximal femoral fracture (PFF) at Flinders Medical Centre (Adelaide). Ability to understand and comply with the requirements of the study.
Minimum age
70 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cognitive impairment (MMT <18/30), body mass index <18.5 kg/m2 and >30 kg/m2.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Outcome assessors will be blind to treatment allocation.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1763 0
Government body
Name [1] 1763 0
National Health and Medical Research Council (NHMRC) Project Grant
Country [1] 1763 0
Australia
Primary sponsor type
University
Name
Rehabilitation & Ageing Studies Unit, Flinders University
Address
Country
Australia
Secondary sponsor category [1] 1562 0
University
Name [1] 1562 0
Nutrition & Dietetics Department, Flinders University
Address [1] 1562 0
Country [1] 1562 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3288 0
Flinders Medical Centre / Flinders University
Ethics committee address [1] 3288 0
Ethics committee country [1] 3288 0
Australia
Date submitted for ethics approval [1] 3288 0
Approval date [1] 3288 0
Ethics approval number [1] 3288 0
Ethics committee name [2] 3289 0
Ryde Hospital
Ethics committee address [2] 3289 0
Ethics committee country [2] 3289 0
Australia
Date submitted for ethics approval [2] 3289 0
Approval date [2] 3289 0
Ethics approval number [2] 3289 0
Ethics committee name [3] 3290 0
Hornsby Ku-ring-gai Hospital
Ethics committee address [3] 3290 0
Ethics committee country [3] 3290 0
Australia
Date submitted for ethics approval [3] 3290 0
Approval date [3] 3290 0
Ethics approval number [3] 3290 0
Ethics committee name [4] 3291 0
Sydney University
Ethics committee address [4] 3291 0
Ethics committee country [4] 3291 0
Australia
Date submitted for ethics approval [4] 3291 0
Approval date [4] 3291 0
Ethics approval number [4] 3291 0

Summary
Brief summary
This study will use the best quality research methods to test whether providing a 6-month individualised exercise and nutrition program to hip fracture patients soon after injury improves walking and other important health outcomes. Patients will be followed for 12 months to determine what difference the exercise and and nutrition programs make. If they help then health services will have the evidence they need to recommend this type of program to the growing number of older Australians that suffer a hip fracture.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27419 0
Address 27419 0
Country 27419 0
Phone 27419 0
Fax 27419 0
Email 27419 0
Contact person for public queries
Name 10674 0
Dr Michelle Miller
Address 10674 0
Department of Nutrition & Dietetics
Flinders University
G4 Flinders Medical Centre (FMC) Flats
Flinders Drive
Bedford Park SA 5042
Country 10674 0
Australia
Phone 10674 0
+61 8 82045328
Fax 10674 0
Email 10674 0
michelle.miller@flinders.edu.au
Contact person for scientific queries
Name 1602 0
Dr Michelle Miller
Address 1602 0
Department of Nutrition & Dietetics
Flinders University
G4 Flinders Medical Centre (FMC) Flats
Flinders Drive
Bedford Park SA 5042
Country 1602 0
Australia
Phone 1602 0
+61 8 82045328
Fax 1602 0
Email 1602 0
michelle.miller@flinders.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.