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Trial registered on ANZCTR


Trial ID
ACTRN12605000252617
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
1/09/2005
Date last updated
1/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ENERGII Trial
Scientific title
A randomised phase III study to evaluate the effects of a 6 week nutrition support and 12 week resistance exercise program in the treatment of nutritionally at risk older adults to improve nutritional status, function, quality of life and health care utilization.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb fragility fracture 339 0
Condition category
Condition code
Other 392 392 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral nutritional supplement: 6 weeks of an individually prescribed supplement (6.3kJ/ml; 16% protein) administered via the medication cart by nursing staff on drug rounds. Thrice weekly visits for 6 weeks, weekly visits for 6 weeks.
Lower extremity progressive resistance training intervention: 12 weeks individualized resistance training program supervised by a physiotherapist using resistive elastic bands.
Combined nutritional supplement and resistance training intervention.
Usual care in addition to thrice weekly visits for 6 weeks and weekly visits for 6 weeks.
Intervention code [1] 220 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 449 0
Gait speed
Timepoint [1] 449 0
12 weeks
Secondary outcome [1] 981 0
Weekly weight change
Timepoint [1] 981 0
Week 1 through 12
Secondary outcome [2] 982 0
Corrected arm muscle area, albumin, prealbumin, grip strength
Timepoint [2] 982 0
Baseline, week 6 and week 12.
Secondary outcome [3] 983 0
Knee extensor strength
Timepoint [3] 983 0
Baseline, week 12.
Secondary outcome [4] 984 0
Quality of life
Timepoint [4] 984 0
Baseline, week 12.
Secondary outcome [5] 985 0
Length of stay, hospital readmission, admission to higher level care
Timepoint [5] 985 0
At 12 weeks.

Eligibility
Key inclusion criteria
Resident of southern Adelaide SA, admitted for treatment of a fall-related lower limb fragility fracture, independent mobility prior to admission, permitted to full weight bear within 7 days of injury, medically stable, mid arm circumference <25th percentile of a large representative sample of older Australians.
Minimum age
70 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Difficulty comprehending simple commands, rapidly progressive or terminal illness, gastrectomy, malabsorption or dysphagia, medical condition where strength training or supplementary feeding may be hazardous.

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)
Participant identification numbers were marked onto opaque sealed envelopes containing group allocation. The envelopes were opened in sequential order by an external clinical trials pharmacist as participants enrolled in the study. Once baseline assessments were complete, those who consented were randomly allocated to either of the four treatment groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations to the four treatment arms were computer-generated, stratified by admission accommodation (community; residential care), and randomized in blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 443 0
Commercial sector/Industry
Name [1] 443 0
Nutricia Australia Pty Ltd
Address [1] 443 0
Country [1] 443 0
Australia
Funding source category [2] 444 0
University
Name [2] 444 0
Flinders University South Australia
Address [2] 444 0
Country [2] 444 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 361 0
None
Name [1] 361 0
None
Address [1] 361 0
Country [1] 361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1416 0
Repatriation General Hospital
Ethics committee address [1] 1416 0
SA
Ethics committee country [1] 1416 0
Australia
Date submitted for ethics approval [1] 1416 0
Approval date [1] 1416 0
Ethics approval number [1] 1416 0
Ethics committee name [2] 1417 0
Flinders University/Flinders Medical Centre
Ethics committee address [2] 1417 0
SA
Ethics committee country [2] 1417 0
Australia
Date submitted for ethics approval [2] 1417 0
Approval date [2] 1417 0
Ethics approval number [2] 1417 0

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

Contacts
Principal investigator
Name 36381 0
Address 36381 0
Country 36381 0
Phone 36381 0
Fax 36381 0
Email 36381 0
Contact person for public queries
Name 9409 0
Prof. Maria Crotty
Address 9409 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9409 0
Australia
Phone 9409 0
+61 8 82751103
Fax 9409 0
+61 8 82751130
Email 9409 0
maria.crotty@rgh.sa.gov.au
Contact person for scientific queries
Name 337 0
Prof. Maria Crotty
Address 337 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 337 0
Australia
Phone 337 0
+61 8 82751103
Fax 337 0
+61 8 82751130
Email 337 0
maria.crotty@rgh.sa.gov.au