Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000335594
Ethics application status
Not required
Date submitted
26/04/2006
Date registered
8/08/2006
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of nutrition care and functional progressive resistance exercises on strength and improved mobility in older adults living in residential aged care.
Scientific title
The effects of nutrition care and functional progressive resistance exercises on mobility in older adults living in residential aged care.
Universal Trial Number (UTN)
Trial acronym
SNAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frail elderly 1305 0
Condition category
Condition code
Diet and Nutrition 1395 1395 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of two groups. All participants will receive usual care, however, one group will additionally receive strengthening exercises for the lower limbs together with nutrition care. These exercise sessions will last no longer than 45 minutes two times per week for 12 weeks. We will measure leg strength in the physiotherapy gymnasium before and after the 12 weeks of exercises and then one month after the exercises have finished to see if the effects are retained. Participants will also be interviewed by the Dietitian pre and post treatment and at a 4 week follow up to determine their nutrition risks, status, nutrition goals and nutrition care plan. There will be weekly follow up by the Dietitian and Nutrition Technician to check the effectiveness of the plan and achievement of goals.
Intervention code [1] 998 0
Rehabilitation
Comparator / control treatment
All participants will receive usual care, the control group will receive traditional general exercises together with nutrition care.
Control group
Active

Outcomes
Primary outcome [1] 1900 0
Functional mobility
Timepoint [1] 1900 0
Measured within 1 week before and 1 week after the 12 weeks of therapy as well as at a 4 week follow up after therapy has finished
Secondary outcome [1] 3365 0
Strength & nutrition
Timepoint [1] 3365 0
Measured within 1 week before and 1 week after the 12 weeks of therapy as well as at a 4 week follow up after therapy has finished.

Eligibility
Key inclusion criteria
To be included in the trial subjects will require written approval of their treating doctor, and will be further screened by the Physiotherapist that is working at the hostel who is independent and is not involved with the project. Inclusion criteria will thus include: approval of treating doctor, Mini Mental State Examination >23, resident of Kingston site residential aged care facility
Minimum age
21 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable acute or chronic medical condition, musculoskeletal or neurological conditions that will preclude the subject from participating in a 12 week exercise program, terminal illness or receiving chemotherapy, unable to walk 6 metres.

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)
Allocation will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book. Block randomisation will be employed in the study, with bocks of 14 and no stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Quasi experimental
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1529 0
Hospital
Name [1] 1529 0
Kingston Centre, Southern Health
Country [1] 1529 0
Australia
Primary sponsor type
Government body
Name
Kingston Centre, Southern Health
Address
Country
Australia
Secondary sponsor category [1] 1343 0
None
Name [1] 1343 0
Nil
Address [1] 1343 0
Country [1] 1343 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 2953 0
Southern Health Human Research Ethics Committee A
Ethics committee address [1] 2953 0
Ethics committee country [1] 2953 0
Australia
Date submitted for ethics approval [1] 2953 0
Approval date [1] 2953 0
Ethics approval number [1] 2953 0
06064A

Summary
Brief summary
This pilot study aims to compare the effect of (1) a nutrition care program and functional strength training with (2) a nutrition care program with conventional exercises in frail older people. Blinded testers will measure performance changes over time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35841 0
Address 35841 0
Country 35841 0
Phone 35841 0
Fax 35841 0
Email 35841 0
Contact person for public queries
Name 10187 0
Meg Morris
Address 10187 0
Allied Health Clinical Research Unit
Kingston Centre
Warrigal Rd
Cheltenham VIC 3192
Country 10187 0
Australia
Phone 10187 0
+61 3 92541000
Fax 10187 0
+61 3 92651577
Email 10187 0
[email protected]
Contact person for scientific queries
Name 1115 0
Professor Meg Morris
Address 1115 0
Allied Health Clinical Research Unit
Kingston Centre
Warrigal Rd
Cheltenham VIC 3192
Country 1115 0
Australia
Phone 1115 0
+61 3 92541000
Fax 1115 0
+61 3 92651577
Email 1115 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.