Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000331639
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
7/09/2005
Date last updated
7/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Resting energy expenditure of lower limb amputees
Scientific title
What is the resting metabolic rate of patients following a lower limb amputation? A pilot study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb amputation 422 0
Condition category
Condition code
Metabolic and Endocrine 492 492 0 0
Normal metabolism and endocrine development and function
Surgery 493 493 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 362 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 561 0
Resting metabolic rate
Timepoint [1] 561 0
Secondary outcome [1] 1193 0
Mean arm circumference
Timepoint [1] 1193 0
Secondary outcome [2] 1194 0
Tricep skinfold thickness
Timepoint [2] 1194 0
Secondary outcome [3] 1195 0
Mini nutritional assessment
Timepoint [3] 1195 0
Secondary outcome [4] 1196 0
Assessment of quality of life
Timepoint [4] 1196 0
Secondary outcome [5] 1197 0
Short form 36 questionnaire
Timepoint [5] 1197 0

Eligibility
Key inclusion criteria
Amputation of a lower limb (above ankle height), medically stable.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medication known to affect energy metabolism, diagnosed dementia.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 556 0
Self funded/Unfunded
Name [1] 556 0
Country [1] 556 0
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 450 0
None
Name [1] 450 0
None
Address [1] 450 0
Country [1] 450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1579 0
Repatriation General Hospital
Ethics committee address [1] 1579 0
Ethics committee country [1] 1579 0
Australia
Date submitted for ethics approval [1] 1579 0
Approval date [1] 1579 0
Ethics approval number [1] 1579 0

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

Contacts
Principal investigator
Name 35623 0
Address 35623 0
Country 35623 0
Phone 35623 0
Fax 35623 0
Email 35623 0
Contact person for public queries
Name 9551 0
Professor Maria Crotty
Address 9551 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9551 0
Australia
Phone 9551 0
+61 8 82751103
Fax 9551 0
+61 8 82751130
Email 9551 0
maria.crotty@rgh.sa.gov.au
Contact person for scientific queries
Name 479 0
Professor Maria Crotty
Address 479 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 479 0
Australia
Phone 479 0
+61 8 82751103
Fax 479 0
+61 8 82751130
Email 479 0
maria.crotty@rgh.sa.gov.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.