Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000649617
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
17/10/2005
Date last updated
17/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing mobility after hip fracture
Scientific title
Enhancing mobility after hip fracture with an intensive weight-bearing exercise program
Universal Trial Number (UTN)
Trial acronym
EMAHF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 782 0
Condition category
Condition code
Injuries and Accidents 856 856 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. intensive weight-bearing exercise (experimental) group will undertake weight-bearing exercise twice daily for a total of 60 minutes, for four months.
Intervention code [1] 421 0
Rehabilitation
Comparator / control treatment
2. non-weight-bearing exercise (control) group will undertake 5 non-weight-bearing exercises plus a small amount of walking using parallel bars and/or walking aids for 30 minutes each day for 1 month, then a limited exercise program for a further 3 months.
Control group
Active

Outcomes
Primary outcome [1] 1098 0
1. Walking speed
Timepoint [1] 1098 0
At 1 and 4 months after recruitment
Primary outcome [2] 1099 0
2. Quadriceps strength on the fractured leg
Timepoint [2] 1099 0
At 1 and 4 months after recruitment
Secondary outcome [1] 2033 0
1. General mobility
Timepoint [1] 2033 0
At 1 and 4 months after recruitment.
Secondary outcome [2] 2034 0
2. Balance assessment
Timepoint [2] 2034 0
At 1 and 4 months after recruitment.
Secondary outcome [3] 2035 0
3. Activities of daily living
Timepoint [3] 2035 0
At 1 and 4 months after recruitment.

Eligibility
Key inclusion criteria
1. hip fracture with surgical fixation2. admitted to the rehabilitation ward3. approval from orthopaedic surgeon to weight-bear as tolerated or partial weight-bear4. able to tolerate all components of the control and experimental treatments5. at least able to take a minimum of four steps with a forearm support frame and the assistance of one person6. no medical contraindications that would limit ability to exercise (eg, severe cardiac failure)7. mild cognitive impairment or intact cognition based on the Short Portable Mental Status Questionnaire 26 8. living at home, independent living unit, or low care residential aged care facility (ie, hostel) prior to the hip fracture, with the plan to return to this accommodation at discharge.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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, sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software (Excel) generated with blocks of variable sizes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 942 0
Government body
Name [1] 942 0
NHMRC
Country [1] 942 0
Australia
Primary sponsor type
University
Name
Rehabilitation Studies Unit, University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 802 0
None
Name [1] 802 0
Nil
Address [1] 802 0
Country [1] 802 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2238 0
Hornsby Ku-ring-gai Hosptial
Ethics committee address [1] 2238 0
Ethics committee country [1] 2238 0
Australia
Date submitted for ethics approval [1] 2238 0
Approval date [1] 2238 0
Ethics approval number [1] 2238 0
Ethics committee name [2] 2239 0
Bankstown Lidcombe Hospital
Ethics committee address [2] 2239 0
Ethics committee country [2] 2239 0
Australia
Date submitted for ethics approval [2] 2239 0
Approval date [2] 2239 0
Ethics approval number [2] 2239 0
Ethics committee name [3] 2240 0
Royal Rehabilitation Centre Sydney
Ethics committee address [3] 2240 0
Ethics committee country [3] 2240 0
Australia
Date submitted for ethics approval [3] 2240 0
Approval date [3] 2240 0
Ethics approval number [3] 2240 0

Summary
Brief summary
The trial will determine the effects of intensive weight-bearing exercise after hip fracture. The outcome variables will be walking speed, quadriceps strength, mobility, balance, activities of daily living and quality of life. The experimental hypothesis is that intensive weight-bearing exercise will produce better mobility, strength, balance and other outcomes with no additional complications (including falls and fall related injuries) than non-weight-bearing exercise at 1 and 4 months after recruitment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35967 0
Address 35967 0
Country 35967 0
Phone 35967 0
Fax 35967 0
Email 35967 0
Contact person for public queries
Name 9610 0
Ian Cameron
Address 9610 0
Rehabilitation Studies Unit
University of Sydney
PO Box 6
Ryde NSW 1680
Country 9610 0
Australia
Phone 9610 0
+61 2 98089236
Fax 9610 0
+61 2 98099037
Email 9610 0
[email protected]
Contact person for scientific queries
Name 538 0
ian Cameron
Address 538 0
Rehabilitation Studies Unit
University of Sydney
PO Box 6
Ryde NSW 1680
Country 538 0
Australia
Phone 538 0
+61 2 98089236
Fax 538 0
+61 2 98099037
Email 538 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.