Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000369426
Ethics application status
Approved
Date submitted
2/07/2007
Date registered
13/07/2007
Date last updated
13/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of exercise on falls, fracture risk and perceived health in osteopenic women
Scientific title
Measuring the effects on balance, strength, bone density and perceived health of 6 months of workstation circuit style group exercises led by physiotherapists for osteopenic women aged 40-70.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia 1947 0
Fracture prevention 1948 0
Falls prevention 1949 0
Condition category
Condition code
Musculoskeletal 2044 2044 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a single exercise program which includes weight bearing functional exercises and specific balance strategy training exercises in a circuit-style class. Duration of intervention: 6 months, 2 x 1 hour sessions weekly. The group exercise is instructed and supervised by a Physiotherapist.
Intervention code [1] 1866 0
Prevention
Comparator / control treatment
The control group receives no intervention / treatment.
Control group
Active

Outcomes
Primary outcome [1] 2870 0
Balance (improvement in 10 clinical and laboratory measures)
Timepoint [1] 2870 0
Measured at baseline and 6-7 months after intervention commencement.
Primary outcome [2] 2871 0
Strength (improvement measured by hand held dynamometry)
Timepoint [2] 2871 0
Measured at baseline and 6-7 months after intervention commencement.
Primary outcome [3] 2872 0
Bone density (DEXA)
Timepoint [3] 2872 0
Measured at baseline and 6-7 months after intervention commencement.
Primary outcome [4] 2873 0
SF36
Timepoint [4] 2873 0
Measured at baseline and 6-7 months after intervention commencement.
Secondary outcome [1] 4841 0
Timepoint [1] 4841 0

Eligibility
Key inclusion criteria
Osteopenic as measured by Dual Energy X-Ray Absorptiometry (DEXA) (T score between -1.0 and -2.5) within past 6 months. No medical barriers to exercise twice weekly.Willing to undertake exercise program.
Minimum age
40 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal, neurological or cardiovascular pathology limiting ability to undertake exercises.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting holder of the allocation schedule at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2187 0
Government body
Name [1] 2187 0
Commonwealth Government NAMCIG grant (National Arthritis and Musculoskeletal Conditions Improvements scheme)
Country [1] 2187 0
Australia
Primary sponsor type
Individual
Name
Susan Hourigan
Address
Country
Secondary sponsor category [1] 1973 0
Individual
Name [1] 1973 0
Dr Jennifer Nitz
Address [1] 1973 0
Country [1] 1973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3984 0
University of Queensland MREC
Ethics committee address [1] 3984 0
Ethics committee country [1] 3984 0
Australia
Date submitted for ethics approval [1] 3984 0
Approval date [1] 3984 0
Ethics approval number [1] 3984 0
2004000562

Summary
Brief summary
The objective of this study was to determine the effects of a workstation balance training and weight-bearing exercise program on balance, strength and bone mineral density (BMD) in osteopenic women. As fracture risk has been related to poor balance, strength and BMD in previous literature it was foreseen that improvements in these measures would benefit women at increased risk of fracture through osteopenia. The intervention developed and utilised in this study is aimed at risk factors that are specific for fracture, falls prevention and the population of osteopenic women, it targets a condition that is of high prevalence in the community and uses outcome measures that are mostly easy to assess by clinicians.

Our hypothesis in this study was that a 20 week program of structured balance training and weight-bearing exercises delivered via workstation format would provide beneficial effects on three factors associated with fractures: balance, strength and bone density, in community-dwelling women with osteopenia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27680 0
Address 27680 0
Country 27680 0
Phone 27680 0
Fax 27680 0
Email 27680 0
Contact person for public queries
Name 11055 0
Dr Jennifer Nitz
Address 11055 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country 11055 0
Australia
Phone 11055 0
+61 7 33652791
Fax 11055 0
Email 11055 0
[email protected]
Contact person for scientific queries
Name 1983 0
Dr Jennifer Nitz
Address 1983 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country 1983 0
Australia
Phone 1983 0
+61 7 33652791
Fax 1983 0
Email 1983 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.