Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00527189




Registration number
NCT00527189
Ethics application status
Date submitted
6/09/2007
Date registered
10/09/2007
Date last updated
10/09/2007

Titles & IDs
Public title
Balance Impairment and Falls Risk in People With Lower Limb Arthritis, and Can These be Improved With Exercise?
Scientific title
Which Measures of Balance Best Discriminate Balance Impairment and Falls Risk in People With Lower Limb Arthritis, and Can These be Improved With Exercise?
Secondary ID [1] 0 0
98765
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Balance Exercises

BEHAVIORAL: Balance Exercises
Home based balance exercises based on Otago Exercise programme
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Falls Risk Human Activity Profile Confidence Balance Measures Gait Measures
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Lower limb osteoarthritis or lower limb rheumatoid arthritis
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants were excluded if they:

* Did not have lower limb arthritis,
* Were bed bound,
* Had additional co-morbidities that confer risk of falls (such as Parkinson's disease, stroke, multiple sclerosis, history of cardiac syncope, epilepsy),
* Had undergone lower limb surgery within the previous twelve months, and/or
* Had synvisc or a corticosteroid injection within the last six months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
National Ageing Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
National Ageing Research Institute, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Arthritis has been reported as a risk factor for falls. Few studies have investigated the effect of balance training on balance performance in women with lower limb arthritis. The aim of this study was to evaluate the effectiveness of a four-month individualised home exercise programme in improving gait stability and balance for women with arthritis.
Trial website
https://clinicaltrials.gov/study/NCT00527189
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Keith Hill, PhD
Address 0 0
National Ageing Research Institue, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00527189