ArthritisNCT00527189
Balance Impairment and Falls Risk in People With Lower Limb Arthritis, and Can These be Improved With Exercise?
A study testing Balance Exercises in people with Arthritis, run by National Ageing Research Institute, Australia at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- Balance Exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteAustralia
- Study dates
- Jan 2006to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Lower limb osteoarthritis or lower limb rheumatoid arthritis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
National Ageing Research Institute
Melbourne, Victoria, 3052
About this study
Official 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?
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.
- Conditions
- Arthritis
- Being tested
- Balance Exercises
- Keywords
- Arthritis, Exercise, Balance - Postural Control
- Medical subject headings
- Arthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance ExercisesBehavioural
Home based balance exercises based on Otago Exercise programme
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Risk Human Activity Profile Confidence Balance Measures Gait Measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJan 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- National Ageing Research Institute, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health
- Investigators
- Keith Hill, PhD, Principal investigator, National Ageing Research Institue, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527189
- Sponsor's protocol ID
- 98765
- Status last verified
- Sep 2007
- First submitted
- 6 Sep 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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?
- ClinicalTrials.gov ID
- NCT00527189
- Acronym / sponsor ID
- 98765
- Conditions
- Arthritis
- Keywords
- Arthritis, Exercise, Balance - Postural Control
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Ageing Research Institute, AustraliaUniversity, hospital or other
- Collaborators
- Melbourne Health
- Study start
- Jan 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Lower limb osteoarthritis or lower limb rheumatoid arthritis
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance ExercisesHome based balance exercises based on Otago Exercise programme | Behavioural | – |
Primary outcome
Falls Risk Human Activity Profile Confidence Balance Measures Gait Measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Hill, PhD principal investigator
National Ageing Research Institue, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Exercises in people with Arthritis, run by National Ageing Research Institute, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Risk Human Activity Profile Confidence Balance Measures Gait Measures. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2007.