Balance Impairment and Falls Risk in People With Lower Li... | NCT00527189

Studies
Balance Impairment and Falls Risk in People With Lower Limb Arthritis, and Can These be Improved With Exercise?

NCT00527189

Sponsor

National Ageing Research Institute, Australia

Status

Completed

Last Update Posted

Sep 10, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Arthritis

Interventions

Balance Exercises

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Sep 6, 2007

First Submission Date that Met QC Criteria

Sep 7, 2007

First Posted Date

Sep 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2007

Last Update Posted Date

Sep 10, 2007Estimated

Name	Class
Melbourne Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Balance Exercises	Behavioral	Home based balance exercises based on Otago Exercise programme

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Falls Risk Human Activity Profile Confidence Balance Measures Gait Measures

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lower limb osteoarthritis or lower limb rheumatoid arthritis

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith Hill, PhD	National Ageing Research Institue, Australia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Ageing Research Institute		Melbourne	Victoria	3052	Australia

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis
D009043	Motor Activity

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided