Improving Walking in Older Adults With Knee Osteoarthritis | NCT00583245

Studies
Improving Walking in Older Adults With Knee Osteoarthritis

NCT00583245

Sponsor

University of Iowa

Status

Completed

Last Update Posted

Mar 10, 2017Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Gait Training

Countries

United States

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

ID	Type	Description	Link
1K23AG030945-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2017

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

Dec 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 20, 2007

First Posted Date

Dec 31, 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

Mar 7, 2017

Last Update Posted Date

Mar 10, 2017Actual

Name	Class
National Institute on Aging (NIA)	NIH

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

Knee osteoarthritis (OA) accounts for a significant proportion of mobility limitations and is one of the most disabling problems facing the growing population of older adults. The long-term objective of this research is to reduce disablement of older adults with symptomatic knee OA. The principle of specificity of training indicates that exercises that closely approximate the goal functional activity are most effective in improving physical performance during that activity. Based on this principle, the specific aim of this pilot study is to design a patient-specific gait training intervention using analysis of compensatory joint moments and energy expenditure. Successful completion will inform rehabilitation for maintaining or improving mobility as well as explore the mechanism of effect.

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

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Gait training	Other: Gait Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gait Training	Other	Gait training with physical therapist 2/week for 3 months	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in functional limitation assessed by the A) Summary Performance Score which includes balance tests, timed 4-meter walk, and timed chair stand test B) Timed stair climb C) Late Life Function and Disability Instrument (LLFDI) Questionnaire		12 weeks
Changes in the disability measure, a timed 400 meter walk		12 Weeks
Changes in impairments assessed using the Knee and Osteoarthritis Outcome Score (KOOS) questionnaire		12 Weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic knee osteoarthritis (knee osteoarthritis diagnosed by x-ray and frequent knee symptoms)
Age 60 or older

Exclusion Criteria:

acute or terminal illness
unstable cardiovascular condition or other medical conditions that may impair ability to participate such as pulmonary disease requiring the use of supplemental oxygen, neurological disease that affects gait, or lower limb musculoskeletal surgery in the past 6 months.
Bilateral knee replacement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neil Segal, MD	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa		Iowa City	Iowa	52242	United States

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided