Knee Malalignment and Thigh Muscle Strengthening in Indiv... | NCT00414557

Studies
Knee Malalignment and Thigh Muscle Strengthening in Individuals With Medial Knee Arthritis

NCT00414557

Sponsor

University of Melbourne

Status

Completed

Last Update Posted

Dec 22, 2006Estimated

Enrollment

107

Phase

Phase 2Phase 3

Conditions

Knee Osteoarthritis

Interventions

Quadriceps strengthening

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

Dec 2006

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

May 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Dec 20, 2006

First Submission Date that Met QC Criteria

Dec 20, 2006

First Posted Date

Dec 21, 2006Estimated

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

Dec 21, 2006

Last Update Posted Date

Dec 22, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of MelbourneOTHER

Collaborators

Name	Class
Australian Physiotherapy Research Foundation	OTHER
United Pacific Industries	UNKNOWN

Description Module

Brief Summary

To investigate the effects of quadriceps strengthening on the adductor moment in individuals with medial knee OA and whether quadriceps strengthening has a different effect on the adductor moment in individuals with and without knee malalignment

Detailed Description

Although quadriceps strengthening is the cornerstone of physiotherapy management, recent evidence suggests that high quadriceps strength in patients with malaligned knees may increase OA progression.

This study investigates the effects of quadriceps strengthening on the adduction moment in patients with medial knee OA with and without malalignment. 107 participants with and without varus knee malalignment were recruited and randomised into an exercise or a control group. Participants in the exercise group were taught five quadriceps strengthening exercises by a project physiotherapist to be performed five days a week for twelve weeks at home. The exercises were:

Quadriceps exercise over fulcrum using ankle weight
Straight leg raise exercise using ankle weight
Long arc knee extension exercise in sitting using ankle weight
Knee extension exercise with isometric hold at 60° knee flexion using ankle weight
Knee extension exercise with isometric hold at 60° knee flexion using an elastic band.

Each exercise was performed at 2x10 repetitions for the first 2 weeks and 3x10 repetitions thereafter.

Participants visited the physiotherapist 7 times at Week 1, 2, 3, 4, 5, 7 and 10. They were given the ankle weights and elastic band to bring home and instructed about the repetitions and weights to use by the physiotherapist, who also checked and progressed their exercises. The average duration of the physiotherapy sessions was 30 minutes. To monitor compliance, each participant was given an exercise instructions sheet and kept a training diary to record the exercises they had done.

The control group received no intervention.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

107

Name	Type	Description	Arm Group Labels	Other Names
Quadriceps strengthening	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adduction moment
Time points: 0 and 13 weeks

Secondary Outcomes

Measure	Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Numerical rating scales for pain
Quadriceps and hamstrings strength

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pain in the knee
Osteophytes on knee x-ray
Self-reported pain on the inner aspect of the study knee
Osteophytes in the medial compartment of the knee joint and
Medial joint space narrowing greater than lateral joint space narrowing on x-ray

Exclusion Criteria:

Knee surgery within the previous 6 months
History of lower limb joint replacements
Systemic arthritic conditions such as rheumatic or psoriatic arthritis
Valgus knee deformity (> 5º)
Inability to walk without the use of walking aids
Intending to start a lower limb strengthening program in the next 3 months
Seeking or currently receiving physiotherapy for OA knee

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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
Kim Bennell, PhD	University of Melbourne	Principal Investigator
Rana Hinman, PhD	University of Melbourne	Principal Investigator
Tim Wrigley, MSc	University of Melbourne	Principal Investigator
Boon W Lim, MSc	University of Melbourne	Principal Investigator
Leena Sharma, MD	Northwestern University Medical School, Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Melbourne		Melbourne	Victoria	3040	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18576289	Derived	Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823.

ID	Term
D020370	Osteoarthritis, Knee
D009140	Musculoskeletal Diseases
D007592	Joint Diseases

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D012216	Rheumatic Diseases