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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00414557
Other study ID # 040850
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 20, 2006
Last updated December 21, 2006
Start date May 2004
Est. completion date December 2006

Study information

Verified date December 2006
Source University of Melbourne
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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


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:

1. Quadriceps exercise over fulcrum using ankle weight

2. Straight leg raise exercise using ankle weight

3. Long arc knee extension exercise in sitting using ankle weight

4. Knee extension exercise with isometric hold at 60° knee flexion using ankle weight

5. 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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Quadriceps strengthening


Locations

Country Name City State
Australia The University of Melbourne Melbourne Victoria

Sponsors (3)

Lead Sponsor Collaborator
University of Melbourne Australian Physiotherapy Research Foundation, United Pacific Industries

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adduction moment
Primary Time points: 0 and 13 weeks
Secondary Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
Secondary Numerical rating scales for pain
Secondary Quadriceps and hamstrings strength
Secondary Self-selected walking speed
Secondary Dynamic balance using step test
Secondary Physical function using stair climb test
Secondary Time points: 0 and 13 weeks
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