NCT00427843

Brief Summary

The purpose of this study is to determine the influence of a home program of exercises for the hip muscles which support the pelvis on walking patterns and hip muscle strength in people with knee osteoarthritis. Following a hip muscle strengthening program, we hypothesize that participants with knee osteoarthritis will demonstrate decreased loading at the knee joint during walking and greater strength of the hip muscles.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

October 1, 2008

Enrollment Period

1.3 years

First QC Date

January 25, 2007

Last Update Submit

October 14, 2008

Conditions

Keywords

osteoarthritiskneegaitmuscle strengthhipexercise

Outcome Measures

Primary Outcomes (2)

  • Walking variables: hip and knee abductor and adductor moments

    baseline and after 8 weeks

  • Muscle strength measures: isometric and isokinetic peak torque measures for the hip abductor and adductor muscles

    baseline and after 8 weeks

Secondary Outcomes (4)

  • Radiographs: lower limb frontal plane alignment measures - limb alignment in degrees; grading of knee osteoarthritis severity (total score out of 13)

    baseline

  • Speed of performance on the Five-Times-Sit-to-Stand Test

    baseline and after 8 weeks

  • Total score on the WOMAC pain subscale and the WOMAC physical function subscale

    baseline and after 8 weeks

  • Total score obtained for the physical activity scale (PASE)

    baseline and after 8 weeks

Study Arms (1)

Exercise Home-Based Program

EXPERIMENTAL

Patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. The exercise program will be performed 3 times per week for 8 weeks.

Behavioral: home exercise program for the hip abductor muscles

Interventions

All patients with knee OA will be taught a home-based exercise program for the hip abductor muscles during the initial visit. Patients will be instructed in the following program: contraction of the gluteus medius muscle during functional activities (gait, stepping sideways up on a step and standing on one leg); and side lying isotonic hip abduction exercises using graded resistance elastic bands positioned around the distal thighs. The program will be performed 3 times per week for 8 weeks and subjects will record exercise frequency and level of resistance on exercise calendars. Follow-up visits will occur at the end of week 1 and week 4 for review and progression of exercises. A telephone follow-up call will occur for support and participants will be encouraged to call with any questions or concerns.

Exercise Home-Based Program

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age greater than or equal to 40 years
  • self-reported pain in the knee(s) for most days of the month
  • at least some difficulty in daily function due to knee osteoarthritis
  • radiographic evidence of knee osteoarthritis or documented evidence of cartilage loss in the knee by arthroscopy surgery or magnetic resonance imaging.

You may not qualify if:

  • corticosteroid injection into either knee within the previous three months
  • other significant medical problems (including significant heart disease, stroke and active treatment for cancer) that would prevent participants from being able to perform a hip exercise program or to participate in tests of walking performance and hip muscle strength
  • known osteoarthritis or previous trauma affecting one or both hips
  • previous replacement of any joint in the lower extremities.
  • receiving rehabilitation services for knee osteoarthritis or performing a hip strengthening program at the time of testing
  • participants who have had a dual-energy x-ray absorptiometry (DEXA) for bone density analysis or more than one x-ray of the chest, abdomen or hip in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Rehabilitation Therapy, Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Related Publications (1)

  • Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Elsie G. Culham, PhD

    Queen's University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

September 1, 2008

Last Updated

October 15, 2008

Record last verified: 2008-10

Locations