The Effect of a Group Exercise Intervention on Balance in People With Knee Osteoarthritis: a Pilot Study

March 26, 2025 updated by: University of the Fraser Valley

In this study, the investigators want to find out if a 12-week exercise program improves balance in people with knee osteoarthritis.

This study will involve two visits to the School of Kinesiology at the University of the Fraser Valley (Chilliwack campus). Each visit will last approximately one hour. Participants will be asked to fill out questionnaires and complete a balance test. In between visits, participants will complete 12 weeks of an exercise program specifically designed for adults with osteoarthritis. Participants will do the exercise classes twice per week. Classes can be done in person or at home

Each exercise class is 45-minutes long and consists of flexibility, strength, and coordination exercises. In each class there are options to either increase or decrease the intensity of each exercise to cater to varying fitness levels and fluctuating symptoms. Each exercise has an assisted (using a chair for balance), body weight, and resisted (weight or exercise tubing) option. Participants will fill out an exercise diary each week to let the investigators know what days they did the exercise classes, and whether they experienced any changes in their knee osteoarthritis symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • British Columbia
      • Chilliwack, British Columbia, Canada, V2R0N3
        • Recruiting
        • University of the Fraser Valley
        • Contact:
        • Contact:
          • Gillian Hatfield, PhD
      • Chilliwack, British Columbia, Canada, V2R0N3
        • Not yet recruiting
        • University of the Fraser Valley
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medial compartment knee osteoarthritis, diagnosed from a physician or meeting the American College of Rheumatology Clinical Classification Criteria for Osteoarthritis of the knee
  • Pass the Get Active Questionnaire to ensure that they are safe to begin an exercise program

Exclusion Criteria:

i) severe knee trauma, knee surgery, or intraarticular knee joint injections in the previous six months ii) active synovitis iii) concurrent neurological (i.e. Parkinson's disease, Alzheimer's dementia, or polyneuropathy), endocrine (i.e., diabetes mellitus) and/or vestibular disorders which may affect balance iv) chronic disease that may put them at risk during the exercise classes (i.e., history of heart failure, stroke, chronic obstructive lung disease) v) uncorrected visual impairment which may affect balance vi) an inflammatory rheumatic disease (i.e., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic reactive arthritis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise program
Twice weekly exercise classes, for 12 weeks
45 minute exercise classes. Twice per week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance- Community Balance and Mobility Scale
Time Frame: From enrolment until the end of the treatment at 12 weeks.
Community Balance and Mobility Scale- scaled from 0 to 96, where higher scores indicate higher balance (better outcome).
From enrolment until the end of the treatment at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms- Western Ontario and McMaster University Osteoarthritis Index
Time Frame: From enrolment until the end of the treatment at 12 weeks.
Western Ontario and McMaster University (WOMAC) Osteoarthritis Index- Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
From enrolment until the end of the treatment at 12 weeks.
Symptoms- Oxford Knee Score
Time Frame: From enrolment until the end of the treatment at 12 weeks.
The Oxford Knee Score is scored from 0-48, where higher scores are a better outcome.
From enrolment until the end of the treatment at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gillian Hatfield, PhD, University of the Fraser Valley

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

June 19, 2025

Study Completion (Estimated)

June 19, 2025

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified pre and post intervention data (age, sex, height, mass, WOMAC and Oxford Knee Score scores, and Community Balance and Mobility Scores) will be shared on reasonable request.

IPD Sharing Time Frame

Available from August 2025 until August 2034

IPD Sharing Access Criteria

Data will be shared with other researchers at academic institutions. A proposal that describes planned analyses must be submitted and a data sharing agreement must be signed. Proposals may be submitted to the primary investigator for review.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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