- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807541
The Effect of a Group Exercise Intervention on Balance in People With Knee Osteoarthritis: a Pilot Study
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gillian Hatfield, PhD
- Phone Number: 2217 1 604-504-7441
- Email: gillian.hatfield@ufv.ca
Study Locations
-
-
British Columbia
-
Chilliwack, British Columbia, Canada, V2R0N3
- Recruiting
- University of the Fraser Valley
-
Contact:
- Gillian Hatfield, PhD
- Phone Number: 2217 1 604-504-7441
- Email: gillian.hatfield@ufv.ca
-
Contact:
- Gillian Hatfield, PhD
-
Chilliwack, British Columbia, Canada, V2R0N3
- Not yet recruiting
- University of the Fraser Valley
-
Contact:
- Gillian Hatfield, PhD
- Phone Number: 2217 1 604-504-7441
- Email: gillian.hatfield@ufv.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Gillian Hatfield, PhD, University of the Fraser Valley
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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