Knee OsteoarthritisNCT06807541
The Effect of a Group Exercise Intervention on Balance in People With Knee Osteoarthritis: a Pilot Study
A study testing Exercise intervention in people with Knee Osteoarthritis, run by University of the Fraser Valley at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Feb 2025to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
University of the Fraser Valley
Chilliwack, British Columbia, V2R0N3
Gillian Hatfield, PhD, 1 604-504-7441 ext. 2217, gillian.hatfield@ufv.ca
- Recruiting
University of the Fraser Valley
Chilliwack, British Columbia, V2R0N3
Gillian Hatfield, PhD, 1 604-504-7441 ext. 2217, gillian.hatfield@ufv.ca
Gillian Hatfield, PhD
About this 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercise intervention
- Keywords
- knee osteoarthritis, balance, exercise
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
45 minute exercise classes. Twice per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Experimental | Twice weekly exercise classes, for 12 weeks Receives: Behavioral: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance- Community Balance and Mobility Scale
Community Balance and Mobility Scale- scaled from 0 to 96, where higher scores indicate higher balance (better outcome).
Measured: From enrolment until the end of the treatment at 12 weeks.
Secondary outcomes (2)
Symptoms- Western Ontario and McMaster University Osteoarthritis Index
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.
Measured: From enrolment until the end of the treatment at 12 weeks.
Symptoms- Oxford Knee Score
The Oxford Knee Score is scored from 0-48, where higher scores are a better outcome.
Measured: From enrolment until the end of the treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start18 Feb 2025
- Primary completion19 Jun 2025 (estimated)
- Study completion19 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Fraser Valley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gillian Hatfield, PhD, Principal investigator, University of the Fraser Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807541
- Sponsor's protocol ID
- 101716
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Group Exercise Intervention on Balance in People With Knee Osteoarthritis: a Pilot Study
- ClinicalTrials.gov ID
- NCT06807541
- Acronym / sponsor ID
- 101716
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, balance, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of the Fraser ValleyUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 19 Jun 2025 (estimated)
- Study completion
- 19 Jun 2025 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Experimental | Behavioral: Exercise interventionTwice weekly exercise classes, for 12 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise intervention45 minute exercise classes. Twice per week for 12 weeks. | Behavioural | Exercise program |
Primary outcome
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).
2 secondary outcomes
Symptoms- Western Ontario and McMaster University Osteoarthritis Index
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gillian Hatfield, PhD principal investigator
University of the Fraser Valley
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Knee Osteoarthritis, run by University of the Fraser Valley at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gillian Hatfield, PhD (1 604-504-7441 ext. 2217, gillian.hatfield@ufv.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance- Community Balance and Mobility Scale (time frame: From enrolment until the end of the treatment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.