Knee OsteoarthritisIWALQQ-OANCT03064139
Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA)
A study testing MCG and SCG in people with Knee Osteoarthritis, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This study evaluates the feasibility of a mindful walking intervention for management of knee osteoarthritis. Participants will be randomly assigned to receive one of two interventions i.e. mindful walking intervention or a self-care intervention. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MCG and SCG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 18 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 50-80 years
- BMI ≤40 kg/m2
- Meet American College of Rheumatology clinical and/or clinical+radiographic criteria for knee osteoarthritis
- Knee pain score ≥ 4 during last week
- Predominantly medial knee pain
- Predominantly medial knee radiographic osteoarthritis with or without radiographic patellofemoral osteoarthritis
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- Ability to ambulate for a minimum of 20 minutes, without any assistive device
- Available for the study duration
- Own a smartphone
- Can speak and understand English
Who cannot join
- Contraindications to exercise
- Using orthotics for knee pain such as knee braces, wedge insoles
- Knee injection in previous 3-months
- Currently receiving physical therapy for knee pain
- Planning major treatment for knee pain (e.g., physical therapy, surgery) in next 6 months
- Self-reported joint diseases like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, etc.
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- Self-reported total joint replacement in any lower extremity joint
- Self-reported neurological conditions like stroke, Parkinson's disease, etc.
- Self-reported muscular disease like muscle dystrophy
- Self-reported musculoskeletal or neurologic conditions that affect gait.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA): A Feasibility Study
This study evaluates the feasibility of a mindful walking intervention for management of knee osteoarthritis. Participants will be randomly assigned to receive one of two interventions i.e. mindful walking intervention or a self-care intervention.
Read the detailed description
People with knee osteoarthritis have low levels of physical activity, especially walking activity. They also walk with abnormal walking biomechanics that are associated with greater knee loading. Therefore, it is important to increase the levels of walking activity in people with knee osteoarthritis, but also change their walking patterns to reduce knee loading.
This study will last 12 months and participants will be randomized into 2 groups. For the first 6-months, half of the participants will attend sessions at a community location that include training in mindful walking technique. The other half will meet for the same frequency and duration at a community location for education on osteoarthritis and its management (focusing on symptom management, importance of physical activity, weight management, etc.). Both groups will also receive a wrist-worn activity monitor and a smartphone application that they will use throughout the study. After 6-months all participants will be allowed to practice on their own.
All participants will complete gait analysis, knee MRI, questionnaires, physical function assessment at baseline and at 6-months. All participants will also complete questionnaires at 3,9, and 12 months. Weekly physical activity and knee pain data will be collected using the mobile health technology for 12- months.
- Conditions
- Knee Osteoarthritis
- Being tested
- MCG, SCG
- Keywords
- physical activity, gait, biomechanics, mindfulness
- 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.
MCGBehavioural
Community-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels
SCGBehavioural
Community-based in person group education in management of knee osteoarthritis (importance of physical activity, weight management, etc.) over 11 sessions in 6 months + Activity monitor with feedback on activity levels
| Study group | Role | What they receive |
|---|---|---|
| MCG - Mindful Walking | Experimental | Participants will be trained in mindful walking technique Receives: Behavioral: MCG |
| SCG - Education and Self-Care | Active comparator | Participants will receive education in self-management of knee OA Receives: Behavioral: SCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence (in %)
Measured as % of in-person training sessions attended by participants
Measured: 6-months
Retention (in %)
Measured as the % of participants returning for the post-intervention assessment
Measured: 6-months
Secondary outcomes (3)
Medial knee contact force during walking (in Newton)
Medial knee contact force derived using an EMG-Driven musculoskeletal model
Measured: Change from baseline to 6-months
Average Daily Activity Count
Measured using an activity monitor worn by the participants
Measured: Change from baseline to 6-months
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Patient-reported outcome
Measured: Change from baseline to 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start7 Mar 2019
- Primary completion22 Sep 2020
- Study completion18 Mar 2021
Why it stopped: Study terminated early due to COVID-19. Interim data analyses in progress.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, University of Delaware
- Responsible party
- Sponsor
- Investigators
- Deepak Kumar, PT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064139
- Sponsor's protocol ID
- 4428E
- Acronym
- IWALQQ-OA
- Status last verified
- Jul 2022
- First submitted
- 14 Feb 2017
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee S, Neogi T, Costello KE, Senderling B, Stefanik JJ, Frey-Law L, Kumar D. Association of mechanical temporal summation of pain with muscle co-contraction during walking in people with knee osteoarthritis. Clin Biomech (Bristol). 2023 Dec;110:106105. doi: 10.1016/j.clinbiomech.2023.106105. Epub 2023 Sep 22.
PubMed 37778085
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA): A Feasibility Study
- ClinicalTrials.gov ID
- NCT03064139
- Acronym / sponsor ID
- IWALQQ-OA / 4428E
- Conditions
- Knee Osteoarthritis
- Keywords
- physical activity, gait, biomechanics, mindfulness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated early due to COVID-19. Interim data analyses in progress.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Boston University, University of Delaware
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 24 Feb 2017 (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.
This study evaluates the feasibility of a mindful walking intervention for management of knee osteoarthritis. Participants will be randomly assigned to receive one of two interventions i.e. mindful walking intervention or a self-care intervention.
Detailed description
People with knee osteoarthritis have low levels of physical activity, especially walking activity. They also walk with abnormal walking biomechanics that are associated with greater knee loading. Therefore, it is important to increase the levels of walking activity in people with knee osteoarthritis, but also change their walking patterns to reduce knee loading.
This study will last 12 months and participants will be randomized into 2 groups. For the first 6-months, half of the participants will attend sessions at a community location that include training in mindful walking technique. The other half will meet for the same frequency and duration at a community location for education on osteoarthritis and its management (focusing on symptom management, importance of physical activity, weight management, etc.). Both groups will also receive a wrist-worn activity monitor and a smartphone application that they will use throughout the study. After 6-months all participants will be allowed to practice on their own.
All participants will complete gait analysis, knee MRI, questionnaires, physical function assessment at baseline and at 6-months. All participants will also complete questionnaires at 3,9, and 12 months. Weekly physical activity and knee pain data will be collected using the mobile health technology for 12- months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCG - Mindful Walking | Experimental | Behavioral: MCGParticipants will be trained in mindful walking technique |
| SCG - Education and Self-Care | Active comparator | Behavioral: SCGParticipants will receive education in self-management of knee OA |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age 50-80 years
- BMI ≤40 kg/m2
- Meet American College of Rheumatology clinical and/or clinical+radiographic criteria for knee osteoarthritis
- Knee pain score ≥ 4 during last week
- Predominantly medial knee pain
Key exclusion criteria (10 listed)
- Contraindications to exercise
- Using orthotics for knee pain such as knee braces, wedge insoles
- Knee injection in previous 3-months
- Currently receiving physical therapy for knee pain
- Planning major treatment for knee pain (e.g., physical therapy, surgery) in next 6 months
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 |
|---|---|---|
| MCGCommunity-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels | Behavioural | MCG - Mindful Walking |
| SCGCommunity-based in person group education in management of knee osteoarthritis (importance of physical activity, weight management, etc.) over 11 sessions in 6 months + Activity monitor with feedback on activity levels | Behavioural | SCG - Education and Self-Care |
Primary outcome
Adherence (in %)
Time frame: 6-months
Measured as % of in-person training sessions attended by participants
Retention (in %)
Time frame: 6-months
Measured as the % of participants returning for the post-intervention assessment
3 secondary outcomes
Medial knee contact force during walking (in Newton)
Time frame: Change from baseline to 6-months
Average Daily Activity Count
Time frame: Change from baseline to 6-months
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Time frame: Change from baseline to 6-months
Results and safety
The study was stopped early (reason given: Study terminated early due to COVID-19. Interim data analyses in progress.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Derived from this study: PubMed 37778085Lee S, Neogi T, Costello KE, Senderling B, Stefanik JJ, Frey-Law L, Kumar D. Association of mechanical temporal summation of pain with muscle co-contraction during walking in people with knee osteoarthritis. Clin Biomech (Bristol). 2023 Dec;110:106105. doi: 10.1016/j.clinbiomech.2023.106105. Epub 2023 Sep 22.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Deepak Kumar, PT, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCG and SCG in people with Knee Osteoarthritis, run by Boston University Charles River Campus at 1 site in United States.
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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: Study terminated early due to COVID-19. Interim data analyses in progress.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (in %) (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064139, which also lists 1 linked publication.
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 20 Jul 2026.