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TerminatedNCT03064139IWALQQ-OAUpdated Jul 20, 2026

Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA)

An interventional study of MCG and SCG in Knee Osteoarthritis, sponsored by Boston University Charles River Campus. Terminated at 1 site in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-20.

Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment

Why this study was terminated
Study terminated early due to COVID-19. Interim data analyses in progress.
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • physical activity
  • gait
  • biomechanics
  • mindfulness
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 47 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Boston University Charles River Campus is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 8 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    MCG - Mindful Walking

    Participants will be trained in mindful walking technique

    Behavioral: MCG

  • Active comparator
    SCG - Education and Self-Care

    Participants will receive education in self-management of knee OA

    Behavioral: SCG

Interventions

  • BehavioralMCG

    Community-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels

  • BehavioralSCG

    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

06

What researchers measure

Primary outcomes

  1. Adherence (in %)

    Measured as % of in-person training sessions attended by participants

    Time frame: 6-months

  2. Retention (in %)

    Measured as the % of participants returning for the post-intervention assessment

    Time frame: 6-months

Secondary outcomes

  1. Medial knee contact force during walking (in Newton)

    Medial knee contact force derived using an EMG-Driven musculoskeletal model

    Time frame: Change from baseline to 6-months

  2. Average Daily Activity Count

    Measured using an activity monitor worn by the participants

    Time frame: Change from baseline to 6-months

  3. Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale

    Patient-reported outcome

    Time frame: Change from baseline to 6-months

Other outcomes

  1. Arthritis Self Efficacy Scale (ASES)

    Patient reported outcome

    Time frame: Change from baseline to 6-months

  2. Five Facet Mindfulness Questionnaire (FFMQ)

    Patient reported outcome

    Time frame: Change from baseline to 6-months

  3. Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire

    Patient reported outcome

    Time frame: Change from baseline to 6-months

  4. 30 second chair stand test (in counts)

    Number of time a participant can stand from a chair

    Time frame: Change from baseline to 6-months

  5. 40 meter fast paced walk test (in seconds)

    Time taken to cover 40 meters while walking at a fast pace

    Time frame: Change from baseline to 6-months

  6. Stair Climbing Test (in seconds)

    Time taken to ascend and descend a set of stairs

    Time frame: Change from baseline to 6-months

  7. Knee cartilage composition

    MRI t1rho and t2 relaxation times

    Time frame: Change from baseline to 6-months

  8. Pain sensitization

    Pressure pain threshold, Temporal summation, and conditioned pain modulation

    Time frame: Change from baseline to 6-months

07

Study locations

1 site
  • Boston University
    Boston, Massachusetts 02215, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03064139
Lead sponsor
Boston University Charles River Campus
Collaborators
Boston University, University of Delaware
Responsible party
Sponsor
First posted
Feb 24, 2017
Start date
Mar 7, 2019
Primary completion
Sep 22, 2020
Completion
Mar 18, 2021
Last update
Jul 20, 2026

Study contacts

Deepak Kumar, PT, PhD
principal investigator · Boston University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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