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

Not Applicable

Suspended

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: MCG; Behavioral: SCG

• Registration Number: NCT03064139
• Lead Sponsor: Boston University Charles River Campus

Brief 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.

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 Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2019-03-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-27
• Primary Completion: 2022-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 62

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCG - Mindful Walking	MCG	Participants will be trained in mindful walking technique
SCG - Education and Self-Care	SCG	Participants will receive education in self-management of knee OA

Primary Outcome Measures

Name	Time	Method
Adherence (in %)	6-months	Measured as % of in-person training sessions attended by participants
Retention (in %)	6-months	Measured as the % of participants returning for the post-intervention assessment

Secondary Outcome Measures

Name	Time	Method
Medial knee contact force during walking (in Newton)	Change from baseline to 6-months	Medial knee contact force derived using an EMG-Driven musculoskeletal model
Average Daily Activity Count	Change from baseline to 6-months	Measured using an activity monitor worn by the participants
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale	Change from baseline to 6-months	Patient-reported outcome

Trial Locations

Locations (1)

Boston University; 🇺🇸 Boston, Massachusetts, United States