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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-07

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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MCG - Mindful Walking

Participants will be trained in mindful walking technique

Group Type EXPERIMENTAL

MCG

Intervention Type BEHAVIORAL

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

SCG - Education and Self-Care

Participants will receive education in self-management of knee OA

Group Type ACTIVE_COMPARATOR

SCG

Intervention Type BEHAVIORAL

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

Interventions

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MCG

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

Intervention Type BEHAVIORAL

SCG

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No