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

Primary Purpose

Knee Osteoarthritis

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MCG
SCG
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring physical activity, gait, biomechanics, mindfulness

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCG - Mindful Walking

SCG - Education and Self-Care

Arm Description

Participants will be trained in mindful walking technique

Participants will receive education in self-management of knee OA

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2017
Last Updated
July 20, 2021
Sponsor
Boston University Charles River Campus
Collaborators
Boston University, University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT03064139
Brief Title
Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA)
Acronym
IWALQQ-OA
Official Title
Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Suspended
Why Stopped
Study disrupted due to COVID-19. Interim data analyses in progress.
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
Boston University, University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
physical activity, gait, biomechanics, mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MCG - Mindful Walking
Arm Type
Experimental
Arm Description
Participants will be trained in mindful walking technique
Arm Title
SCG - Education and Self-Care
Arm Type
Active Comparator
Arm Description
Participants will receive education in self-management of knee OA
Intervention Type
Behavioral
Intervention Name(s)
MCG
Intervention Description
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
Intervention Name(s)
SCG
Intervention Description
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
Primary Outcome Measure Information:
Title
Adherence (in %)
Description
Measured as % of in-person training sessions attended by participants
Time Frame
6-months
Title
Retention (in %)
Description
Measured as the % of participants returning for the post-intervention assessment
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Medial knee contact force during walking (in Newton)
Description
Medial knee contact force derived using an EMG-Driven musculoskeletal model
Time Frame
Change from baseline to 6-months
Title
Average Daily Activity Count
Description
Measured using an activity monitor worn by the participants
Time Frame
Change from baseline to 6-months
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale
Description
Patient-reported outcome
Time Frame
Change from baseline to 6-months
Other Pre-specified Outcome Measures:
Title
Arthritis Self Efficacy Scale (ASES)
Description
Patient reported outcome
Time Frame
Change from baseline to 6-months
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
Patient reported outcome
Time Frame
Change from baseline to 6-months
Title
Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire
Description
Patient reported outcome
Time Frame
Change from baseline to 6-months
Title
30 second chair stand test (in counts)
Description
Number of time a participant can stand from a chair
Time Frame
Change from baseline to 6-months
Title
40 meter fast paced walk test (in seconds)
Description
Time taken to cover 40 meters while walking at a fast pace
Time Frame
Change from baseline to 6-months
Title
Stair Climbing Test (in seconds)
Description
Time taken to ascend and descend a set of stairs
Time Frame
Change from baseline to 6-months
Title
Knee cartilage composition
Description
MRI t1rho and t2 relaxation times
Time Frame
Change from baseline to 6-months
Title
Pain sensitization
Description
Pressure pain threshold, Temporal summation, and conditioned pain modulation
Time Frame
Change from baseline to 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Kumar, PT, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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