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

Knee Osteoarthritis Clinical Trial

— IWALQQ-OA  

Official title:

Improving Walking Quality and Quantity in Osteoarthritis (IWALQQ-OA): A Feasibility Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03064139
• Other study ID #: 4428E
• Status: Suspended
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: December 2022

Study information

• Verified date: July 2021
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 62
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston University Charles River Campus	Boston University, University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arthritis Self Efficacy Scale (ASES)	Patient reported outcome	Change from baseline to 6-months
Other	Five Facet Mindfulness Questionnaire (FFMQ)	Patient reported outcome	Change from baseline to 6-months
Other	Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire	Patient reported outcome	Change from baseline to 6-months
Other	30 second chair stand test (in counts)	Number of time a participant can stand from a chair	Change from baseline to 6-months
Other	40 meter fast paced walk test (in seconds)	Time taken to cover 40 meters while walking at a fast pace	Change from baseline to 6-months
Other	Stair Climbing Test (in seconds)	Time taken to ascend and descend a set of stairs	Change from baseline to 6-months
Other	Knee cartilage composition	MRI t1rho and t2 relaxation times	Change from baseline to 6-months
Other	Pain sensitization	Pressure pain threshold, Temporal summation, and conditioned pain modulation	Change from baseline to 6-months
Primary	Adherence (in %)	Measured as % of in-person training sessions attended by participants	6-months
Primary	Retention (in %)	Measured as the % of participants returning for the post-intervention assessment	6-months
Secondary	Medial knee contact force during walking (in Newton)	Medial knee contact force derived using an EMG-Driven musculoskeletal model	Change from baseline to 6-months
Secondary	Average Daily Activity Count	Measured using an activity monitor worn by the participants	Change from baseline to 6-months
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale	Patient-reported outcome	Change from baseline to 6-months