NCT03064139

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
2 years until next milestone

Study Start

First participant enrolled

March 7, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

3.1 years

First QC Date

February 14, 2017

Last Update Submit

July 20, 2021

Conditions

Knee Osteoarthritis

Keywords

physical activitygaitbiomechanicsmindfulness

Outcome Measures

Primary Outcomes (2)

  • Adherence (in %)

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

    6-months

  • Retention (in %)

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

    6-months

Secondary Outcomes (3)

  • Medial knee contact force during walking (in Newton)

    Change from baseline to 6-months

  • Average Daily Activity Count

    Change from baseline to 6-months

  • Knee injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale

    Change from baseline to 6-months

Other Outcomes (8)

  • Arthritis Self Efficacy Scale (ASES)

    Change from baseline to 6-months

  • Five Facet Mindfulness Questionnaire (FFMQ)

    Change from baseline to 6-months

  • Multidimensional Assessment of Interoceptive Awareness (MAIA) questionnaire

    Change from baseline to 6-months

  • +5 more other outcomes

Study Arms (2)

MCG - Mindful Walking

EXPERIMENTAL

Participants will be trained in mindful walking technique

Behavioral: MCG

SCG - Education and Self-Care

ACTIVE COMPARATOR

Participants will receive education in self-management of knee OA

Behavioral: SCG

Interventions

MCGBEHAVIORAL

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

MCG - Mindful Walking
SCGBEHAVIORAL

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

SCG - Education and Self-Care

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 37778085DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Deepak Kumar, PT, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 24, 2017

Study Start

March 7, 2019

Primary Completion

April 1, 2022

Study Completion

December 1, 2022

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

US(1)