NCT04099394

Brief Summary

This clinical trial will determine the added benefit of combining exercise and behavioral health education (versus exercise and aging and health education) to improve physical activity in community-dwelling older adults who have painful knee osteoarthritis (OA).

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

5.3 years

First QC Date

September 18, 2019

Last Update Submit

January 23, 2025

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritischronic painbehavioral healthexercisephysical activityolder adults

Outcome Measures

Primary Outcomes (1)

  • Average Number of Steps per day

    Participant's average number of steps per day will be measured by a thigh mounted accelerometer (acitvPAL) worn for 1 week.

    4 months,10 months

Secondary Outcomes (7)

  • Knee Pain and Function

    4 months, 10 months

  • 6 Minute Walk Test

    4 months, 10 months

  • Timed Up and Go Test

    4 months, 10 months

  • Short Physical Performance Battery

    4 months, 10 months

  • Fatigue

    4 months, 10 months

  • +2 more secondary outcomes

Study Arms (2)

Behavioral Health

EXPERIMENTAL

Ten behavioral health classes.

Behavioral: Behavioral Health

Health Education

ACTIVE COMPARATOR

Ten health education classes covering healthy aging.

Behavioral: Health Education

Interventions

Behavioral HealthBEHAVIORAL

Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.

Behavioral Health
Health EducationBEHAVIORAL

Ten, group-based classes lasting one hour each that teaches topics related to aging and health (e.g., blood pressure control, maintaining healthy bones, cancer screening, immunizations).

Health Education

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older
  • Community-dwelling
  • Physician diagnosis of knee OA
  • Knee pain that occurs almost daily for at least the past 3 months
  • Knee pain-related difficulty with walking or climbing stairs
  • Stiffness in the knee for \<30 min/day in the morning
  • Crepitus in the knee

You may not qualify if:

  • Non-English speaking
  • Cognitive impairment (Mini-Cog score ≤3)
  • Unable or unwilling to give informed consent or accept randomization in either study group
  • Unwilling to wear a thigh-mounted accelerometer for 1 week
  • Significant, non-corrected visual or hearing impairment
  • Plans to move out of the area in the next 12 months
  • Plans to have knee, hip, or any other major surgery (including joint replacement) in the next 12 months
  • Unable to walk a quarter of a mile independently (use of a straight cane is acceptable)
  • Prior participation in cognitive-behavioral therapy or counseling for pain
  • Exercises regularly (≥20 minutes/week of walking, hiking, dancing, or strength training, or participate in water exercise)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195-6540, United States

Location

Related Publications (7)

  • Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3.

    PMID: 27014966BACKGROUND

  • Leveille SG, Fried LP, McMullen W, Guralnik JM. Advancing the taxonomy of disability in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jan;59(1):86-93. doi: 10.1093/gerona/59.1.m86.

    PMID: 14718492BACKGROUND

  • Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.

    PMID: 24387819BACKGROUND

  • Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD004376. doi: 10.1002/14651858.CD004376.pub3.

    PMID: 25569281BACKGROUND

  • Newberry SJ, FitzGerald J, SooHoo NF, Booth M, Marks J, Motala A, Apaydin E, Chen C, Raaen L, Shanman R, Shekelle PG. Treatment of Osteoarthritis of the Knee: An Update Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 May. Report No.: 17-EHC011-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK447543/

    PMID: 28825779BACKGROUND

  • Focht BC. Effectiveness of exercise interventions in reducing pain symptoms among older adults with knee osteoarthritis: a review. J Aging Phys Act. 2006 Apr;14(2):212-35. doi: 10.1123/japa.14.2.212.

    PMID: 19462551BACKGROUND

  • Newman AB, Bayles CM, Milas CN, McTigue K, Williams K, Robare JF, Taylor CA, Albert SM, Kuller LH. The 10 keys to healthy aging: findings from an innovative prevention program in the community. J Aging Health. 2010 Aug;22(5):547-66. doi: 10.1177/0898264310363772. Epub 2010 May 21.

    PMID: 20495156BACKGROUND

MeSH Terms

Conditions

OsteoarthritisChronic PainMotor Activity

Interventions

Behavioral Medicine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Kushang V Patel, PhD MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor: School of Medicine: Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 23, 2019

Study Start

October 30, 2019

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)