Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients

Knee osteoarthritis (OA) is highly prevalent and a leading cause of pain that limits physical functioning in older adults. Clinical practice guidelines recommend physical exercise for managing symptoms of knee OA. As a result, several evidence-based exercise programs have been implemented in community centers. However, access to these programs is severely limited in rural settings. Considering that rural communities have a higher disease burden and higher proportion of older adults than non-rural areas, there is a critical need to (1) adapt evidence-based exercise programs for remote delivery to increase access for rural older adults and (2) develop pathways to implement exercise programs in rural health care systems that consistently reach and engage patients with knee OA. Accordingly, we aim to engage rural primary care practices (including medical directors, clinicians, and staff) to develop a clinical pathway that refers patients to an evidence-based exercise program, called Enhance Fitness® (EF), which we have adapted for remote delivery (tele-EF). Enhance Fitness is a group exercise program that is recommended by the CDC for OA management. It is available in over 800 sites nationally and is covered by Medicare Advantage plans, but it is generally not available in rural communities. In addition, we will assess the feasibility and acceptability of implementing the clinical pathway that identifies physically inactive older patients with knee OA, facilitates exercise prescription, and streamlines referral to tele-EF in a rural primary care clinic over a 5-month period.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Tele-EnhanceFitness

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kushang V Patel, PhD; Phone Number: 2066168052; Email: kvpatel@uw.edu
• Study Contact Backup: Name: Elise V Hoffman, BS; Phone Number: 2066164671; Email: evh3@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195-6540
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥65 years
• Community-dwelling
• English-speaking
• Physician diagnosed knee osteoarthritis
• Physically inactive as determined by the 2-item Physical Activity Vital Sign questionnaire

Exclusion Criteria:

• Cognitive impairment determined by a Mini Montreal Cognitive Assessment score of <11
• Significant, non-corrected visual or hearing impairment
• Plans to move out of the area in the next 6 months
• Cancer requiring treatment (except for non-melanoma skin cancer) in the past 6 months
• Heart attack in the past 6 months
• Stroke in the past 6 months
• Hip fracture in the past 6 months
• Hip/knee replacement in the past 6 months
• Spinal surgery in the past 6 months
• Heart surgery in the past 6 months
• Deep vein thrombosis in the past 6 months
• Pulmonary embolus in the past 6 months
• Hospitalization within the last month
• ≥3 falls within the past month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-EF; Tele-EnhanceFitness	Behavioral: Tele-EnhanceFitness; Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active minutes per day	Average number of minutes spent in moderate to vigorous physical activity as measured by the activPAL accelerometer	Change from Baseline Active Minutes at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale	Patient-reported knee pain-related interference with physical functioning	Change from Baseline KOOS Physical Function Subscale score at 12 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form	Patient-reported physical functioning	Change from Baseline PROMIS Physical Function score at 12 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Kushang V Patel, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): February 18, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 10, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 10, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: STUDY00012144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators recognize that data sharing leads to the promotion of science. We intend to publish the results of the proposed study and will make data available to investigators upon request (following publication). The final dataset will include demographic, clinical, and behavioral data on 15 older adults followed over a 3-month period. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the possibility of deductive disclosure of subjects with unusual characteristics remains. For these reasons, we propose to make the data and associated documentation available to users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No