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

NCT04706702 | Unknown

• 1 other identifier: STUDY00012144
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form

  Change from Baseline PROMIS Physical Function score at 12 weeks

• Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale

  Change from Baseline KOOS Physical Function Subscale score at 12 weeks

Study Arms (1)

Tele-EF

EXPERIMENTAL

Tele-EnhanceFitness

Behavioral: Tele-EnhanceFitness

Interventions

Tele-EnhanceFitness BEHAVIORAL

Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training

Tele-EF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195-6540, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kushang V Patel, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kushang V Patel, PhD

CONTACT

2066168052; kvpatel@uw.edu

Elise V Hoffman, BS

CONTACT

2066164671; evh3@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 13, 2021
• Study Start: March 1, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 28, 2022
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)