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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04706702
• Other study ID #: STUDY00012144
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: January 2021
• Source: University of Washington
• Contact: Kushang V Patel, PhD
• Phone: 2066168052
• Email: kvpatel[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: February 28, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Tele-EnhanceFitness
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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