Clinical trial NCT04706702: Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients
Official title: Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Active minutes per day
timeFrame: Change from Baseline Active Minutes at 12 weeks
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
timeFrame: Change from Baseline PROMIS Physical Function score at 12 weeks
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
timeFrame: Change from Baseline KOOS Physical Function Subscale score at 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kushang V Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References: