Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-EnhanceFitness
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tele-EF
Arm Description
Tele-EnhanceFitness
Outcomes
Primary Outcome Measures
Active minutes per day
Average number of minutes spent in moderate to vigorous physical activity as measured by the activPAL accelerometer
Secondary Outcome Measures
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
Patient-reported physical functioning
Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
Patient-reported knee pain-related interference with physical functioning
Full Information
NCT ID
NCT04706702
First Posted
January 8, 2021
Last Updated
January 10, 2021
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT04706702
Brief Title
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
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
February 18, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tele-EF
Arm Type
Experimental
Arm Description
Tele-EnhanceFitness
Intervention Type
Behavioral
Intervention Name(s)
Tele-EnhanceFitness
Intervention Description
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
Primary Outcome Measure Information:
Title
Active minutes per day
Description
Average number of minutes spent in moderate to vigorous physical activity as measured by the activPAL accelerometer
Time Frame
Change from Baseline Active Minutes at 12 weeks
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form
Description
Patient-reported physical functioning
Time Frame
Change from Baseline PROMIS Physical Function score at 12 weeks
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale
Description
Patient-reported knee pain-related interference with physical functioning
Time Frame
Change from Baseline KOOS Physical Function Subscale score at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kushang V Patel, PhD
Phone
2066168052
Email
kvpatel@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elise V Hoffman, BS
Phone
2066164671
Email
evh3@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kushang V Patel, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6540
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients
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