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

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ClinicalTrials.gov Identifier: NCT04706702
Recruitment Status : Not yet recruiting
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Kushang Patel, University of Washington

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Behavioral: Tele-EnhanceFitness Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of Tele-Exercise for Management of Knee Osteoarthritis in Older Rural Primary Care Patients
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : February 18, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tele-EF
Tele-EnhanceFitness
 Behavioral: Tele-EnhanceFitness
Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training


Outcome Measures
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Primary Outcome Measures :
  1. Active minutes per day [ Time Frame: Change from Baseline Active Minutes at 12 weeks ]
    Average number of minutes spent in moderate to vigorous physical activity as measured by the activPAL accelerometer


Secondary Outcome Measures :
  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function 8-item Short Form [ Time Frame: Change from Baseline PROMIS Physical Function score at 12 weeks ]
    Patient-reported physical functioning

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) Physical Function Subscale [ Time Frame: Change from Baseline KOOS Physical Function Subscale score at 12 weeks ]
    Patient-reported knee pain-related interference with physical functioning


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706702


Contacts
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Contact: Kushang V Patel, PhD 2066168052 kvpatel@uw.edu
Contact: Elise V Hoffman, BS 2066164671 evh3@uw.edu

Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195-6540
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Kushang V Patel, PhD University of Washington
More Information
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Responsible Party: Kushang Patel, Research Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT04706702    
Other Study ID Numbers: STUDY00012144
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases