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Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stepped Exercise for Knee Osteoarthritis
Sponsored by
Durham VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Exercise, Physical Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rural dwelling Veterans (VA healthcare users)
  • Clinician diagnosis of knee osteoarthritis
  • Self-reported knee pain =>3 on a scale of 0-10 and self-reported difficulty either walking or stair climbing.

Exclusion Criteria:

  • Advanced Dementia
  • Psychosis
  • Active substance abuse disorder
  • Meniscus or ACL tear in the past 6 months
  • Total joint replacement or other major lower extremity surgery in the past 6 months
  • Severe hearing or visual impairment (e.g. unable to participate in STEP-KOA intervention components)
  • Serious / terminal illness
  • Unstable angina
  • History of ventricular tachycardia
  • Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen)
  • Uncontrolled hypertension (diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg)
  • Stroke with moderate to severe aphasia
  • Recent history of falls
  • Resident of a long-term care facility
  • Hospitalization for a cardiovascular condition in the past 3 months
  • Other health conditions that would make home exercise unsafe or participation in the program not feasible

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Stepped Exercise for Knee Osteoarthritis

    Arm Description

    Patients start with a home-based exercise program, supported by an internet-based tool (Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps.

    Outcomes

    Primary Outcome Measures

    Western Ontario and McMaster Universities Osteoarthritis Index
    24-item measure assessing lower extremity pain, stiffness and function. All items are measured on a 5-point Likert scale (0-4; total score 0-96), with higher scores indicating worse symptoms.

    Secondary Outcome Measures

    30-second chair stand test
    Participants are asked to rise and sit back down in a chair as many times as they can during 30 seconds, without using hands or arms for support. Higher numbers of chair stands indicate better function.
    2 minute march test
    Participants are asked to march in place, taking as many "steps" as they can within 2 minutes, bringing the knees to approximately a 90-degree angle. If the patient is not bringing knees to an appropriate height, the study team member administering the test will ask them to raise their knees higher; if proper knee height cannot be maintained, the patient may continue the test, but this is noted on the score sheet. Higher numbers of steps indicate better function.

    Full Information

    First Posted
    February 25, 2021
    Last Updated
    March 1, 2021
    Sponsor
    Durham VA Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04775589
    Brief Title
    Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis
    Official Title
    Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Durham VA Medical Center

    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
    The goal of this study is to evaluate a telehealth Stepped Exercise Program for Knee OsteoArthritis (STEP-KOA) among rural veterans. Methods: This is a single arm, pre-post pilot trial of the 6-month STEP-KOA program among rural Veterans with a physician diagnosis of knee OA who self-report knee pain ≥3 on a 0-10 scale and self-reported difficulty with either walking or stair climbing. We aim to enroll 20 Veterans in this project but may enroll up to 30 in order to obtain sufficient information to evaluate the program, particularly among Veterans who live in very rural areas. Assessments will be conducted via a combination of telephone and video at baseline and 2-, 4-, and 6-month follow-up. Assessments will include questionnaires related to pain, function and physical activity, as well as several physical performance tests. STEP-KOA begins with a low cost, primarily self-directed exercise program (supported by an internet-based tool; Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps. For this project, patients will be assessed approximately every 2 months to determine step progression. Participants will advance to the next step if they do not meet response criteria for pain and function established by the Outcome Measures in Rheumatology group and the Osteoarthritis Research Society International (OMERACT-OARSI). The Step 2 intervention involves bi-weekly telephone or video calls. Step 3 involves 3 telehealth PT visits, based on standard care for knee OA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Exercise, Physical Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stepped Exercise for Knee Osteoarthritis
    Arm Type
    Experimental
    Arm Description
    Patients start with a home-based exercise program, supported by an internet-based tool (Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stepped Exercise for Knee Osteoarthritis
    Intervention Description
    Patients start with a home-based exercise program, supported by an internet-based tool (Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps
    Primary Outcome Measure Information:
    Title
    Western Ontario and McMaster Universities Osteoarthritis Index
    Description
    24-item measure assessing lower extremity pain, stiffness and function. All items are measured on a 5-point Likert scale (0-4; total score 0-96), with higher scores indicating worse symptoms.
    Time Frame
    Baseline to 6 months
    Secondary Outcome Measure Information:
    Title
    30-second chair stand test
    Description
    Participants are asked to rise and sit back down in a chair as many times as they can during 30 seconds, without using hands or arms for support. Higher numbers of chair stands indicate better function.
    Time Frame
    Baseline to 6 months
    Title
    2 minute march test
    Description
    Participants are asked to march in place, taking as many "steps" as they can within 2 minutes, bringing the knees to approximately a 90-degree angle. If the patient is not bringing knees to an appropriate height, the study team member administering the test will ask them to raise their knees higher; if proper knee height cannot be maintained, the patient may continue the test, but this is noted on the score sheet. Higher numbers of steps indicate better function.
    Time Frame
    Baseline to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Rural dwelling Veterans (VA healthcare users) Clinician diagnosis of knee osteoarthritis Self-reported knee pain =>3 on a scale of 0-10 and self-reported difficulty either walking or stair climbing. Exclusion Criteria: Advanced Dementia Psychosis Active substance abuse disorder Meniscus or ACL tear in the past 6 months Total joint replacement or other major lower extremity surgery in the past 6 months Severe hearing or visual impairment (e.g. unable to participate in STEP-KOA intervention components) Serious / terminal illness Unstable angina History of ventricular tachycardia Unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen) Uncontrolled hypertension (diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg) Stroke with moderate to severe aphasia Recent history of falls Resident of a long-term care facility Hospitalization for a cardiovascular condition in the past 3 months Other health conditions that would make home exercise unsafe or participation in the program not feasible
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kelli Allen, PhD
    Phone
    919-286-6936
    Email
    kelli.allen@va.gov
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chanee Lynch, MPH
    Phone
    919-286-6936
    Email
    chanee.lynch@va.gov

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

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