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
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Exercise, Physical Therapy
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
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
NCT ID
NCT04775589
First Posted
February 25, 2021
Last Updated
March 1, 2021
Sponsor
Durham VA Medical Center
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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