Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Stepped Exercise for Knee Osteoarthritis

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stepped Exercise for Knee Osteoarthritis; 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.

Behavioral: Stepped Exercise for Knee Osteoarthritis; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months
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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Durham VA Medical Center
• Investigators: Principal Investigator: Kelli Allen, PhD, Durham VAMC

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Physical Therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 15997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No