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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Healthcare System

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stepped Exercise for Knee Osteoarthritis

Behavioral

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 outcomes

Western Ontario and McMaster Universities Osteoarthritis Index

Time frame: Baseline to 6 months

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 outcomes

30-second chair stand test

Time frame: Baseline to 6 months

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

Time frame: Baseline to 6 months

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.

Sponsors and collaborators

Lead sponsor

Durham VA Medical Center

Fed

Registry information

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Mar 1, 2021
Registry last updated: Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting