19 Participants Needed

Telehealth Exercise Program for Osteoarthritis

KA
CL
Overseen ByChanee Lynch, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Durham VA Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

KA

Kelli Allen, PhD

Principal Investigator

Durham VAMC

Are You a Good Fit for This Trial?

This trial is for rural veterans who use VA healthcare, have a doctor's diagnosis of knee osteoarthritis, and experience knee pain rated at least 3 out of 10 with difficulty walking or climbing stairs.

Inclusion Criteria

Rural dwelling Veterans (VA healthcare users)
I have knee pain of 3 or more and trouble walking or climbing stairs.
I have been diagnosed with knee osteoarthritis by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Step 1: Self-directed Exercise Program

Participants begin with a low cost, primarily self-directed exercise program supported by an internet-based tool

2 months
Assessments via telephone or video

Step 2: Physical Activity Coaching

Participants receive bi-weekly telephone or video-based physical activity coaching if they do not make clinically relevant improvements in Step 1

2 months
Bi-weekly telephone or video calls

Step 3: Physical Therapy

Participants receive telehealth physical therapy visits if they do not make clinically relevant improvements in Step 2

2 months
3 telehealth PT visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Assessments at 2-, 4-, and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Stepped Exercise for Knee Osteoarthritis
Trial Overview The study tests a telehealth Stepped Exercise Program (STEP-KOA) for managing knee osteoarthritis. It starts with self-directed exercises and progresses to coaching calls and physical therapy based on symptom improvement over six months.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Stepped Exercise for Knee OsteoarthritisExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Durham VA Medical Center

Lead Sponsor

Trials
40
Recruited
9,300+
Unbiased ResultsWe believe in providing patients with all the options.
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