Telehealth Exercise Program for Osteoarthritis

Overseen By Chanee Lynch, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Durham VA Medical Center

Disqualifiers: Dementia, Psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth exercise program for veterans with knee osteoarthritis, focusing on reducing knee pain and improving movement. The program, called Stepped Exercise for Knee Osteoarthritis, begins with self-directed exercises at home and can progress to video or phone coaching and physical therapy, depending on the participant's improvement. The trial aims to evaluate the effectiveness of this stepped approach, particularly for veterans in rural areas. It suits rural veterans diagnosed with knee osteoarthritis who experience knee pain and difficulty walking or climbing stairs. As an unphased trial, this study provides veterans the opportunity to explore innovative ways to manage knee osteoarthritis pain and enhance mobility.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this telehealth exercise program is safe for knee osteoarthritis?

Research has shown that the Stepped Exercise Program for Knee Osteoarthritis (STEP-KOA) is generally easy for participants to handle. In one study, 65% of participants advanced to more challenging exercises, indicating successful management of the initial stages. Another study focused on mindful exercise found no major safety concerns. Only four participants reported increased knee pain, a relatively small number. Overall, these findings suggest that the exercise program is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Stepped Exercise for Knee Osteoarthritis program is unique because it offers a progressive, personalized approach to managing osteoarthritis symptoms. Unlike standard treatments that often involve pain medications or traditional in-person physical therapy, this program starts with a home-based exercise regimen, supported by an internet tool, allowing patients to engage at their own pace. If additional support is needed, it steps up to include telephone or video-based coaching and eventually, physical therapy. Researchers are excited about this approach because it leverages telehealth technology to increase accessibility and adaptability, potentially improving patient outcomes and engagement without the need for immediate in-person visits.

What evidence suggests that this telehealth exercise program is effective for knee osteoarthritis?

Research has shown that the Stepped Exercise Program for Knee Osteoarthritis (STEP-KOA), which participants in this trial will follow, can help reduce pain and improve movement for people with knee osteoarthritis. One study found that participants in the STEP-KOA program experienced slight improvements in knee pain and movement after nine months. A review of multiple studies has shown that exercise programs supported by telehealth, like STEP-KOA, significantly reduce pain. These programs focus on the patient's needs and offer personalized exercise plans, making them both efficient and effective. Remote exercise methods also reach people in rural areas, providing support through video or phone calls. ^{6 7 8 9 10}

Who Is on the Research Team?

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 been diagnosed with knee osteoarthritis by a doctor.

I have knee pain of 3 or more and trouble walking or climbing stairs.

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?

Group I: Stepped Exercise for Knee Osteoarthritis Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Durham VA Medical Center

Lead Sponsor

Trials

40

Recruited

9,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10405203/

STepped Exercise Program for patients with Knee ... Participants in the STEP-KOA group reported modest improvements in the primary outcome (WOMAC) at 9-month follow-up (44), relative to the ...

2. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2627-8

STepped exercise program for patients with knee ... STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA.

3. jmir.org jmir.org/2024/1/e54876/

Telehealth-Supported Exercise or Physical Activity ... Results showed that telehealth-supported exercise or physical activity programs reduced pain (g=–0.39; 95% CI –0.67 to –0.11; P<.001), improved ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2665913122000322

Effectiveness of remote exercise programs in reducing pain ... This systematic review examined the efficacy of remote exercise programs for relieving pain in persons with knee OA.

5. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(21)01759-9/fulltext

Cost and Quality of Life Outcomes of the STepped Exercise ... The STEP-KOA (STepped Exercise Program for patients with Knee OsteoArthritis) improves pain and function, and the stepped care approach reserves ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6540433/

STepped exercise program for patients with knee ... This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA).

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33370174/

Stepped Exercise Program for Patients With Knee Osteoarthritis Results: In the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S266591312400061X

Telehealth mindful exercise for people with knee ... There were no adverse events in the mindful exercise group and four in the exercise group related to exacerbation of knee pain. Preliminary findings showed ...

9. oarsiopenjournal.com oarsiopenjournal.com/article/S2665-9131(24)00061-X/pdf

Telehealth mindful exercise for people with knee osteoarthritis Both groups received supervised group-based interventions weekly for 8-weeks via Zoom. Primary outcomes were safety, fidelity, and feasibility ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2665913122000395

“Much better than I thought it was going to be”: Telehealth ... 2) Telehealth participants reported similar program benefits to in-person participants, including reduced fear of pain and joint damage, changed beliefs in ...