Exercise Programs for Knee Pain

(SMARTSTEP Trial)

Overseen By Amit Shah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Sepsis, Critical limb ischemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two exercise programs for knee pain related to intermittent claudication, a condition causing leg pain due to poor blood flow. One group will use a smartphone app for guidance (smartphone-enabled structured exercise therapy, or SE-SET), while the other will follow exercises prescribed by their doctor (standard exercise therapy). The goal is to determine which method more effectively alleviates knee pain. Suitable participants have stable leg pain from poor circulation, can walk, but experience pain during exercise. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance exercise therapies for knee pain.

Will I have to stop taking my current medications?

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

What prior data suggests that these exercise programs are safe for knee pain?

Research has shown that using apps for exercise, such as smartphone-enabled structured exercise therapy (SE-SET), is safe for people with knee osteoarthritis. Studies have found that mobile apps for exercise typically do not cause serious side effects. Instead, they help manage symptoms and encourage healthy habits.

One study found app-based programs to be safe and effective, offering an easy way for patients to engage in physical therapy. These digital tools help patients adhere to their exercise routines and achieve better results. Users often report positive experiences, noting the apps' convenience and ease of use.

Overall, evidence suggests that SE-SET is well-tolerated and poses little risk to participants, making it a promising option for managing knee pain through guided exercise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for knee pain because the smartphone-enabled structured exercise therapy (SE-SET) offers a fresh approach to managing the condition. Unlike standard exercise therapies that rely heavily on self-direction, SE-SET integrates technology to enhance patient engagement and adherence. It includes daily exercise reminders, a virtual diary for tracking progress, secure messaging with a health coach, and educational videos, making it more interactive and personalized. These features aim to improve outcomes and provide patients with a more comprehensive support system for their rehabilitation journey.

What evidence suggests that this trial's exercise programs could be effective for knee pain?

This trial will compare two exercise programs for knee pain: Smartphone-enabled structured exercise therapy (SE-SET) and Standard exercise therapy. Research has shown that smartphone-based exercise programs, like SE-SET, can reduce knee pain and improve knee function. In studies, participants using online exercise programs reported less pain and better mobility after six weeks compared to those receiving regular care. Another study found that telehealth exercises helped individuals with knee osteoarthritis experience less pain and improved daily function. These findings suggest that smartphone apps can effectively manage knee pain. ^{5 6 7 8 9}

Who Is on the Research Team?

Amit Shah, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 with Peripheral Arterial Disease (PAD), who can consent and have specific Ankle-Brachial Index (ABI) or Toe-Brachial Index (TBI) scores indicating reduced blood flow. It's not for those whose walking is limited by other conditions, have life-threatening illnesses, severe heart failure, active behavioral issues that affect participation, or cannot attend study visits.

Inclusion Criteria

Able to give informed consent

I have leg pain from walking that stops when I rest.

If the blood pressure in your legs is too high or too low, it should drop by at least 20% after walking on a treadmill for 1 minute.

Exclusion Criteria

I cannot attend the study visits.

I have severe chest pain that is not stable.

I am currently experiencing a life-threatening condition like sepsis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week exercise program using either a smartphone-enabled app or standard physician-directed exercise therapy

12 weeks

Regular virtual check-ins via the app

Follow-up

Participants are monitored for changes in exercise capacity and cardiovascular outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smartphone-enabled structured exercise therapy (SE-SET)
• Standard exercise therapy

Trial Overview The trial compares a smartphone-enabled structured exercise therapy program with coaching to the usual physician-directed exercise therapy. The goal is to see if using smartphones for guided exercises helps people with PAD better than standard advice from their doctors.

How Is the Trial Designed?

Group I: Smartphone-enabled structured exercise therapy (SE-SET) Experimental Treatment 1 Intervention

This arm involves a smartphone app Movn - rehabilitation platform based on MULTIFIT, a case-management system for secondary prevention and patient surveillance after acute MI. The key features of the smartphone app include daily reminders to exercise, virtual diary for patients to enter data on exercise sessions, two-way secure messaging with the health coach, and educational videos on heart and vascular health.

Group II: Standard exercise therapy Active Control 1 Intervention

Self-directed, unsupervised exercise as prescribed by the patient's physician.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Woodruff Health Sciences Center Foundation

Collaborator

Trials

2

Recruited

1,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7903254/

Effectiveness of Internet-Based Exercises Aimed at Treating ... Patients receiving the internet-based program experienced decreased pain and improved function at 6 weeks vs the usual care group. Meaning.

2. jmir.org jmir.org/2025/1/e71558

Effectiveness of the Self-Directed mHealth Exercise ... Primary outcomes were OA-specific knee pain and physical function (using the subscales pain and activities in daily living of the Knee ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S3050708125000758

App-based exercise intervention versus supervised ... The results indicate a potential positive effect of app-based exercise at 6 weeks follow-up; however, we cannot conclude whether app-based exercise was ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11474128/

Effectiveness of Internet-Based Telehealth Programs in ... The findings showed that telehealth-based exercise is beneficial in reducing pain and improving function in knee OA. Yang et al [65] found that a 3-month ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07066514

Effectiveness of AI-Supervised Mobile Exercise Application ... This study may help determine whether AI-supported digital tools can improve exercise adherence and outcomes in patients with knee osteoarthritis. Official ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10006574/

Virtual Tools to Enable Management of Knee Osteoarthritis Mobile apps can monitor and track OA symptoms, exercise, and physical activity, while SMS can facilitate positive behaviour changes for self- ...

7. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-09201-x

Video-based physiotherapy assessment of knee osteoarthritis ... The purpose of this pilot study was to explore the feasibility of video-based physiotherapy assessment of KOA in patients with knee pain.

8. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887124006150

Effectiveness of Internet-Based Telehealth Programs in ... Physical therapy vs internet-based exercise training for patients with knee osteoarthritis: results of a randomized controlled trial. Osteoarthr Cartil, 26 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454192/

The Effect and Safety of App-Based Interventions for ... This study showed that app-based interventions were safe and effective for patients with OA, which might provide a cost-effective option, ...