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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a smartphone-based exercise program with coaching against the usual care given by doctors. It aims to help patients with peripheral artery disease who often struggle to follow exercise routines. The smartphone program could make it easier for them to stay on track and improve their health.

Research Team

Amit Shah, MD

Principal Investigator

Emory University

Eligibility Criteria

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

Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation

I cannot attend the study visits.

I have severe chest pain that is not stable.

Timeline

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

Treatment Details

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.

Participant Groups

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+