Exercise Programs for Knee Pain (SMARTSTEP Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByAmit Shah, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Emory University

No Placebo Group

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.

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

I am between 18 and 89 years old.

My ankle-brachial index is less than 0.9 after resting.

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.

I have severe leg pain or wounds due to poor blood flow.

My life expectancy is less than 6 months due to my cancer.

I have severe heart failure.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Smartphone-enabled structured exercise therapy (SE-SET)Experimental Treatment1 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 therapyActive Control1 Intervention

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