What side effects are associated with this type of intervention?

Common treatments for Peripheral Arterial Disease (PAD) include supervised exercise programs, pharmacological therapies, and revascularization procedures. Supervised exercise programs, such as walking to the point of claudication pain, are generally safe but may cause temporary discomfort or pain during exercise. Pharmacological treatments like cilostazol can improve symptoms but may cause headaches, diarrhea, and palpitations. Statins, often used to manage cholesterol levels in PAD patients, can lead to muscle pain and liver enzyme abnormalities. Revascularization procedures, including angioplasty, carry risks such as bleeding, infection, and, in rare cases, vessel damage or re-occlusion.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Arterial Disease (PAD), including pharmacological therapies and lifestyle interventions. Key pharmacological treatments include cilostazol, a phosphodiesterase inhibitor that improves walking distance, and antiplatelet agents like aspirin and clopidogrel, which reduce the risk of cardiovascular events. While there are no specific FDA approvals for smartphone-enabled exercise programs, supervised exercise therapy is a well-established non-pharmacological treatment for PAD. These exercise programs, often recommended in clinical guidelines, aim to improve walking distance and overall cardiovascular health. The Smartstep trial is exploring the effectiveness of a coached, smartphone-enabled exercise program, which represents an innovative approach to delivering supervised exercise therapy through digital health technology.

What other types of research exist?

Promising alternatives to a coached, smartphone-enabled exercise program for PAD patients include: 1) Supervised Exercise Therapy (SET), which has shown long-term effectiveness in improving walking performance. 2) Nordic Pole Walking, which has been effective in improving walking capacity. 3) High-Intensity Interval Training (HIIT), which has been systematically reviewed for its benefits in intermittent claudication. 4) Telehealth-supervised exercise programs, which have demonstrated feasibility and high patient satisfaction.

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Exercise Programs for Knee Pain (SMARTSTEP Trial)

Q: What is the mechanism of action of this treatment?

Exercise therapy, including supervised and technology-assisted programs like smartphone-enabled exercise coaching, is a cornerstone treatment for Peripheral Arterial Disease (PAD). These programs work by improving blood flow and enhancing the efficiency of the muscles in the lower extremities, which helps to alleviate symptoms of claudication. Regular exercise promotes the development of collateral circulation, reduces inflammation, and improves endothelial function. For PAD patients, this means reduced pain, increased walking distance, and overall better quality of life. The use of technology, such as smartphone applications, can provide personalized coaching and motivation, making it easier for patients to adhere to their exercise regimen and achieve better outcomes.

N/A

Recruiting

Led By Amit Shah, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-89 years

ABI < 0.9 after 10 minutes of rest

Must not have

Inability to attend study visits

Life-threatening process including unstable angina

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the 12-week study period

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects are not detailed in this summary, typical risks may include discomfort from increased physical activity or potential injuries related to exercise. The smartphone app itself should not cause direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 89 years old.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot attend the study visits.

Select...

I have severe chest pain that is not stable.

Select...

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

Select...

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

Select...

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

Select...

I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the 12-week study period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the 12-week study period

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the 12-week study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in 6-minute walk test (6MWT) distance completed

Secondary study objectives

Change in Physical Health Composite Score of SF-36

Change in Walking Impairment Questionnaire (WIQ) score

Change in ankle-brachial pressure index (ABPI)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Exercise therapy, including supervised and technology-assisted programs like smartphone-enabled exercise coaching, is a cornerstone treatment for Peripheral Arterial Disease (PAD). These programs work by improving blood flow and enhancing the efficiency of the muscles in the lower extremities, which helps to alleviate symptoms of claudication. Regular exercise promotes the development of collateral circulation, reduces inflammation, and improves endothelial function. For PAD patients, this means reduced pain, increased walking distance, and overall better quality of life. The use of technology, such as smartphone applications, can provide personalized coaching and motivation, making it easier for patients to adhere to their exercise regimen and achieve better outcomes.

Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication.