← Back to Search

Exercise Programs for Knee Pain (SMARTSTEP Trial)

Q: Is it possible to participate in this scientific experiment if one is under 75 years of age?

As mentioned in the trial's prerequisites, individuals between 18 and 89 years of age are qualified to take part.

Q: Is this research endeavor still accepting participants?

Affirmative. Based on information housed on clinicaltrials.gov, this medical trial has been actively searching for participants since August 24th 2018 and is still recruiting today. 50 patients are needed from a single site to complete the experiment.

Q: Am I eligible to participate in this medical investigation?

This clinical trial has the capacity to enrol fifty individuals aged between 18 and 89 who are currently experiencing peripheral arterial disorder. To qualify for participation, participants must present an Ankle-Brachial Index (ABI) of less than 0.9 after a period of rest or, if ABI is greater than 1.3, then a Toe-Brachial Index (<a href="https://www.withpower.com/clinical-trials/tbi">TBI</a>) below 0.7 should be obtained; additionally, in cases where ABI falls between 0.9 and 1., there needs to be evidence that this measure drops by 20% within one minute following treadmill testing.. Moreover, candidates need to have

Q: To what extent is participant participation in this research endeavor increasing?

Indeed, clinicaltrials.gov reports that this medical trial is currently enrolling participants. It was posted on August 24th 2018 and most recently refreshed on the same date in 2022; 50 patients are sought from a single site for inclusion in the study.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the 12-week study period

Awards & highlights

SMARTSTEP Trial Summary

This trial will compare the effectiveness of two different exercise programs for treating knee pain.

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.Check my eligibility

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.See study design

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.

SMARTSTEP Trial 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.

SMARTSTEP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

SMARTSTEP 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Woodruff Health Sciences Center FoundationUNKNOWN

1 Previous Clinical Trials

1,314 Total Patients Enrolled

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,646 Total Patients Enrolled

3 Trials studying Peripheral Arterial Disease

1,151 Patients Enrolled for Peripheral Arterial Disease

Amit Shah, MDPrincipal InvestigatorEmory University

Media Library

Peripheral Arterial Disease Research Study Groups: Smartphone-enabled structured exercise therapy (SE-SET), Standard exercise therapy

Peripheral Arterial Disease Clinical Trial 2023: Smartphone-enabled structured exercise therapy (SE-SET) Highlights & Side Effects. Trial Name: NCT03479255 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to participate in this scientific experiment if one is under 75 years of age?

"As mentioned in the trial's prerequisites, individuals between 18 and 89 years of age are qualified to take part."

Answered by AI

Is this research endeavor still accepting participants?

"Affirmative. Based on information housed on clinicaltrials.gov, this medical trial has been actively searching for participants since August 24th 2018 and is still recruiting today. 50 patients are needed from a single site to complete the experiment."

Answered by AI

Am I eligible to participate in this medical investigation?

"This clinical trial has the capacity to enrol fifty individuals aged between 18 and 89 who are currently experiencing peripheral arterial disorder. To qualify for participation, participants must present an Ankle-Brachial Index (ABI) of less than 0.9 after a period of rest or, if ABI is greater than 1.3, then a Toe-Brachial Index (TBI) below 0.7 should be obtained; additionally, in cases where ABI falls between 0.9 and 1., there needs to be evidence that this measure drops by 20% within one minute following treadmill testing.. Moreover, candidates need to have"

Answered by AI

To what extent is participant participation in this research endeavor increasing?

"Indeed, clinicaltrials.gov reports that this medical trial is currently enrolling participants. It was posted on August 24th 2018 and most recently refreshed on the same date in 2022; 50 patients are sought from a single site for inclusion in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Smartstep Smartphone PAD

Amit J. Shah 2018. "Smartstep Smartphone PAD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03479255.

All > Pad