Peripheral Arterial DiseaseSMARTSTEPNCT03479255
Smartstep Smartphone PAD
A study testing Smartphone-enabled structured exercise therapy (SE-SET) and Standard exercise therapy in people with Peripheral Arterial Disease, run by Emory University at 1 site in United States.
Trial summary
The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Smartphone-enabled structured exercise therapy (SE-SET) and Standard exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2018to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable intermittent claudication
- Able to give informed consent
- Age 18-89 years
- And one of the following:
- ABI < 0.9 after 10 minutes of rest OR
- For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.
Who cannot join
- Life-threatening process including:
- Sepsis
- Critical limb ischemia (Rutherford class 4-6)
- Unstable angina
- Active malignancy with life expectancy < 6 months
- Severe NYHA Class IV heart failure
Show all 13Show fewer
- Condition other than PAD that limits walking before claudication onset
- This includes, but is not limited to:
- Severe angina or dyspnea
- Arthritis
- Muscle weakness/pain
- Active behavioral conditions such as uncontrolled schizophrenia or illicit drug addiction that, in the opinion of the study team, will interfere with active participation
- Inability to attend study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Grady Health System (non-CRN)
Atlanta, Georgia, 30303
About this study
Official title: Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease
The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).
Read the detailed description
Structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. Coaching programs may help but requires significant resources. Smartphone programs may increase the efficiency of such efforts. The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care) in patients at Grady Memorial Hospital's vascular clinic.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Smartphone-enabled structured exercise therapy (SE-SET), Standard exercise therapy
- Keywords
- Smartphone, Exercise, Functional capacity
- Medical subject headings
- Peripheral Arterial Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-enabled structured exercise therapy (SE-SET)Behavioural
The SE-SET program lasts a total of 12 weeks per participant. During this time, the application will automatically track physical activity (steps) and subjects will be prompted to enter other health data such as blood pressure and weight and watch brief educational videos on topics such as smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. Patients will be contacted by a member of the study team weekly via phone call to identify barriers to patient compliance (issues related to exercise tracking, medication issues that prevent patients from being active, high BP/weight issues) and help patients navigate those barriers. Movn participants can also send direct messages to the study team to ask about non-urgent matters related to their care.
Standard exercise therapyBehavioural
The Standard exercise therapy lasts a total of 12 weeks per participant. Participants will be counseled by the physician to perform exercise at home, including 3 times per week of walking 30+ minutes; if applicable, the physician will also counsel on smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. These patients will be given a fitness band, which will be set up by the study team using a de-identified study account that will provide additional data on their progress over time.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-enabled structured exercise therapy (SE-SET) | Experimental | 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. Receives: Behavioral: Smartphone-enabled structured exercise therapy (SE-SET) |
| Standard exercise therapy | Active comparator | Self-directed, unsupervised exercise as prescribed by the patient's physician. Receives: Behavioral: Standard exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-minute walk test (6MWT) distance completed
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Immediately before and after the 12-week period
Secondary outcomes (9)
Change in Walking Impairment Questionnaire (WIQ) score
WIQ measures self-reported walking distance, speed, and stair-climbing ability. In the WIQ distance score, the participant is asked to assess the degree of walking difficulty in walking specific distances on a scale from 0 to 4. A score of 0 represents the inability to walk the distance and a score of 4 represents no difficulty. WIQ speed score assesses the degree of difficulty in walking one block at specific speeds, ranging from walking slowly to jogging, on a scale of 0 to 4. In the WIQ stair-climbing score, the participant is asked to report the degree of difficulty climbing specific numbers of flights of stairs, ranging from one to three flights of stairs, on a scale of 0 to 4. This graded score is multiplied by a prespecified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform any of the tasks) to 100 (representing no difficulty).
Measured: Immediately before and after the 12-week period
Change in Physical Health Composite Score of SF-36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to use special software. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Measured: Immediately before and after the 12-week period
Change in claudication onset time during 6MWT
One typical symptom of peripheral arterial occlusive disease' (PAOD) is claudication , which is defined as pain, cramps, numbness or a sense of fatigue in the muscles associated with walking, in one or both lower limbs, affecting either the distal or proximal muscle groups.
Measured: Immediately before and after the 12-week period
Change in ankle-brachial pressure index (ABPI)
The ankle-brachial pressure index (ABPI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABPI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm.
Measured: Immediately before and after the 12-week period
Change in number of steps/week
Number of steps/week will be obtained from participants' fitness trackers
Measured: Immediately before and after the 12-week period
Critical Limb Ischemia
Number of Critical Limb Ischemia events reported by participants
Measured: Over the 12-week study period
Other Cardiovascular Outcomes
Number of Cardiovascular Outcomes other than Critical Limb Ischemia events reported by participants
Measured: Over the 12-week study period
Exercise-Related Injury
Number of Exercise-Related Injury events reported by participants
Measured: Over the 12-week study period
Mortality
Number of deaths
Measured: Over the 12-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start24 Aug 2018
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective clinical trial that will randomize patients in 1:1 ratio to smartphone-enabled structured exercise therapy (SE-SET) vs. standard exercise therapy (usual care)
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Woodruff Health Sciences Center Foundation
- Responsible party
- Principal investigator, Amit J. Shah, Emory University
- Investigators
- Amit Shah, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479255
- Sponsor's protocol ID
- IRB00102543
- Acronym
- SMARTSTEP
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2018
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Enabled Supervised Exercise Therapy for the Treatment of Symptomatic Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT03479255
- Acronym / sponsor ID
- SMARTSTEP / IRB00102543
- Conditions
- Peripheral Arterial Disease
- Keywords
- Smartphone, Exercise, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Woodruff Health Sciences Center Foundation
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).
Detailed description
Structured exercise therapy is a first line treatment for symptomatic peripheral artery disease, but compliance is poor. Coaching programs may help but requires significant resources. Smartphone programs may increase the efficiency of such efforts. The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care) in patients at Grady Memorial Hospital's vascular clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective clinical trial that will randomize patients in 1:1 ratio to smartphone-enabled structured exercise therapy (SE-SET) vs. standard exercise therapy (usual care)
| Arm | Type | Receives |
|---|---|---|
| Smartphone-enabled structured exercise therapy (SE-SET) | Experimental | Behavioral: Smartphone-enabled structured exercise therapy (SE-SET)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. |
| Standard exercise therapy | Active comparator | Behavioral: Standard exercise therapySelf-directed, unsupervised exercise as prescribed by the patient's physician. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinically stable intermittent claudication
- Able to give informed consent
- Age 18-89 years
- ABI < 0.9 after 10 minutes of rest OR
- For subjects with an ABI of >1.3 (non-compressible arteries) a Toe-Brachial Index (TBI) of < 0.70 must be obtained for subject qualification. If ABI is > 0.9 to 1.0, a reduction of 20% in ABI must be measured within 1 minute of treadmill testing.
Key exclusion criteria (13 listed)
- Sepsis
- Critical limb ischemia (Rutherford class 4-6)
- Unstable angina
- Active malignancy with life expectancy < 6 months
- Severe NYHA Class IV heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-enabled structured exercise therapy (SE-SET)The SE-SET program lasts a total of 12 weeks per participant. During this time, the application will automatically track physical activity (steps) and subjects will be prompted to enter other health data such as blood pressure and weight and watch brief educational videos on topics such as smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. Patients will be contacted by a member of the study team weekly via phone call to identify barriers to patient compliance (issues related to exercise tracking, medication issues that prevent patients from being active, high BP/weight issues) and help patients navigate those barriers. Movn participants can also send direct messages to the study team to ask about non-urgent matters related to their care. | Behavioural | Smartphone-enabled structured exercise therapy (SE-SET) |
| Standard exercise therapyThe Standard exercise therapy lasts a total of 12 weeks per participant. Participants will be counseled by the physician to perform exercise at home, including 3 times per week of walking 30+ minutes; if applicable, the physician will also counsel on smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. These patients will be given a fitness band, which will be set up by the study team using a de-identified study account that will provide additional data on their progress over time. | Behavioural | Standard exercise therapy |
Primary outcome
Change in 6-minute walk test (6MWT) distance completed
Time frame: Immediately before and after the 12-week period
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
9 secondary outcomes
Change in Walking Impairment Questionnaire (WIQ) score
Time frame: Immediately before and after the 12-week period
Change in Physical Health Composite Score of SF-36
Time frame: Immediately before and after the 12-week period
Change in claudication onset time during 6MWT
Time frame: Immediately before and after the 12-week period
Change in ankle-brachial pressure index (ABPI)
Time frame: Immediately before and after the 12-week period
Change in number of steps/week
Time frame: Immediately before and after the 12-week period
Critical Limb Ischemia
Time frame: Over the 12-week study period
Other Cardiovascular Outcomes
Time frame: Over the 12-week study period
Exercise-Related Injury
Time frame: Over the 12-week study period
Mortality
Time frame: Over the 12-week study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Shah, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-enabled structured exercise therapy (SE-SET) and Standard exercise therapy in people with Peripheral Arterial Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-minute walk test (6MWT) distance completed (time frame: Immediately before and after the 12-week period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.