Smartstep Smartphone PAD

NCT03479255 | Completed DMC

• 1 other identifier: IRB00102543
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The study aim is to evaluate the effectiveness of a coached, smartphone-enabled exercise program versus physician directed exercise therapy (usual care).

Conditions

Peripheral Arterial Disease

Keywords

Smartphone; Exercise; Functional capacity

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately before and after the 12-week period

Secondary Outcomes (9)

• Change in Walking Impairment Questionnaire (WIQ) score

  Immediately before and after the 12-week period

• Change in Physical Health Composite Score of SF-36

  Immediately before and after the 12-week period

• Change in claudication onset time during 6MWT

  Immediately before and after the 12-week period

• Change in ankle-brachial pressure index (ABPI)

  Immediately before and after the 12-week period

• Change in number of steps/week

  Immediately before and after the 12-week period

Study Arms (2)

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.

Behavioral: Smartphone-enabled structured exercise therapy (SE-SET)

Standard exercise therapy

ACTIVE COMPARATOR

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

Behavioral: Standard exercise therapy

Interventions

Smartphone-enabled structured exercise therapy (SE-SET) BEHAVIORAL

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.

Smartphone-enabled structured exercise therapy (SE-SET)

Standard exercise therapy BEHAVIORAL

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.

Standard exercise therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Emory University: lead
• Woodruff Health Sciences Center Foundation: collaborator

Study Sites (1)

Grady Health System (non-CRN)

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Motor Activity

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Behavior

Study Officials

• Amit Shah, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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)

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: August 24, 2018
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

US (1)