Mobile Intervention Supervised Exercise Therapy Study 1

Study Overview
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Brief Summary
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This is a randomized controlled trial evaluating the impact of the mobile phone delivered SVS SET Program on utilization, functional capacity, symptoms and quality of life.

Detailed Description
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This is a national randomized controlled study with approximately 10-15 sites enrolling patients with Rutherford II peripheral artery disease (PAD) in total. Patients will be randomized between the SVS SET Program and usual care for each site. The primary outcome will be to study the site-specific effect on utilization of exercise therapy. Secondary outcomes will be the effect on the 6-minute-walk test, passive activity and quality of life.

Official Title
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Mobile Intervention Supervised Exercise Therapy Study 1

Conditions
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Peripheral Artery Disease, Claudication, Intermittent

Intervention / Treatment
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* Behavioral: Exercise Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of Age Rutherford Class I-II PAD (claudication) Ambulatory Exercise Therapy Naive (>18 mo) Primary Owner of an Android or iOS device Willingness to participate (text, call, fill out surveys) via a mobile phone Exclusion Criteria: Symptomatic coronary artery disease Oxygen dependent COPD Significant osteoarthritis limiting ambulation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomization stratified by site.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVS SET Program<br>Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription. | Behavioral: Exercise Therapy<br>* This is a health coach driven exercise prescription for patients recommending 30 minutes or more of moderate effort walking 3-5 days a week with expected walk-rest-walk-rest intervals.<br>|
| No Intervention: Usual Care<br>This usual care arm will allow sites to direct patients as they usually do. This could include an in-person exercise therapy program or simply exercise instruction during an office visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Complete a 12-week Exercise Therapy Program | Completion of a 12-week program in the treatment group will be completion of the remote SVS SET Program while the usual care group may have an in-person 12-week exercise therapy program. | 12 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobile Phone Delivered 6-Minute Walk Test | Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points. | Weeks 0, 6 and 12 | 
| Passive Activity as Measured on Mobile Device | Daily passive step count activity as measured by sensors in mobile phone. | 12 weeks. | 
| Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ) | QoL questionnaires will be asked on the mobile phone at three time points. | Weeks 1, 6, and 12 | 
| Adherence as Measured by Completion of Scheduled Daily Walks | Adherence to the recommended exercise therapy frequency (3 walks per week) and duration (for at least 30 minutes or more) will be measured | 12 weeks. | 
| Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year | Freedom from any surgical intervention will be reported at one year by performing a chart review. | 1 year. |