Mobile Intervention Supervised Exercise Therapy Study 1

Palo Alto Veterans Institute for Research

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Peripheral Artery Disease Claudication, Intermittent

Interventions

Exercise TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks.

Secondary Outcomes

Mobile Phone Delivered 6-Minute Walk Test

Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points.

Time frame: Weeks 0, 6 and 12

Passive Activity as Measured on Mobile Device

Daily passive step count activity as measured by sensors in mobile phone.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 1 year.

Data from ClinicalTrials.gov

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