Mobile Intervention Supervised Exercise Therapy Study 1 (MiSET-1)

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.

Study Overview

• Status: Withdrawn
• Conditions: Peripheral Artery Disease; Claudication, Intermittent
• Intervention / Treatment: Behavioral: Exercise Therapy

Detailed Description

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
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SVS SET Program; 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; 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.
No Intervention: Usual Care; 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?

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.

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: Society for Vascular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 61023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No