Mobile Intervention Supervised Exercise Therapy Study 1

Not Applicable

Withdrawn

• Conditions: Claudication, Intermittent; Peripheral Artery Disease
• Interventions: Behavioral: Exercise Therapy

• Registration Number: NCT04832308
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Study Start: 2021-08-20
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SVS SET Program	Exercise Therapy	Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Complete a 12-week Exercise Therapy Program	12 weeks.	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.

Secondary Outcome Measures

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