MiSET-1: Mobile Intervention Supervised Exercise Therapy Study 1

Sponsor

Palo Alto Veterans Institute for Research (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04832308

Collaborator

(none)

100

Enrollment

Arms

15.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease Claudication, Intermittent	Behavioral: Exercise Therapy	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Block randomization stratified by site.Block randomization stratified by site.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Mobile Intervention Supervised Exercise Therapy Study 1

Anticipated Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.
Passive Activity as Measured on Mobile Device [12 weeks.]
Daily passive step count activity as measured by sensors in mobile phone.
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.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Palo Alto Veterans Institute for Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Oliver Aalami, Clinical Associate Professor of Surgery, Stanford University

ClinicalTrials.gov Identifier:

NCT04832308

Other Study ID Numbers:

61023

First Posted:

Apr 5, 2021

Last Update Posted:

Apr 29, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peripheral Arterial Disease

Intermittent Claudication

Study Results

No Results Posted as of Apr 29, 2021