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

Primary Purpose

Peripheral Artery Disease, Claudication, Intermittent

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise Therapy
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SVS SET Program

    Usual Care

    Arm Description

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

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Mobile Phone Delivered 6-Minute Walk Test
    Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points.
    Passive Activity as Measured on Mobile Device
    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)
    QoL questionnaires will be asked on the mobile phone at three time points.
    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
    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.

    Full Information

    First Posted
    April 1, 2021
    Last Updated
    November 2, 2022
    Sponsor
    Palo Alto Veterans Institute for Research
    Collaborators
    Society for Vascular Surgery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04832308
    Brief Title
    Mobile Intervention Supervised Exercise Therapy Study 1
    Acronym
    MiSET-1
    Official Title
    Mobile Intervention Supervised Exercise Therapy Study 1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of grant funding
    Study Start Date
    August 20, 2021 (Actual)
    Primary Completion Date
    June 1, 2022 (Actual)
    Study Completion Date
    June 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Palo Alto Veterans Institute for Research
    Collaborators
    Society for Vascular Surgery

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Artery Disease, Claudication, Intermittent

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Block randomization stratified by site.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SVS SET Program
    Arm Type
    Experimental
    Arm Description
    Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Complete a 12-week Exercise Therapy Program
    Description
    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 Outcome Measure Information:
    Title
    Mobile Phone Delivered 6-Minute Walk Test
    Description
    Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points.
    Time Frame
    Weeks 0, 6 and 12
    Title
    Passive Activity as Measured on Mobile Device
    Description
    Daily passive step count activity as measured by sensors in mobile phone.
    Time Frame
    12 weeks.
    Title
    Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ)
    Description
    QoL questionnaires will be asked on the mobile phone at three time points.
    Time Frame
    Weeks 1, 6, and 12
    Title
    Adherence as Measured by Completion of Scheduled Daily Walks
    Description
    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.
    Title
    Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year
    Description
    Freedom from any surgical intervention will be reported at one year by performing a chart review.
    Time Frame
    1 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Mobile Intervention Supervised Exercise Therapy Study 1

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