Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04832308
Recruitment Status : Not yet recruiting
First Posted : April 5, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Oliver Aalami, Stanford University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Block randomization stratified by site.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mobile Intervention Supervised Exercise Therapy Study 1
Estimated Study Start Date : May 20, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants Who Complete a 12-week Exercise Therapy Program [ Time Frame: 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 :
  1. Mobile Phone Delivered 6-Minute Walk Test [ Time Frame: Weeks 0, 6 and 12 ]
    Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points.

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

  3. Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ) [ Time Frame: Weeks 1, 6, and 12 ]
    QoL questionnaires will be asked on the mobile phone at three time points.

  4. Adherence as Measured by Completion of Scheduled Daily Walks [ Time Frame: 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

  5. Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year [ Time Frame: 1 year. ]
    Freedom from any surgical intervention will be reported at one year by performing a chart review.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04832308


Contacts
Layout table for location contacts
Contact: Neera Maru 650-315-3236 neera@cell-ed.com
Contact: Oliver Aalami 650-315-3236 aalami@stanford.edu

Sponsors and Collaborators
Palo Alto Veterans Institute for Research
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Oliver Aalami, Clinical Associate Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT04832308    
Other Study ID Numbers: 61023
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases