Mobile Intervention Supervised Exercise Therapy Study 1

Peripheral Artery Disease Clinical Trial

— MiSET-1  

Official title:

Mobile Intervention Supervised Exercise Therapy Study 1

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04832308
• Other study ID #: 61023
• Status: Withdrawn
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2022
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Claudication, Intermittent
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Society for Vascular Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Passive Activity as Measured on Mobile Device	Daily passive step count activity as measured by sensors in mobile phone.	12 weeks.
Secondary	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
Secondary	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.
Secondary	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.