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

Palo Alto Veterans Institute for Research

Status: Withdrawn

Conditions: Claudication, Intermittent; Peripheral Artery Disease

Treatments: Behavioral: Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04832308

61023

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

SVS SET Program

Experimental group

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.

Treatment:

Behavioral: Exercise Therapy

Usual Care

No Intervention group

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.