Mobile Intervention Supervised Exercise Therapy Study 1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- Palo Alto Veterans Institute for Research
- Primary Endpoint
- Number of Participants Who Complete a 12-week Exercise Therapy Program
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
Oliver Aalami
Clinical Associate Professor of Surgery
Stanford University
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
Outcomes
Primary Outcomes
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 Outcomes
- Adherence as Measured by Completion of Scheduled Daily Walks(12 weeks.)
- Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ)(Weeks 1, 6, and 12)
- Mobile Phone Delivered 6-Minute Walk Test(Weeks 0, 6 and 12)
- Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year(1 year.)
- Passive Activity as Measured on Mobile Device(12 weeks.)