Peripheral Artery Disease Clinical Trial
— MiSET-1Official title:
Mobile Intervention Supervised Exercise Therapy Study 1
NCT number | NCT04832308 |
Other study ID # | 61023 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | August 20, 2021 |
Est. completion date | June 1, 2022 |
Verified date | November 2022 |
Source | Palo Alto Veterans Institute for Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Palo Alto Veterans Institute for Research | Society for Vascular Surgery |
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. |
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