Peripheral Artery DiseaseMiSET-1NCT04832308
Mobile Intervention Supervised Exercise Therapy Study 1
A study testing Exercise Therapy in people with Peripheral Artery Disease and Claudication, Intermittent, run by Palo Alto Veterans Institute for Research.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Claudication, Intermittent
- What is being tested?
- Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Symptomatic coronary artery disease
- Oxygen dependent COPD
- Significant osteoarthritis limiting ambulation
About this study
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.
Read the 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.
- Being tested
- Exercise Therapy
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SVS SET Program | Experimental | Participants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription. Receives: Behavioral: Exercise Therapy |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks.
Secondary outcomes (5)
Mobile Phone Delivered 6-Minute Walk Test
Mobile-phone delivered 6-minute walk test result in steps to be reported at three time points.
Measured: Weeks 0, 6 and 12
Passive Activity as Measured on Mobile Device
Daily passive step count activity as measured by sensors in mobile phone.
Measured: 12 weeks.
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.
Measured: Weeks 1, 6, and 12
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
Measured: 12 weeks.
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.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start20 Aug 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Why it stopped: Lack of grant funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomization stratified by site.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Vascular Surgery
- Responsible party
- Principal investigator, Oliver Aalami, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832308
- Sponsor's protocol ID
- 61023
- Acronym
- MiSET-1
- Status last verified
- Nov 2022
- First submitted
- 1 Apr 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Intervention Supervised Exercise Therapy Study 1
- ClinicalTrials.gov ID
- NCT04832308
- Acronym / sponsor ID
- MiSET-1 / 61023
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of grant funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Society for Vascular Surgery
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Block randomization stratified by site.
| Arm | Type | Receives |
|---|---|---|
| SVS SET Program | Experimental | Behavioral: Exercise TherapyParticipants enroll in SVS Program which includes 1) educational information on PAD, exercise and nutrition, 2) weekly health coaching, and 3) walking therapy prescription. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of Age
- Rutherford Class I-II PAD (claudication)
- Ambulatory
- Exercise Therapy Naive (>18 mo)
- Primary Owner of an Android or iOS device
Key exclusion criteria (3 listed)
- Symptomatic coronary artery disease
- Oxygen dependent COPD
- Significant osteoarthritis limiting ambulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TherapyThis 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. | Behavioural | SVS SET Program |
Primary outcome
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.
5 secondary outcomes
Mobile Phone Delivered 6-Minute Walk Test
Time frame: Weeks 0, 6 and 12
Passive Activity as Measured on Mobile Device
Time frame: 12 weeks.
Quality of Life Survey as measured by the mini-Walking Impairment Questionnaire (mini-WIQ)
Time frame: Weeks 1, 6, and 12
Adherence as Measured by Completion of Scheduled Daily Walks
Time frame: 12 weeks.
Freedom From Intervention as Measured by Absence of Surgical Intervention at One Year
Time frame: 1 year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Therapy in people with Peripheral Artery Disease and Claudication, Intermittent, run by Palo Alto Veterans Institute for Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Complete a 12-week Exercise Therapy Program (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.