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Using Color Doppler Ultrasound to Promote Exercise in Adults with Peripheral Artery Disease

December 01, 2020
  • 00:00Hi bro, my name Sarah.
  • 00:01I'm a third year PhD student here at
  • 00:03Yale and today I'll be discussing with
  • 00:06you my thesis entitled Using color
  • 00:08Doppler ultrasound to promote exercise in
  • 00:10adults with peripheral artery disease.
  • 00:12Before I get started I want to
  • 00:14give a big thank you to my advisor,
  • 00:16Doctor Yakel who's a professor here
  • 00:18in the public health Department.
  • 00:20Here are a list of topics that
  • 00:22I'll be discussing with you today.
  • 00:24So what is peripheral artery
  • 00:25disease and why does it matter?
  • 00:28Peripheral artery disease is the
  • 00:29condition where plaque buildup in
  • 00:31the arteries and reduces oxygenated
  • 00:33blood flow to your limbs and
  • 00:35claudication is the first symptomatic
  • 00:36phase of peripheral artery disease.
  • 00:38Where you get leg pain when exercising
  • 00:40due to reduced blood flow to your limb
  • 00:43and eventually as the disease progresses,
  • 00:45you get tissue necrosis due
  • 00:47to lack of blood flow,
  • 00:49which will eventually lead
  • 00:50to amputation down the line.
  • 00:52An unfortunately piedi comes with an
  • 00:55increased cardiovascular event risk
  • 00:57starting even in the asymptomatic stage,
  • 00:59and this includes heart attacks, strokes,
  • 01:02heart failure, and vascular desk.
  • 01:05And these cardiovascular events
  • 01:06have high mortality rates with up
  • 01:09to 23% of people with PD dying from
  • 01:12coronary or cerebral vascular disease.
  • 01:14So PD prevalence and its impact on
  • 01:17the economy so 202 million people
  • 01:20worldwide have PhD with 70% coming
  • 01:22from low and middle income countries
  • 01:25and 30% from high income countries.
  • 01:27And this is a 23.5% increase from
  • 01:302000 due to our aging population
  • 01:33and increased risk factors such
  • 01:35as diabetes and obesity.
  • 01:37There are currently 12 million
  • 01:39people living with PD in the US an
  • 01:42this hospitalization rate in 2014.
  • 01:44Was 89.5 out of 100,000 people.
  • 01:47This brings a total annual cost of
  • 01:49these hospitalizations to be 6.31
  • 01:51billion dollars and then more than
  • 01:53half of these patients are discharged
  • 01:56to skilled nursing facilities or
  • 01:58need home health care.
  • 02:00Bring additional costs.
  • 02:01So what is PD treatment and why
  • 02:04is it not working?
  • 02:06First, there's medical management.
  • 02:07There's currently only two
  • 02:09medications approved for PAD and
  • 02:11only one of these medications,
  • 02:13Silas Diesel,
  • 02:13has shown to improve walking distances.
  • 02:16Unfortunately,
  • 02:16after 36 months less than 40% of
  • 02:19these people are adhering to the
  • 02:21medication due to the side effects,
  • 02:23so we don't have a good
  • 02:26medical management for piedi.
  • 02:27Next, there's surgical management,
  • 02:29which includes revascularization,
  • 02:30an amputation surgeries,
  • 02:31which come with a whole host
  • 02:33of complications.
  • 02:35So really,
  • 02:35behavioral management or exercise
  • 02:37is the first line treatment.
  • 02:39Exercise is known to improve
  • 02:41claudication symptoms in piedi outcomes.
  • 02:43However,
  • 02:43this is very counter intuitive because
  • 02:45if anyone is experiencing pain,
  • 02:47the natural human responses
  • 02:49to stop what you're doing.
  • 02:51But we know that it continuing
  • 02:54to exercise through this pain is
  • 02:56really the best treatment for PAD.
  • 02:59So people aren't really walking on their own,
  • 03:01and that's led to the medical community
  • 03:04creating things such as supervised
  • 03:06exercise training programs where
  • 03:07patients will go to a facility and
  • 03:09their supervised as they walk on a
  • 03:11treadmill by physicians
  • 03:12and their support teams.
  • 03:14And this is the gold standard,
  • 03:16but unfortunately,
  • 03:16a study found that 76% of screen
  • 03:19people were not able or willing to
  • 03:21participate due to barriers such as cost,
  • 03:23travel time and access.
  • 03:24So then this then led to structured
  • 03:26home exercise programs to try to
  • 03:29eliminate some of these barriers.
  • 03:31However, the successful studies still
  • 03:33have used things such as coaches,
  • 03:35logs and psychiatrists which
  • 03:36come with barriers in themselves.
  • 03:38So this is the problem.
  • 03:40Exercise is known to improve
  • 03:42claudication symptoms in PD outcomes,
  • 03:44but people aren't exercising these
  • 03:46supervised and home exercise programs
  • 03:48aren't working due to barriers,
  • 03:50and we also know that additional barriers,
  • 03:52such as poor understanding of how
  • 03:55walking helps alleviate symptoms,
  • 03:56fear of claudication, pain,
  • 03:58and perceived lack of control
  • 04:00over the disease. Also exist.
  • 04:02So among a different patient population,
  • 04:05coronary artery disease patients,
  • 04:07they've used image Ng to positively
  • 04:09change exercise behaviors,
  • 04:11and so we're hoping to do a similar
  • 04:14thing here with the padz population by
  • 04:16using color Doppler ultrasound show
  • 04:19patients their vasculature during
  • 04:21exercise associated claudication in
  • 04:23order to increase home exercise adherence.
  • 04:27So the research question is,
  • 04:29will using color Doppler ultrasonography
  • 04:30during claudication pain increase
  • 04:32exercise adherence among adults
  • 04:33with intermittent claudication,
  • 04:34peripheral artery disease?
  • 04:36And you can see my hypothesis below.
  • 04:38So the methods this will be a single
  • 04:41blinded randomized control trial
  • 04:42that will take about two years with
  • 04:45two to three months for approval,
  • 04:4716 months for recruitment in
  • 04:49the initial appointments,
  • 04:50five months for the home exercise portion
  • 04:52and the post intervention appointment,
  • 04:55and then about three months for data.
  • 04:57Analysis it will include English
  • 04:59speaking adults 45 to 7 years old with
  • 05:02intermittent claudication PhD with the
  • 05:04disease burden in the popliteal artery,
  • 05:07and this is important because we want
  • 05:09the disease burden to be Anna vessel
  • 05:12that's near their claudication pain,
  • 05:14which is typically in the calf.
  • 05:17An it will include 50 subjects,
  • 05:19so the control group will
  • 05:21perform a graded treadmill test,
  • 05:23which is basically when they're on
  • 05:26the treadmill and overtime the grade.
  • 05:28Over the steepness of the
  • 05:30treadmill increases,
  • 05:31making it more challenging and
  • 05:33they won't see their images.
  • 05:34And then the experimental group will
  • 05:36look at their color Doppler ultrasound
  • 05:39images taken during this graded treadmill
  • 05:41test at different levels of pain.
  • 05:43The primary dependent variable
  • 05:45will be claudication onset time,
  • 05:47in seconds,
  • 05:48during the standard Yale graded
  • 05:49treadmill tests,
  • 05:50and then there's a whole host of
  • 05:53secondary dependent variables including
  • 05:54mean walking distances to mild,
  • 05:56moderate and severe claudication pain.
  • 05:586 minute walking test distances.
  • 06:00Peak systolic velocity through
  • 06:02the popliteal artery.
  • 06:03Average steps per day during
  • 06:05the 12 week home exercise.
  • 06:07Component health related.
  • 06:08Quality of life score.
  • 06:09Walking impairments,
  • 06:10Goran Fear avoidance score.
  • 06:12So this is how it'll work
  • 06:14during the screening.
  • 06:15Visit an ABI.
  • 06:16An ultrasound will be performed
  • 06:18which is just confirming that
  • 06:19they do have peripheral artery
  • 06:21disease and it is in fact,
  • 06:22within their popliteal artery.
  • 06:24They'll fill out this claudication
  • 06:25questionnaire to ensure that
  • 06:27they have true claudication.
  • 06:28Pain will do a history and physical exam,
  • 06:30and then three participants will trial
  • 06:32this graded treadmill test with the image
  • 06:34Ng 'cause this has never been done before,
  • 06:36and we want to make sure we have the proper
  • 06:39technique to make sure it's successful
  • 06:41with the rest of the participants.
  • 06:43Then at this initial visit,
  • 06:45after the screening,
  • 06:46they'll perform this graded treadmill test.
  • 06:48And those who are in the experimental
  • 06:51group will be shown their images
  • 06:54and they'll be explained.
  • 06:56What is going on within their vasculature,
  • 06:59why it's causing the pain and
  • 07:02how exercise will improve their
  • 07:04vasculature and their pain overtime.
  • 07:07Also, fill out three questionnaires,
  • 07:09both groups,
  • 07:09and then they'll be told to go
  • 07:11home and exercise to near maximal
  • 07:13pain three times a week for 45
  • 07:15minutes with increased frequency.
  • 07:17Overtime they'll use a Fitbit only
  • 07:19during exercise sessions to monitor
  • 07:21the steps per day and they will do
  • 07:23this for 12 weeks and then they'll
  • 07:25come back in for a follow up visit.
  • 07:28Well,
  • 07:28they'll do the graded treadmill tests
  • 07:30again and everyone will be showing
  • 07:32their vasculature will repeat the three
  • 07:34questionnaire and they'll be told,
  • 07:35hopefully that they've had improvement
  • 07:37overtime with both their distances.
  • 07:38And within their images.
  • 07:41So what are the strengths,
  • 07:43novelty?
  • 07:44This is the first time this has
  • 07:46been done where we've used images to
  • 07:49increase exercise adherence among the
  • 07:51peripheral artery disease population.
  • 07:53We believe that it addresses 6
  • 07:55reasons for lack of adherence,
  • 07:58which is much better than the than
  • 08:00the supervised and the home exercise
  • 08:03programs that currently exist.
  • 08:04Ultrasound provides a noninvasive,
  • 08:06inexpensive way to show patients the
  • 08:09pathophysiology behind their disease
  • 08:10and give them better understanding.
  • 08:13Lastly,
  • 08:13it allows them to see the impact of
  • 08:15their home exercise at the follow up
  • 08:18appointments and hopefully encourage
  • 08:19them to continue to exercise at home.
  • 08:21The limitations the novelty.
  • 08:22Again anytime you try something new IT
  • 08:25may come with unexpected challenges.
  • 08:26It's not a double blinded study,
  • 08:28but this would be impossible because
  • 08:30we have to show the participants their
  • 08:32images and someone has to do so.
  • 08:34The recruitment process is on
  • 08:36a volunteer basis,
  • 08:37so there is a possibility that
  • 08:38those enrolled in the study will
  • 08:40be more motivated at baseline than
  • 08:42those in the general population.
  • 08:44Lastly,
  • 08:44it may be challenging to motivate
  • 08:46exercise in the winter months,
  • 08:47especially among those who are
  • 08:49low income and do not belong
  • 08:51to exercise facilities.
  • 08:52So what's the clinical significance of this?
  • 08:55The medical community has not been
  • 08:57successful in increasing exercise
  • 08:58adherence among the PD population,
  • 09:00and that's what this study is targeted to do.
  • 09:03The PD prevalence is on the rise
  • 09:05with increasing risk factors,
  • 09:07so we need to find a solution now.
  • 09:10If successful,
  • 09:11this will provide an early intervention
  • 09:13to decrease costly management such
  • 09:15as surgery down the line is an easy
  • 09:17intervention to incorporate into
  • 09:19the diagnostic appointment here at
  • 09:21Yale. They already had
  • 09:22already performed the Abis.
  • 09:23They already do the ultrasound.
  • 09:25They have this graded treadmill
  • 09:27machine within their practice,
  • 09:28so it shouldn't be that big of a
  • 09:30transition to implement this intervention
  • 09:32into the diagnostic appointment.
  • 09:34Ultrasound is cheap, so even outside
  • 09:36the US where the PD prevalence is high,
  • 09:39this may provide an option for them as.
  • 09:42Well and then hopefully it could
  • 09:44be a way to create sustained,
  • 09:46change sustained change even after
  • 09:48the study if they see improvement.
  • 09:51Alright, so I'd like to thank Doctor
  • 09:53Yakel who was the best possible
  • 09:55advisor I could have asked for.
  • 09:57Rosanna and Megan for their support
  • 09:59throughout the entire recess.
  • 10:00Search and thesis process of PA school.
  • 10:03The librarians who answered numerous
  • 10:05technology an resource questions for me.
  • 10:07Throughout the way.
  • 10:08Friends and family.
  • 10:09The class of 2020,
  • 10:10which you can see here an my
  • 10:13big in the program,
  • 10:14Libby has been supportive prior
  • 10:16to PA School all the way through,
  • 10:19even after she's graduated.
  • 10:20So here are my references and thank you guys.