Supervised Exercise

Therapy for Peripheral

Artery Disease (PAD)
American Heart Association
 Diane Treat-Jacobson, PhD, RN,
FSVM, FAHA, FAAN
School of Nursing, University of
Minnesota

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 Financial Disclosures

National Heart Lung and Blood Institute

Margaret A. Cargill Foundation

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 Learning Objectives
• Learn the basics of developing an exercise training
program for patients with symptomatic PAD.

• Learn how to implement an exercise training

program for patients with symptomatic PAD.

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 Exercise Training
in Patients
With PAD

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 Exercise Training in Patients with PAD

• Efficacy of supervised treadmill training

to improve walking distance in patients
with claudication is well established

• Mechanisms by which exercise training

improves walking include both local and
systemic changes

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 Understanding the Physiology of Exercise
Cardiac Output =
HR x stroke volume

7 Keteyian, Ehrman, et al. Advanced exercise physiology: essential concepts and applications p. 74.
 Understanding the Physiology of Exercise
No ischemia/Pain:
Blood/oxygen supply = Oxygen demand

Ischemia/Pain:
Blood/oxygen supply < Oxygen demand

Hiatt & Brass, 2006. Pathophysiology of Intermittent Claudication p. 240. In Vascular Medicine Creager, Dzau, Loscalzo, Eds. Slide courtesy of Jon Ehrman, PhD
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 Pathophysiology of PAD
• PAD-reduced lumen
diameter Endothelial Systemic
Ischemia inflammation
• Reduced blood flow dysfunction
and O2 delivery

Deconditioning & worsening: A Skeletal muscle fiber:

• obesity VICIOUS • denervation
• hypertension • atrophy
• dyslipidemia CYCLE
• altered myosin expression
• hyperglycemia
• thrombotic risk
• Poor aerobic capacity Altered aerobic muscle
metabolism
• Impaired walking • Reduced muscle
ability strength and endurance
• Decreased QoL

X
9 Stewart et al, N Engl J Med 2002; 347: 1941-1951
 Proposed Mechanisms by
Which Exercise May Improve
Function and Symptoms
• Enhanced ATP production
(mitochondrial function)
• Increased muscle strength
• Improved walking economy due to
improved walking biomechanics
• Improved pain threshold/tolerance

10 Stewart et al, N Engl J Med 2002; 347: 1941-1951

 Treadmill Exercise Training for Claudication
There is a wide range of response reported, depending on
training methods and duration, as well as patient population.
Duration of Change in % Change in Change in Peak % Change in
Supervised Claudication Claudication Walking Distance Peak Walking
Program Onset Distance Onset Distance (Meters) Distance
(Meters)
12 weeks (n=8) 156.60 (92–243 m) 103% (54–165%) 283.10 (191–402 m) 79% (42–137%)

24–52 weeks (n=7) 251.23 (155–310 m) 167% (109–230%) 334.06 (212–456 m) 92% (50–131%)

Overall (n=15) 203.93 m 128% 307.45 82%

11 Parmenter, et al, Atherosclerosis, 2011

 Pain-Free Walking Exercise Therapy
• 12-week intervention of treadmill training to onset
of pain—4 studies (Mika, et al. 2005; 2006; 2011; 2013)

• Studies 1–3: (total n=196) resulted in:

‒ Increase in pain-free walking distance of 110% (217 meters)
‒ Increase in peak walking distance of 52% (247 meters)
‒ No increases in inflammatory markers after exercise training (2005)
‒ Erythrocyte deformability was significantly improved only in the
exercise group (2011)
‒ No improvement in control group

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 Pain-Free Walking Exercise Therapy
• Study 4 (2013) compared two treadmill walking protocols (12 weeks):
1. Traditional treadmill walking into moderate to severe discomfort
2. Vs. treadmill walking only to the onset of claudication
‒ Both groups had statistically significant improvement in walking distance
‒ No statistical differences between groups:
Moderate Intensity Group Pain-Free Walking Group
• Improved pain-free walking • Improved pain-free walking
distance 120% (121 meters) distance 93% (141 meters)
• Improved peak walking distance • Improved peak walking distance
100% (393 meters) 98% (465 meters)

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 Lower Extremity Cycling
Investigator Sample Duration Change with Change Change in
Size Leg Cycling with Control
Treadmill
Training
Sanderson, n=42 6 weeks PWD +43m PWD +215m PWD -16m
Askew et al. COD +16m COD +174m COD +49m
2006
Walker, n=67 6 weeks PWD +137m PWD none
Nawaz et al. COD +114m COD none
2000
Zwierska, n=104 24 weeks PWD +31% PWD none
Walker et al. COD +57% COD none
2005

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 Aerobic Upper Body Exercise Therapy for PAD
Investigators From Sheffield, UK
• Series of studies comparing arm ergometry (arm cranking)
versus leg cycling and control (Walker, Nawaz et al. 2000,
n=57; Zwierska, Walker et al. 2005, n=104) or control (Tew,
Nawaz et al. 2009, n=51)
• Exercise training 2x/week; 40-minute sessions; 12–24 weeks
• Outcomes: 50% improvement in PFWD and 30% in MWD
• One study (Tew, Nawaz et al. 2009) found increased time to
minimal STO2 of calf muscle following 12 weeks of arm
exercise

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 Exercise Training for Claudication (ETC) Study
Randomized, controlled pilot study to determine
the relative efficacy of 12 weeks of 3x/week
supervised treadmill training or arm ergometry
alone, or in combination, versus ‘usual care’ in
patients with claudication
• Claudication onset distance after 12 weeks exercise training:
AE=+133m (82%); TM= +91.6m (54%); Combo= +62m (60%)
• Peak walking distance after 12 weeks of exercise training:
AE=+182m (53%); TM= +295m (69%); Combo= +217m (68%)
• No improvement in control subjects

16 Treat-Jacobson, Bronas et al. 2009

 CLEVER:
Supervised Exercise Versus Iliac Artery Stenting
Change from Baseline to Six (6) Months and 18 months

Peak Walking Time Claudication Onset Time

19 Murphy, T.P. et al. J Am Coll Cardiol. 2015; 65(10):999-1009

 CLEVER: Cost Effectiveness

Pre-planned analysis of cost effectiveness of

supervised exercise (SE) stenting, and optimal
medical care (OMC) for claudication
• Incremental cost effectiveness ratios (ICERS)
̶ $24,070 per quality adjusted life year gained for SE vs OMC
̶ $41,376 per quality adjusted life year gained for Stent vs OMC
̶ $122,600 per quality adjusted life year gained for Stent vs SE

20 Reynolds, et al., JAHA, 2014; 3:e001233

 CLEVER: Cost Effectiveness

“Given the increased expense and marginal

benefits of ST relative to SE, there would appear
to be no rational justification for covering ST but
not SE for the treatment of claudication.”
(Reynolds, et al. p. 8)

21 Reynolds, et al., JAHA, 2014; 3:e001233

 Supervised Exercise Rehabilitation
COR LOE Recommendations
In patients with claudication, a supervised exercise program
COR-Class
(strength) of I A is recommended to improve functional status and QoL and
recommendation to reduce leg symptoms.
A supervised exercise program should be discussed as a
LOE-Level treatment option for claudication before possible
I B-R
(quality) of
revascularization.
evidence
In patients with PAD, a structured community- or home-
based exercise program with behavioral change techniques
IIa A can be beneficial to improve walking ability and functional
status.
In patients with claudication, alternative strategies of
exercise therapy, including upper-body ergometry, cycling,
IIa A and pain-free or low-intensity walking that avoids
moderate-to-maximum claudication while walking, can be
beneficial to improve walking ability and functional status.

22 Gerhard-Herman M, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease. Circulation. 2016;69(11) :1465-1508.
 2016 PAD Guideline Definitions
Structured exercise program
• Planned program that provides individualized recommendations for type, frequency, intensity, and
duration of exercise.
• Program provides recommendations for exercise progression to assure that the body is consistently
challenged to increase exercise intensity and levels as functional status improves over time.

Supervised exercise program

• Program takes place in a hospital or outpatient facility.
• Program uses intermittent walking exercise as the treatment modality.
• Program can be standalone or within a cardiac rehabilitation program.
• Program is directly supervised by qualified healthcare provider(s).
• Training is performed for a minimum of 30–45 minutes/session; sessions are performed
at least 3 times/week for a minimum of 12 weeks.
• Training involves intermittent bouts of walking to moderate-to-maximum
claudication, alternating with periods of rest.
• Warm-up and cool-down periods precede and follow each session of walking.

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 2016 PAD Guideline Definitions
Structured community- or home-based exercise program
• Program takes place in the personal setting of the patient rather than in a clinical setting.
• Program is self-directed with guidance of healthcare providers.
• Healthcare providers prescribe an exercise regimen similar to that of a supervised program.
• Patient counseling ensures understanding of how to begin and maintain the program and how
to progress the difficulty of the walking (by increasing distance or speed).
• Program may incorporate behavioral change techniques, such as health coaching or use of
activity monitors.

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 CMS Coverage Language for SET
for Treatment of Symptomatic PAD
• 3-1-2017: “The Centers for Medicare & Medicaid Services (CMS) proposes that the evidence is
sufficient to cover supervised exercise therapy (SET) for beneficiaries with intermittent
claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD).”
• A SET program must include:
̶ Three sessions per week
̶ Sessions lasting 30–60 minutes comprised
of a therapeutic exercise-training program ̶ Up to 12 weeks of sessions
for PAD in patients with claudication ̶ (CPT code: 93668)
• CMS proposes that Medicare Administrative Contractors (MACs) have the discretion to cover SET
beyond 36 sessions over 12 weeks and may cover an additional 36 sessions over an extended
period of time with a new referral if patients continue to be symptomatic.

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 Reimbursement
CPT code: 93668

Payment: for 2018 for on-campus hospital outpatient setting ~$55 per session; recall patient
pays for 20% or approximately $11 per session

ICD10 Codes:
I73.9 Peripheral vascular disease, unspecified
I70.20 Unspecified atherosclerosis of native arteries of extremities
I70.21 Atherosclerosis of native arteries of extremities w/intermittent claudication
I70.22 Atherosclerosis of native arteries of extremities w/rest pain
(-) Add 6th character
1 – right leg 2 – left leg 3 – bilateral legs

NOTE: Always check with your Medicare Administrative Contractor (MAC) for specifics.

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 Our Experience
• Two projects that have informed implementation of SET for
PAD
• PAD PRAIRIE Initiative
̶ Implementing SET for PAD in communities in rural Minnesota

• Clinical implementation of SET for PAD throughout the Fairview

cardiac rehabilitation centers in the Twin Cities Metropolitan
area
• This has allowed us to see the “real world” implications of an
implementation of a clinical PAD exercise program.

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 Elements Needed
Develop Programmatic Infrastructure
• Identify medical director.
• Establish referral process. Make providers aware of
availability SET for PAD.
̶ May need changes to electronic health record
• Train cardiac rehabilitation staff about how to implement
SET for PAD.
• Develop implementation process.

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 Baseline Assessment
• Functional evaluation
̶ Graded Exercise Test (Gardner; Hiatt; Bronas/Treat-Jacobson)
• Peak walking time or distance (PWT/D); claudication onset time or distance
(COT/D)
̶ 6-minute walk test
̶ Short Physical Performance Battery
̶ Timed Up and Go (TUG) Test

• Subjective assessment
̶ Walking Impairment Questionnaire
̶ Quality of life (PADQOL, VASCUQOL, PAQ)
̶ Functional status (SF-36, PROMIS)

• Orient patient to exercise equipment

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 Peripheral Artery Disease
Supervised Exercise Therapy Evaluation
Client Name: MR#: CSN#:

Date: DOB/Age: Diagnosis:

Medical History (check all that apply and explain) Risk Factors for CAD (check all that apply)

 Heart  Other  Weight  Exercise

 Lung
 Stress  HTN
 Stroke
 Cholesterol  DM
 Depression
 Orthopedic  Family Hx  Depression

Pain Screen: Stress test results (if available):

Intensity Rating: Max HR:
Location: Onset: 85% of max HR:
Duration of ea. Episode: Onset of Claudication: minutes
Precipitating Factors: Peak MET Level:
Alleviating Factors:

Wounds Present: ABIs:

Do you have any wounds on your feet? Yes No Right Pre Ex: Post Ex:
Location of wounds: Left Pre Ex: Post Ex:
Do you know how to do a foot inspection? Yes No Symptoms of Claudication:
Handout provided? Yes No Location of Claudication:
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 Peripheral Artery Disease
Supervised Exercise Therapy Evaluation
6-Minute Walk Test: Initial Date: Discharge Date:
Total Time Walked
Resting Heart Rate (bpm)
Exercise Heart Rate
Recovery Heart Rate
Resting Blood Pressure (mm Hg)
Exercise Blood Pressure
Recovery Blood Pressure
Claudication Onset Time (COT)
Claudication Onset Distance (COD)
Total Distance Walked (PWD)
Effort Rating (OMNI Scale)
O2 Saturation

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 Peripheral Artery Disease
Supervised Exercise Therapy Evaluation
Client Name: MR#: CSN#:

FALLS SCREEN (Circle one)

Have you fallen two or more times in the past year? Yes No Have you fallen and had an injury in the past year? Yes No
Referral to Physical Therapy? Yes No

Outcomes: Initial Discharge

MET level (6 MWT): MET level (6 MWT):
MET level (treadmill): MET level (treadmill):
st nd
TUG Test: 1 : 2 : TUG Test: 1st: 2nd:

Initial MET level (treadmill) is based on third visit. Discharge MET level (treadmill) is based on peak METs achieved at end of program.
Goals:
1. 2.

Initial Session: Comments:

Discharge Summary: Goals MET: Yes No Comments:

Evaluation Therapist Signature: Date: Time:

Discharging Therapist Signature: Date: Time: d

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 Treadmill Walking Exercise
• Considered the gold standard for exercise
therapy for PAD
̶ Initial prescription (speed and grade of
treadmill) is determined by baseline functional
testing
̶ Perform a treadmill familiarization to allow the
patient to determine preferred walking speed
̶ Training sessions consist of intermittent bouts
of walking/resting based on claudication level
̶ Use claudication scale to determine
exercise/rest cycles

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 Claudication Pain Scale
0 = no pain Resting or early exercise effort

1 = mild pain 1st feeling of any pain in legs

Pain level at which exercise

2 = moderate pain training should cease

3 = intense pain Nearly maximal pain

4 = unbearable pain Most severe pain experienced

34 ACSM Guidelines for Exercise Testing and Prescription, 2017

 Claudication Pain Scale
0 = no pain Resting or early exercise effort

1 = onset of pain 1st feeling of any pain in legs

2 = mild pain
3 = moderate pain
Where patient needs to stop
during exercise training
4 = moderate pain
5 = severe pain
Stop before you have severe pain.
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 Treadmill Walking Exercise
Intensity and Time
• Begin at initial speed/grade that brings on
claudication within 2–5 minutes.
• Walk to bring on claudication.
̶ Make progressive increases in walking time.
̶ Stop and sit when you reach moderate intensity pain.
̶ Resume when pain has completely subsided.
̶ Continually repeat process for total time
(walking + resting) of 30–60 minutes.
• Make progressive increases in grade
and speed over time as walking
duration improves.
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 Peripheral Artery Disease Supervised Exercise Therapy
Daily Progress Note
Diagnosis:

Date: / Session #: Blood Sugar: Pre: Post:

OMNI OTHER
MODALITY SPEED GRADE TIME ONSET OF PAIN PAIN (0-5 SCALE) EFFORT REST TIME WORKLOAD

Resting Heart Rate: Exercise Heart Rate: Resting Blood Pressure:____________

Exercise Blood Pressure: Total Exercise Time: Total Rest Time: Total Session Time:
Symptoms Beyond Claudication Pain: Home Exercise:
Assessment/Progress: Plan:
Signature: Date: Time:

546345 Rev 8/17 Progress Note/Clinic Note Original: Medical Record Page 1 of 2

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 Treadmill Protocol
Session 1: Choose a comfortable walking speed and adjust grade as needed to induce a 3–4/5 claudication
within 5–10 minutes. Have participant rest until pain dissipates. Repeat intervals 60 minutes as tolerated.

Session 2: Repeat session 1 exercise prescription

If able to walk continuously for 8–10 minutes or

If not able to walk continuously for 8–10 minutes
more

Increase grade by 1% Continue at the same intensity

Continue progression scheme until participant is able to walk continuously for

8–10 minutes at a grade of 10%; increase by 0.1 mph next session

If patient able to walk continuously for 8–10 minutes at more

If not able to walk continuously for 8–10 minutes
than 3.0 mph and 10% grade

Increase grade by 1% Continue at the same speed and grade

NEXT SESSION

If able to walk at 15% grade and 3.0 mph, continue increasing mph by 0.1 mph each time individual is able to walk
continuously for 8–10 minutes NEXT SESSION
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 SET for PAD in the “Real World”
• Most PAD exercise trials have compared treadmill
exercise to another condition (procedure, alternative
exercise, control).
• Patients needed to be able to walk on a treadmill at 2
mph, otherwise they were excluded.
• We have found that many PAD patients are not willing
or able to walk on a treadmill (balance, discomfort).
• Number of treadmills may be limited.
• Alternative forms of exercise should be considered.

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 SET for PAD in the “Real World”
• Try treadmill or other walking exercise first.
• If unable to perform treadmill exercise or if walking
duration is so short that benefit is unlikely, consider
alternative mode:
̶ Seated aerobic arm exercise
̶ Recumbent total body stepping (NuStep)
̶ Lower extremity cycling

• Encourage the exercise therapists to apply their art and

science as they do with cardiac rehabilitation.

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 PAD PRAIRIE Initiative
Arm Ergometry Protocol
Session 1–6: Initiate UBE-EX at 50–60 rpm; adjust ergometer resistance to
promote moderate exertion (RPE 12–13). UBE-EX performed at intervals of
2:2 for entirety of 60-minute session

Session 7–12: Progress UBE-EX by increasing work/rest ratio to 3:2; adjust

resistance to promote moderate intensity (RPE 12–13)

Session 13–30: Progress UBE-EX by gradually increasing work/rest ratios

from 3:2 to 5:1 over several weeks. Adjust resistance to promote moderate
to vigorous intensity (RPE 13–14)

Session 31: Progress UBE-EX by increasing work/rest ratio to 5:1 adjust

resistance to promote vigorous intensity (RPE 14–15)

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 PAD PRAIRIE Initiative
Total Body Recumbent Stepping Protocol
Session 1: Determine comfortable step rate (50–80 steps per minute), adjust resistance
(level) that induces 3–4/5 claudication within 5–10 minutes. Have participant rest until
pain dissipates. Repeat intervals for entirety of 60-minute session.

Session 2: Repeat session 1 exercise prescription

If patient is able to exercise continuously If patient is not able to exercise continuously

for 8–10 minutes for 8–10 minutes

Progress workload by 1 level Continue at same intensity

If patient is able to exercise at workload (level) 10 continuously for 8–10

minutes, increase pace (steps per minute) by 10

If patient is able to exercise continuously for If patient is not able to exercise continuously
8–10 minutes for 8–10 minutes

Progress workload by 1 level Continue at same intensity

If patient is able to exercise at workload (level) 20 continuously for 8–10

minutes, maintain intensity for remainder of program
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 Where to put a chair?

Someone took
my treadmill!!

43 Courtesy of Jon Ehrman, PhD

 Safety Considerations
• Potential to unmask new angina due to increased
exercise capability
̶ Follow up on new signs and symptoms of
coronary disease

• Abrupt increase in claudication symptoms could

signal worsening of lower extremity arterial disease
̶ Evaluate for deterioration in limb blood flow

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 Safety Considerations

Assess legs and feet for indications

of critical limb ischemia.
• Ask patient about sores or pain.
• If known open sore or pain, assess more
often.
• Evaluate skin: color, hair, shiny, thin,
fragile.

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 Critical Limb Ischemia
Dependent rubor Elevation pallor

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 Collecting Outcome Data
• Not a CMS requirement, but part of “Best Practices”
for Cardiac Rehabilitation
• Collect same measurements as at baseline
• Functional
̶ Change in walking speed and grade
̶ 6 MWT
̶ Graded treadmill test to assess for pain-free and peak
walking time
̶ PROMIS or SF-36 questionnaire
̶ WIQ (Walking Impairment Questionnaire)
• Quality of Life
̶ PADQOL
̶ VASCUQOL

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 Resources
• Intake and progress forms being finalized and can be adapted
• PAD PRAIRIE website https://www.nursing.umn.edu/research/research-projects/pad-
prairie/resources-providers and videos available
̶ Functional Assessment testing
• 6-minute walk test
• Timed Up and Go Test (TUG)
• Short Physical Performance Battery
̶ How to initiate progress a patient in supervised treadmill exercise and aerobic
arm exercise
• Updated PAD Rehabilitation Toolkit available at no charge on AACVPR website
• AHA commissioned a Science Advisory “How to Implement Supervised Exercise
Therapy for Patients With Symptomatic Peripheral Artery Disease,” which should be
completed in the next six months.

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