Skip to main content
. 2023 Aug 29;12(17):e031182. doi: 10.1161/JAHA.123.031182

Table 2.

Inclusion and Exclusion Criteria

Inclusion criteria Rationale
  • Presence of PAD, defined by:
    • ABI ≤0.90 or TBI ≤0.70 at baseline visit
    • ABI >0.90 and ≤1.00 with a 20% or greater drop in ABI in either leg after the heel‐rise test at baseline visit
    • ABI >0.90 at baseline visit with vascular laboratory evidence or angiographic evidence of PAD, including:
      • TBI ≤0.70
      • Duplex ultrasound or angiographic evidence of ≥70% stenosis in lower extremity artery
      • Post heel‐rise or post‐exercise ABI drop in either leg of ≥20%
      • ABI ≤0.90
    • Individuals with a history of lower extremity revascularization who do not meet the criteria above and have an ABI >0.90 with ≥20% drop in ABI after an exercise test will be eligible if they have symptomatic PAD*

Accepted criteria for PAD in clinical practice guidelines. 3

  • BMI ≥25 kg/m2

Overweight and obesity are defined as a BMI of 25–29 kg/m2 and >30 kg/m2. Observational evidence demonstrated a linear trend in association of normal BMI, overweight, and obesity with the magnitude of annual decline in 6‐minute walk distance among people with PAD. 4
  • Age ≥18 years

PAD is rare in children
Exclusion criteria Rationale
  • Above or below knee amputation, critical limb ischemia, or wheelchair confinement.

These criteria characterize severe or end stage PAD. Most individuals with PAD do not have severe/end stage PAD.
  • Walking is limited by a condition other than PAD.

The WL+EX intervention is designed to improve walking impairment caused by PAD.
  • Failure to complete the study run‐in defined as not entering at least 800 kcal of consumed calories per day for at least 5 days during the 7‐day run‐in

These individuals may not adhere to study

requirements.

  • Major surgery, coronary or leg revascularization in the past 3 months or anticipated in the next year.

These procedures may influence functional performance, independent of study interventions.

  • Experienced a heart attack or stroke in the past 3 months.

  • Major medical illness including lung disease requiring oxygen, Parkinson disease, a life‐threatening illness with life expectancy <6 months, or cancer requiring treatment in the previous 2 years.

  • Increase in angina or angina at rest. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.

  • Current ulcer on bottom of foot

These conditions may interfere with the ability to fully participate in and complete the study.
  • Mini‐Mental Status Examination score <23, dementia, and substance abuse.

  • History of being treated for new onset or an acute episode of schizophrenia or psychosis in the past 6 months.

  • Hospitalization for a psychiatric disorder in the past 6 months.

May interfere with ability to fully adhere to the study intervention or accurately complete questionnaires.
  • BMI >45 kg/m2

These individuals have morbid obesity that requires more intensive treatment than our intervention provides.
  • History of a significant eating disorder that has been active within the past 5 years or weight loss treatment in the past 6 months. Weight loss treatment includes Weight Watchers, any history of weight loss surgery, and using weight loss medications now or in the past 6 months.

  • Weight gain or loss of >25 pounds in the past 6 months

The WL+EX intervention is not intended for individuals with an eating disorder. Patients with recent weight loss may have weight change independently of the study interventions.
  • Unwilling/unable to use a smartphone and unwilling to attend weekly study sessions.

  • Non‐English‐speaking

  • Visual impairment that limits walking ability

These individuals will not be able to fully engage in the intervention.
  • Excessive alcohol use, defined as >14 drinks/wk in men and >10 alcoholic drinks/wk in women.

These individuals may not be able to lose weight.
  • Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention

  • Current participation in supervised treadmill exercise, participation in supervised treadmill exercise in the past 3 months or planning to participate in supervised treadmill exercise in the next year.

  • Participation in or completion of a clinical trial in the previous 3 months §

These programs may influence functional performance, independent of study interventions.

ABI indicates ankle brachial index; BMI, body mass index; PAD, peripheral artery disease; TBI, toe brachial index; and WL+EX, weight loss plus exercise.

*

Symptomatic PAD will be defined as leg symptoms associated with exertion that resolved within 10 minutes of rest. The presence of symptomatic PAD will be determined based on the claudication questionnaire, the 6‐minute walk, or principal investigator interview/discussion with the potential participant.

The run‐in period can be extended to assist participants with learning the app, but participants must demonstrate ability to enter at least 800 kcal per day for at least 5 days of the run‐in period.

Potential participants may still qualify if they have had treatment for an early‐stage cancer in the past 2 years and the prognosis is excellent.

§

After completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow‐up visit of the stem cell or gene therapy study so long as at least 6 months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow‐up visit provided at least 3 months have passed since the final intervention of the trial.