Clinical setting. This retrospective, observational study was performed at the Daemen College Physical Therapy Wound Care Clinic (Cheektowaga, NY). The study protocol was approved with an exemption by the Daemen College Institutional Review Board. Established in 2012 as a result of grants from private philanthropic organizations, this clinic has been operating as an outpatient physical therapy clinic specializing in wound care and serving the western New York community. The clinic is located with a physician’s office (operating as separate entities), and physical therapists consult with the physician when needed during wound care. All patients with a few exceptions are referred from and follow up with this physician who is an infectious disease expert. In addition to routine physical therapy wound care (ie, wound debridement, infection control, dressing application, electric stimulation, ultrasound, ultraviolet therapy), various forms of exercise are routinely prescribed for all patients, including range of motion, strengthening exercises, and endurance activities (eg, walking, stationary cycling, upper body ergometry). Physical therapists and researchers at the clinic have been tracking patient demographics and wound-related history using a deidentified electronic medical database since the opening of the clinic. Starting in August 2016, in addition to routine evaluation measures, each patient was screened upon initial evaluation by a physical therapist for cardiovascular risk according to the American College of Sports Medicine (ACSM) guidelines.12
Screening procedure. At the time of initial physical therapy evaluation, patient demographics and wound history were summarized and described, including the type of wound, duration of the wound, and whether pain was associated with the wound. Pain was assessed on an 11-point numeric pain rating scale, where 0 = no pain and 10 = worst possible pain. Patients reporting 0 were deemed to have no pain associated with the wound; patients reporting between 1 and 10 were deemed to have pain associated with the wound. Pain scores were not tracked; they were used only to determine if the patient had pain associated with the wound. As such, pain severity results were not reported.
Wounds then were classified by the physical therapist as either venous leg ulcers or nonvenous leg ulcers, based upon the referring physician’s diagnosis.13,14 After the physical therapist was trained and appropriately familiarized with the protocol, each patient was screened upon initial evaluation by a single physical therapist for cardiovascular risk according to the ACSM guidelines.12 The screening process entails assessment of current signs and symptoms of cardiovascular, pulmonary, or metabolic disease; an individual or family history of cardiovascular disease; whether the patient is considered obese; and whether the patient is a current smoker or has a sedentary lifestyle, dyslipidemia, elevated glucose, or blood pressure >140/90 mm Hg. Operational definitions for each of the risk factors are presented in Table 1.6,7,12
Methods. Study participants had been referred to a physical therapist at the Daemen College Physical Therapy Wound Care Clinic for the treatment of an integumentary disorder over a 9-month period (August 1, 2016, to May 1, 2017). In this study, all patients at least 21 years of age with wounds who had patient demographic, wound history, and ACSM variables appropriately recorded in the electronic medical database were eligible for study inclusion. Exclusion criteria included patients <21 years of age and a sufficient lack of variables recorded in the electronic medical database.
Data collection. Data were anonymously entered on a standardized paper-and-pencil data collection sheet from the deidentified patient electronic medical database and subsequently entered into a password-protected electronic spreadsheet. Patients then were stratified as being at low risk, moderate risk, or high risk for experiencing a future cardiovascular event according to the ACSM guidelines.12 More specifically, low risk is described as men <45 years old, women <55 years old, and only 1 risk factor and no symptoms; moderate risk is described as men >45 years old, women >55 years old, or 2 or more risk factors; and high risk is described as known cardiovascular, pulmonary, or metabolic disease or signs and symptoms of cardiovascular disease, including chest pain, shortness of breath at rest or mild exertion, syncope, ankle edema, and palpitations. Medical clearance is recommended for individuals who will be performing exercise if they are stratified as moderate or high risk of experiencing a future cardiovascular event.
The ACSM guidelines12 for establishing cardiovascular risk have previously been recommended and utilized as a pragmatic method for exercise decision making and medical clearance in outpatient or community-based physical therapy settings6,7; these guidelines12 have been reported on extensively in various populations and appear generally to have face validity.15-18 Additionally, although the components that are evaluated in the ACSM guidelines are generally consistent with other cardiovascular risk guidelines and calculators and a part of sound, routine history and physical examination procedures (eg, evaluating smoking status, diabetic status, exercise habits, blood pressure measures, lipid profile, and BMI), the authors were unable to find research that has formally studied the reliability and validity of the guidelines. However, several studies that have evaluated other similar cardiovascular risk guidelines and calculators (eg, Framingham Risk Score,19-22 American College of Cardiology/American Heart Association Guidelines,23 algorithm for calculating cardiovascular disease risk [QRISK],24 and Reynolds Risk Score25) have demonstrated good construct validity and internal consistency, as well as high levels of reliability and responsiveness. Thus, in accordance with other authors, the current authors concluded ACSM guidelines for establishing cardiovascular risk are appropriate for clinical and research purposes.6,7,15-18
Data analysis. Statistical analyses were performed using SPSS, version 23.0 (IBM Corporation, Armonk, NY), including calculation of descriptive statistics (ie, means, standard deviations, ranges) and frequency distributions to assess the prevalence of individual cardiovascular risk factors, total number of cardiovascular risk factors, cardiovascular risk stratification, and patient disposition. Frequencies of individual cardiovascular risk factors, total number of cardiovascular risk factors, and cardiovascular risk stratification also were assessed between patients with venous leg ulcers and nonvenous leg ulcers using chi-square tests for categorical data and t tests for continuous data. The alpha level was set at P <.05.