Ankle-Brachial Index Changes Post Exercise and Its Effects on Patient-Centered Outcomes and Gait

Overview

The goal of this observational study or clinical trial is to investigate how exercise can affect different areas of a person's life, especially those people with vascular disease. This is important because exercise can be beneficial for people with vascular disease. The study could include any of the following: those aged 65 years of age and older, between the ages of 50-64 who smokes, has diabetes, high blood pressure, high cholesterol, or has a family member with vascular disease, between the ages of 18-49 with diabetes and one other factor listed above, or those with vascular disease. The main question\[s\] it aims to answer is if exercise testing can better predict vascular disease. The following research questions will be addressed in this study: 1. Does baseline ABI influence the magnitude and recovery trajectory of ABI following an acute bout of exercise across a spectrum of vascular function? 2. What association does exercise-induced ABI changes have on patient-reported outcomes of quality of life and intermittent claudication? 3. Do functional outcomes of gait speed, time to claudication, gait variables related to rest breaks in 6MWT, and walking distance predict the magnitude of exercise-induced ABI reduction? Participants will : * complete various questionnaires and a routine screening for vascular disease \*walk for 6 minutes at your own pace * additional vascular screening tests will be performed.

The purpose of this study is to examine if dynamic, exercise induced changes in the ankle- brachial index (ABI) are associated with pain, quality of life, and functional outcomes to better characterize peripheral vascular disease. Individuals will be screened for eligibility if they meet the inclusion criteria. All data collection will occur during a single laboratory visit. It is anticipated the research study will take 1-2 hours, with 1 visit total to complete the study. The primary study endpoint is to assess the use of the ankle-brachial test after exercise. This will be accomplished when the proposed number of subjects have been enrolled and completed the proposed protocol. Secondarily, the study may be stopped due to lack of funding. The final endpoint will be the completion of all data analysis including long-term follow up data and preparation for dissemination of the research findings. The primary safety endpoint will occur if the study participant is unable to complete any part of the protocol. All participants will give written consent to participate in the study. Participants will be instructed to refrain from alcohol, caffeine, nicotine, and exercise for at least one hour prior to testing to minimize confounding physiological effects. Testing will occur in a temperature-controlled environment maintained between 74-78°F (23-26°C) to ensure thermal stability and vascular consistency. Participant information including age, body mass index (BMI), diabetes status, past medical history, smoking history, and a list of current medications will be collected. Participants will be comfortably positioned supine with the head of bed flat and legs fully extended. A 10-minute rest period will precede the initial ABI test to allow for hemodynamic stabilization. For all ABI measurements, systolic blood pressures will be measured at the brachial and dorsalis pedis or posterior tibial arteries in both lower extremities using a hand-held 8-10 MHz continuous wave Doppler ultrasound probe (Huntleigh or equivalent) and appropriately sized sphygmomanometer cuffs. See Appendix A for ABI procedure details. The order of arterial site measurements for initial resting ABI will be determined using a computer-generated randomization schedule. The limb exhibiting the lowest resting ABI will be selected for inclusion in the statistical analysis. The ABI will be calculated as the ratio of the higher ankle systolic pressure (either dorsalis pedis or posterior tibial) to the higher brachial systolic pressure (left or right arm). All data will be recorded to the nearest 2 mmHg. Participants will then complete a 6-minute walk test, up to max pain on the 1 to 5 Claudication Symptom Rating Scale, to elicit claudication symptoms. ABI immediately post-exercise and at 1-, 3-, and 5-minute recovery intervals will be assessed in the same position as the resting ABI. A participant will be considered to have completed the study after participating in the single visit. No in person follow up visits are anticipated. Demographic history and SF-36 questionnaire may be collected by phone if needed. Participation in this study is completely voluntary, and subjects can withdraw at any time. No specimens are associated with this study. All data will be stored according to study and subject number on an LSU network server. Electronic data and analysis will be retained for a minimum of seven years after study closure, and indefinitely after that. Standard research practices will be used to document informed consent and schedule study visits. Consented subjects will be assigned a study number. A subject log relating subject name and subject number will be maintained by study personnel on a secure computer workstation by Dr Murnane in the School of Health Professions. Original signed and dated documents for all subjects will be securely maintained in the School of Health Professions. A research team member will contact and discuss the study with potential participants to assess his/her interest in participating. The study design outlines methods of ensuring ongoing consent. Formal consent and signing of the consent form will occur in the School of Allied Health Professions or vascular clinic at Ochsner LSU Health Shreveport with a member of the study team before any testing begins. Subjects will have the opportunity to ask questions and decline participation in this study. A copy of the informed consent will be provided to the subject.