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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLouisiana State University Health Sciences Center Shreveport

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

individuals over 65 years of age

individuals aged 50-64 with a risk factor for atherosclerosis including diabetes mellitus, history of smoking, hyperlipidemia, hypertension, or family history of peripheral arterial disease (PAD)

individuals aged 18-50 with diabetes mellitus and one additional risk factor for atherosclerosis as noted above, or

individuals with known atherosclerotic disease in another vascular bed including the coronary, carotid, subclavian, renal, or mesenteric artery stenosis, and individuals with known PAD

Disqualifiers

contraindications to brachial and/or ankle pressure measurement including history of deep vein thrombosis

lymphedema of the arms or legs

history of mastectomy or current leg ulceration preventing placement of a blood pressure cuff around the lower leg

an inability to lie in a supine position for 15 min

Trial population

recruited from local outpatient rehabilitation, vascular, and internal medicine clinics

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

85 Participants
are grouped into 1 trial group
Group A: study participants

Trial outcomes

Primary outcomes

1

magnitude of ABI reduction

Measured as both absolute and percent change, calculated as the difference between baseline ABI and ABI immediately after exercise, at 1-, 3-, and 5-minute recovery intervals.

Time frame
immediately after exercise, at 1-, 3-, and 5-minute recovery intervals.

Secondary outcomes

1

Short-Form 36 (SF-36)

A generic outcome survey to quantify health status and health-related quality of life over 8 health domains. Minimum possible score is 0 and maximum possible score is 100. A higher score indicates better health condition, complete functioning, or absence of limitations.

Time frame
prior to baseline ABI testing
2

International Physical Activity Questionnaire (IPAQ)

The IPAQ classifies individuals into low/moderate/high activity levels based on their subjective report of frequency, duration, and intensity of walking, moderate, and vigorous activity. Scoring for the IPAQ places individuals into a level based on their categorical score: Low Those who not meet criteria for categories 2 or 3 are considered low/inactive. Moderate Any one of the following three criteria: * 3 or more days of vigorous activity of at least 20 minutes per day OR * 5 or more days of moderate-intensity activity or walking of at least 30 min per day OR * 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week. High Any one of the following two criteria: * Vigorous-intensity activity on at least 3 days and accumulate at least 1500 MET-min/week OR * 7 or more days of any combo of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-min/week

Time frame
3 times including at rest prior to 6MWT, at minute 3 and again at minute 6 during 6MWT
3

Gait speed

Gait speed is measured as the time taken to walk a fixed distance of 4-meters measured in meters per second (m/s) taken at a set time during the 6MWT.

Time frame
gait speed between minute 0-1, minute 3-4, and minute 5-6 of 6MWT
4

Time to first standing rest break

The time until the participant takes their first standing rest break during the 6MWT, measured in seconds (s)

Time frame
1time during 6MWT

Other outcomes

Sponsors and contacts

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