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

NCT07637396 | Not Yet Recruiting

• 1 other identifier: STUDY00003226
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Peripheral Arterial Disease(PAD)

Keywords

peripheral arterial disease; ankle brachial index; doppler ultrasound

Outcome Measures

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.

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

Secondary Outcomes (8)

• Short-Form 36 (SF-36)

  prior to baseline ABI testing

• International Physical Activity Questionnaire (IPAQ)

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

• Gait speed

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

• Time to first standing rest break

  1time during 6MWT

• Total duration of all standing rest breaks

  1 time during 6MWT

Study Arms (1)

study participants

baseline ABI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• self-reported inability to walk for 6 minutes
• severe cardiac or pulmonary disease limiting exercise
• inability to obtain a Dopplerable pulse
• noncompressible arteries (ABI \>1.4)
• those unable to consent

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

LSU Health Shreveport

Shreveport, Louisiana, 71130, United States

Location

Related Publications (5)

• Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.

  PMID: 11454114 BACKGROUND

• Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e686-e725. doi: 10.1161/CIR.0000000000000470. Epub 2016 Nov 13.

  PMID: 27840332 BACKGROUND

• Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FG, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RA, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Mar 21;135(12):e726-e779. doi: 10.1161/CIR.0000000000000471. Epub 2016 Nov 13.

  PMID: 27840333 BACKGROUND

• McDermott MM, Tian L, Liu K, Guralnik JM, Ferrucci L, Tan J, Pearce WH, Schneider JR, Criqui MH. Prognostic value of functional performance for mortality in patients with peripheral artery disease. J Am Coll Cardiol. 2008 Apr 15;51(15):1482-9. doi: 10.1016/j.jacc.2007.12.034.

  PMID: 18402904 BACKGROUND

• Parmenter BJ, Dieberg G, Smart NA. Exercise training for management of peripheral arterial disease: a systematic review and meta-analysis. Sports Med. 2015 Feb;45(2):231-44. doi: 10.1007/s40279-014-0261-z.

  PMID: 25230780 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Sarah Murnane, PT, DPT, PhD(c)

CONTACT

318-813-2980; sarah.murnane@lsuhs.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

US (1)