Peripheral Arterial Disease(PAD)ExerciseABINCT07637396
Ankle-Brachial Index Changes Post Exercise and Its Effects on Patient-Centered Outcomes and Gait
An observational study of Peripheral Arterial Disease(PAD), run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease(PAD)
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: recruited from local outpatient rehabilitation, vascular, and internal medicine clinics
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- inability to obtain a Dopplerable pulse
- noncompressible arteries (ABI >1.4)
- those unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
LSU Health Shreveport
Shreveport, Louisiana, 71130
Sarah Murnane, PT, DPT, PhD(c), 318-813-2980, sarah.murnane@lsuhs.edu
Sarah Murnane, PT, DPT, PhD(c)
About this study
Official title: Exercise-Induced Ankle-Brachial Index Dynamics as a Predictive Marker in Peripheral Arterial Disease
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:
Read more
- Does baseline ABI influence the magnitude and recovery trajectory of ABI following an acute bout of exercise across a spectrum of vascular function?
- What association does exercise-induced ABI changes have on patient-reported outcomes of quality of life and intermittent claudication?
- 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.
Read the detailed description
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.
- Conditions
- Peripheral Arterial Disease(PAD)
- Keywords
- peripheral arterial disease, ankle brachial index, doppler ultrasound
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study participants | baseline ABI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after exercise, at 1-, 3-, and 5-minute recovery intervals.
Secondary outcomes (8)
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.
Measured: prior to baseline ABI testing
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
Measured: 3 times including at rest prior to 6MWT, at minute 3 and again at minute 6 during 6MWT
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.
Measured: gait speed between minute 0-1, minute 3-4, and minute 5-6 of 6MWT
Time to first standing rest break
The time until the participant takes their first standing rest break during the 6MWT, measured in seconds (s)
Measured: 1time during 6MWT
Total duration of all standing rest breaks
The total time duration, measured in seconds, of all standing rest breaks taken by the participant during the 6MWT.
Measured: 1 time during 6MWT
Number of standing rest breaks
The number of standing rest breaks taken by a participant during the 6MWT.
Measured: 1 time during the 6MWT
First standing rest break
The distance to first standing rest break, measured in meters (m), during the 6MWT.
Measured: During the 6MWT
Total walking distance
The total walking distance prior to participant sitting down during the 6MWT, measured in meters (m).
Measured: 1 time during the 6MWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637396
- Sponsor's protocol ID
- STUDY00003226
- Acronym
- ExerciseABI
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Would need to explore institutional requirements
Publications
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.
PubMed 11454114Gerhard-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.
PubMed 27840332Gerhard-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.
PubMed 27840333McDermott 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.
PubMed 18402904Parmenter 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.
PubMed 25230780
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-Induced Ankle-Brachial Index Dynamics as a Predictive Marker in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT07637396
- Acronym / sponsor ID
- ExerciseABI / STUDY00003226
- Conditions
- Peripheral Arterial Disease(PAD)
- Keywords
- peripheral arterial disease, ankle brachial index, doppler ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does baseline ABI influence the magnitude and recovery trajectory of ABI following an acute bout of exercise across a spectrum of vascular function?
- What association does exercise-induced ABI changes have on patient-reported outcomes of quality of life and intermittent claudication?
- 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study participants | – | –baseline ABI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- recruited from local outpatient rehabilitation, vascular, and internal medicine clinics
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
magnitude of ABI reduction
Time frame: immediately after exercise, at 1-, 3-, and 5-minute recovery intervals.
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.
8 secondary outcomes
Short-Form 36 (SF-36)
Time frame: prior to baseline ABI testing
International Physical Activity Questionnaire (IPAQ)
Time frame: 3 times including at rest prior to 6MWT, at minute 3 and again at minute 6 during 6MWT
Gait speed
Time frame: gait speed between minute 0-1, minute 3-4, and minute 5-6 of 6MWT
Time to first standing rest break
Time frame: 1time during 6MWT
Total duration of all standing rest breaks
Time frame: 1 time during 6MWT
Number of standing rest breaks
Time frame: 1 time during the 6MWT
First standing rest break
Time frame: During the 6MWT
Total walking distance
Time frame: 1 time during the 6MWT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 11454114Gardner 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.
- Background: PubMed 27840332Gerhard-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.
- Background: PubMed 27840333Gerhard-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.
- Background: PubMed 18402904McDermott 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.
- Background: PubMed 25230780Parmenter 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.
- Individual participant dataSharing planned: Undecided. Would need to explore institutional requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease(PAD), run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Murnane, PT, DPT, PhD(c) (318-813-2980, sarah.murnane@lsuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
magnitude of ABI reduction (time frame: immediately after exercise, at 1-, 3-, and 5-minute recovery intervals.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07637396, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.