Peripheral Arterial DiseasePREPARE-ITNCT06566976
Prehabilitation and Rehabilitation in PAD
A study testing Exercise Intervention and VAPAHCS Rehabilitation Core Components in people with Peripheral Arterial Disease, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Exercise Intervention and VAPAHCS Rehabilitation Core Components
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 25 Jul 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female adult diagnosed with peripheral artery disease (PAD)
- Experiencing leg pain while walking
- Scheduled to have a stent for PAD
- Able to perform exercise safely
- Postmenopausal and not of child bearing capacity
Who cannot join
- Medically unstable patients
- Recent MI within 3 months
- Malignancy
- Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
- Alcoholism or other recreational drug use
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, 1 recruiting
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Jonathan N Myers, PhD, 650-493-5000 ext. 64661, drj993@aol.com
Charles G Gronau, DCEP, 618-746-6956, gronauc92@gmail.com
About this study
Official title: Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)
To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
Read the detailed description
Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person's ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.
Programs of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.
Although the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Exercise Intervention, VAPAHCS Rehabilitation Core Components
- 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.
Also called Exercise Therapy
Aerobic and resistance exercise will be components of the prehabiliation and rehabilitation programs. Given the presence of PAD, a particular emphasis will be placed on volume of walking and improving walking performance.
VAPAHCS Rehabilitation Core ComponentsOther
The prehabilitation and rehabilitation programs include all Core Components of rehabilitation as outlined in guidelines. The current clinical VAPAHCS program includes smoking cessation, nutrition, risk factor management and psychosocial counseling referrals as appropriate, and these services will be available for the current proposal.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Subjects randomized to the prehabilitation group will undergo 6 weeks of individualized exercise therapy, including a 1-week ramp-up period (3 sessions) conducted at the VAPAHCS rehabilitation facility. Subjects will then exercise primarily at home, with an in-clinic exercise session repeated weekly for the duration of their participation. These sessions will be individualized based on tolerance and in accordance with standardized guidelines, but will generally consist of 45-60 min of supervised exercise that combines aerobic and resistance training, including warm-up and cool-down. Throughout the study, subjects will be asked to perform 30 minutes of daily unsupervised aerobic exercise of their choice, with an emphasis on improving walking performance at home. Guidelines for patient monitoring, safety, and prescription outlined by the American Heart Association, American College Sports Medicine, and American Association of Cardiovascular and Pulmonary Rehabilitation will be followed. Receives: Other: Exercise Intervention; Other: VAPAHCS Rehabilitation Core Components |
| Rehabilitation | Active comparator | Subjects randomized to the rehabilitation group will initiate exercise sessions approximately 2-weeks following endovascular intervention as outlined in guidelines for PAD. Patient stability and wound patency will be paramount considerations prior to a patient beginning the rehabilitation program. Similar to prehabilitation, subjects will undergo a 1-week, 3 session familiarization period conducted at the VAPAHCS rehabilitation facility, then return once weekly for in-clinic supervised sessions. The weekly in-person visits will be conducted at the rehabilitation center to monitor and encourage compliance, review activity questionnaires, download accelerometry data, and address any clinical concerns. Similar to participants in the prehabilitation group, the 6-week rehabilitation period will be individualized and follow standardized guidelines designed for rehabilitation in patients with PAD. Receives: Other: Exercise Intervention; Other: VAPAHCS Rehabilitation Core Components |
| Prehabiliation and Rehabilitation | Experimental | Subjects randomized to the prehabilitation and rehabilitation group will undergo both the 6 weeks of prehabilitation pre-operative and 6 weeks of rehabilitation post-operative as described in their respective arm descriptions. Receives: Other: Exercise Intervention; Other: VAPAHCS Rehabilitation Core Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to claudication pain
Time to initial onset of claudication pain with exercise treadmill test.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Secondary outcomes (30)
Peak VO2
Peak V02 will be determined on a treadmill using an individualized ramp protocol with collection of continuous ventilatory gas exchange responses.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
6-minute walk test (6MWT)
Total distance (meters) of walk in 6 minutes.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Walking Impairment Questionnaire (WIQ)
Developed to evaluate walking limitations in patients with PAD. Assesses the ability of individuals to walk defined distances and speeds and climb stairs.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Peripheral Artery Questionnaire (PAQ)
20-item questionnaire developed and validated specifically for PAD and is designed to quantify patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Walking
Physical activity patterns, expressed as steps/day will be quantified using fitness/health tracking device.
Measured: Up to 22 weeks
Energy expenditure
Energy expenditure will be quantified using fitness/health tracking device.
Measured: Up to 22 weeks
Chair raises
Number of repetitions completed within 60 seconds (46cm high seat).
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Upper body strength
1 repetition max for Chest Press.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Lower body strength
1 repetition max for Leg Extension.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Hand grip strength
Maximum isometric strength will be measured using a hand grip dynamometer.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Insulin sensitivity
Fasting glucose and insulin samples will be obtained from blood draw to generate Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Lipid panel
Fasting total cholesterol, LDL, HDL and triglycerides will be assessed from blood draw.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Sodium
Standard Chem 20 blood draw will be used to obtain sodium in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Homocysteine
Homocysteine will be assessed from blood draw.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
High-sensitivity C-reactive protein (hs-CRP)
High-sensitivity C-reactive protein (hs-CRP) will be assessed from blood draw.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Interleukin-6 (IL-6)
Interleukin-6 (IL-6) will be assessed from blood draw.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
D-dimer
D-dimer will be assessed from blood draw.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood protein
Blood draw will be used to obtain blood protein value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Albumin
Blood draw will be used to obtain albumin in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Calcium
Blood draw will be used to obtain calcium in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Potassium
Blood draw will be used to obtain potassium in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Chloride
Blood draw will be used to obtain chloride in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Carbon dioxide
Blood draw will be used to obtain carbon dioxide in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
AST/GOTU/l
Blood draw will be used to obtain AST/GOTU/l in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
ALT/GPT
Blood draw will be used to obtain ALT/GPT in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
ALK Phosphatase
Blood draw will be used to obtain ALT/GPT in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Bilirubin
Blood draw will be used to obtain total bilirubin in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Urea Nitrogen
Blood draw will be used to obtain urea nitrogen in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Creatinine
Blood draw will be used to obtain creatinine in blood value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
eGFR
Blood draw will be used to obtain eGFR value.
Measured: Baseline, 6 weeks, 14 weeks, 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start7 Mar 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion25 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (143)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jonathan Myers, Palo Alto Veterans Institute for Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566976
- Sponsor's protocol ID
- MYE0018APR
- Acronym
- PREPARE-IT
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Correction. Circ Res. 2015 Jun 19;117(1):e12. doi: 10.1161/RES.0000000000000059. No abstract available.
PubMed 26089368Mayfield JA, Reiber GE, Maynard C, Czerniecki J, Sangeorzan B. The epidemiology of lower-extremity disease in veterans with diabetes. Diabetes Care. 2004 May;27 Suppl 2:B39-44. doi: 10.2337/diacare.27.suppl_2.b39.
PubMed 15113781Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018 Aug;275:379-381. doi: 10.1016/j.atherosclerosis.2018.05.033. Epub 2018 May 22. No abstract available.
PubMed 29843915Horvath L, Nemeth N, Feher G, Kives Z, Endrei D, Boncz I. Epidemiology of Peripheral Artery Disease: Narrative Review. Life (Basel). 2022 Jul 12;12(7):1041. doi: 10.3390/life12071041.
PubMed 35888129Garg PK, Liu K, Tian L, Guralnik JM, Ferrucci L, Criqui MH, Tan J, McDermott MM. Physical activity during daily life and functional decline in peripheral arterial disease. Circulation. 2009 Jan 20;119(2):251-60. doi: 10.1161/CIRCULATIONAHA.108.791491. Epub 2008 Dec 31.
PubMed 19118256McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001 Oct 3;286(13):1599-606. doi: 10.1001/jama.286.13.1599.
PubMed 11585483McDermott MM, Liu K, Ferrucci L, Tian L, Guralnik JM, Liao Y, Criqui MH. Greater sedentary hours and slower walking speed outside the home predict faster declines in functioning and adverse calf muscle changes in peripheral arterial disease. J Am Coll Cardiol. 2011 Jun 7;57(23):2356-64. doi: 10.1016/j.jacc.2010.12.038.
PubMed 21636037Hamburg NM, Balady GJ. Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits. Circulation. 2011 Jan 4;123(1):87-97. doi: 10.1161/CIRCULATIONAHA.109.881888. No abstract available.
PubMed 21200015Myers JN, Fonda H. The Impact of Fitness on Surgical Outcomes: The Case for Prehabilitation. Curr Sports Med Rep. 2016 Jul-Aug;15(4):282-9. doi: 10.1249/JSR.0000000000000274.
PubMed 27399826Myers J, Niebauer J, Humphrey R. Prehabilitation Coming of Age: IMPLICATIONS FOR CARDIAC AND PULMONARY REHABILITATION. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):141-146. doi: 10.1097/HCR.0000000000000574.
PubMed 33512981Cheng XS, Myers JN, Chertow GM, Rabkin R, Chan KN, Chen Y, Tan JC. Prehabilitation for kidney transplant candidates: Is it time? Clin Transplant. 2017 Aug;31(8). doi: 10.1111/ctr.13020. Epub 2017 Jul 10.
PubMed 28564126Brunelli A, Kim AW, Berger KI, Addrizzo-Harris DJ. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e166S-e190S. doi: 10.1378/chest.12-2395.
PubMed 23649437Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):e278-333. doi: 10.1161/CIR.0000000000000106. Epub 2014 Aug 1. No abstract available.
PubMed 25085961Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
PubMed 29268916Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
PubMed 30304509
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation and Rehabilitation in PAD: A Randomized Exercise Intervention Trial (PREPARE-IT)
- ClinicalTrials.gov ID
- NCT06566976
- Acronym / sponsor ID
- PREPARE-IT / MYE0018APR
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 22 Aug 2024 (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.
To determine the effectiveness of pre and post-operative exercise therapy in patients undergoing peripheral artery stenting for peripheral arterial disease.
Detailed description
Peripheral artery disease (PAD) is a form of cardiovascular disease that affects the arteries supplying blood flow to the legs. The prevalence of PAD is increasing rapidly in the United States. When PAD is severe, it can cause pain with movement and limit a person's ability to walk or perform their normal daily activities. With severe PAD, a procedure is often performed in which an artery is held open with a small tube called a stent.
Programs of exercise-based rehabilitation have been shown to greatly help these patients in terms of the pain they experience with walking, their ability to perform daily activities or those required by work, and improved quality of life. There is also a newer form of therapy, called prehabilitation, which has been shown to have important benefits for patients with PAD. Prehabilitation involves four to six weeks of exercise therapy and lifestyle recommendations before undergoing a stent procedure. Prehabilitation helps patients improve exercise tolerance and make lifestyle changes that improve risk factors before the procedure. Those who participate in prehabilitation programs have fewer complications with the stent procedure, spend fewer days in the hospital, and have a better ability to exercise and return to work more quickly.
Although the benefits of prehabilitation and rehabilitation are well established, most doctors neglect to recommend these treatments to their patients who undergo a stent procedure for PAD. The research team will study the impact of prehabilitation, rehabilitation or both forms of therapy. The results will likely encourage more doctors to recommend the best option for their patients, and possibly to recommend both prehabilitation and rehabilitation among patients who are having a stent procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: Exercise Intervention, Other: VAPAHCS Rehabilitation Core ComponentsSubjects randomized to the prehabilitation group will undergo 6 weeks of individualized exercise therapy, including a 1-week ramp-up period (3 sessions) conducted at the VAPAHCS rehabilitation facility. Subjects will then exercise primarily at home, with an in-clinic exercise session repeated weekly for the duration of their participation. These sessions will be individualized based on tolerance and in accordance with standardized guidelines, but will generally consist of 45-60 min of supervised exercise that combines aerobic and resistance training, including warm-up and cool-down. Throughout the study, subjects will be asked to perform 30 minutes of daily unsupervised aerobic exercise of their choice, with an emphasis on improving walking performance at home. Guidelines for patient monitoring, safety, and prescription outlined by the American Heart Association, American College Sports Medicine, and American Association of Cardiovascular and Pulmonary Rehabilitation will be followed. |
| Rehabilitation | Active comparator | Other: Exercise Intervention, Other: VAPAHCS Rehabilitation Core ComponentsSubjects randomized to the rehabilitation group will initiate exercise sessions approximately 2-weeks following endovascular intervention as outlined in guidelines for PAD. Patient stability and wound patency will be paramount considerations prior to a patient beginning the rehabilitation program. Similar to prehabilitation, subjects will undergo a 1-week, 3 session familiarization period conducted at the VAPAHCS rehabilitation facility, then return once weekly for in-clinic supervised sessions. The weekly in-person visits will be conducted at the rehabilitation center to monitor and encourage compliance, review activity questionnaires, download accelerometry data, and address any clinical concerns. Similar to participants in the prehabilitation group, the 6-week rehabilitation period will be individualized and follow standardized guidelines designed for rehabilitation in patients with PAD. |
| Prehabiliation and Rehabilitation | Experimental | Other: Exercise Intervention, Other: VAPAHCS Rehabilitation Core ComponentsSubjects randomized to the prehabilitation and rehabilitation group will undergo both the 6 weeks of prehabilitation pre-operative and 6 weeks of rehabilitation post-operative as described in their respective arm descriptions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female adult diagnosed with peripheral artery disease (PAD)
- Experiencing leg pain while walking
- Scheduled to have a stent for PAD
- Able to perform exercise safely
- Postmenopausal and not of child bearing capacity
Key exclusion criteria (5 listed)
- Medically unstable patients
- Recent MI within 3 months
- Malignancy
- Uncontrolled diabetes mellitus (HBA1C ≥8 mmol/l)
- Alcoholism or other recreational drug use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionAlso: Exercise TherapyAerobic and resistance exercise will be components of the prehabiliation and rehabilitation programs. Given the presence of PAD, a particular emphasis will be placed on volume of walking and improving walking performance. | Other | Prehabiliation and Rehabilitation, Prehabilitation, Rehabilitation |
| VAPAHCS Rehabilitation Core ComponentsThe prehabilitation and rehabilitation programs include all Core Components of rehabilitation as outlined in guidelines. The current clinical VAPAHCS program includes smoking cessation, nutrition, risk factor management and psychosocial counseling referrals as appropriate, and these services will be available for the current proposal. | Other | Prehabiliation and Rehabilitation, Prehabilitation, Rehabilitation |
Primary outcome
Time to claudication pain
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Time to initial onset of claudication pain with exercise treadmill test.
30 secondary outcomes
Peak VO2
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
6-minute walk test (6MWT)
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Walking Impairment Questionnaire (WIQ)
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Peripheral Artery Questionnaire (PAQ)
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Walking
Time frame: Up to 22 weeks
Energy expenditure
Time frame: Up to 22 weeks
Chair raises
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Upper body strength
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Lower body strength
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Hand grip strength
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Insulin sensitivity
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Lipid panel
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Sodium
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Homocysteine
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
High-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Interleukin-6 (IL-6)
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
D-dimer
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Blood protein
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Albumin
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Calcium
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Potassium
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Chloride
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Carbon dioxide
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
AST/GOTU/l
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
ALT/GPT
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
ALK Phosphatase
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Bilirubin
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Urea Nitrogen
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
Creatinine
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
eGFR
Time frame: Baseline, 6 weeks, 14 weeks, 22 weeks
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 22 Aug 2024.
- Background: PubMed 26089368Correction. Circ Res. 2015 Jun 19;117(1):e12. doi: 10.1161/RES.0000000000000059. No abstract available.
- Background: PubMed 15113781Mayfield JA, Reiber GE, Maynard C, Czerniecki J, Sangeorzan B. The epidemiology of lower-extremity disease in veterans with diabetes. Diabetes Care. 2004 May;27 Suppl 2:B39-44. doi: 10.2337/diacare.27.suppl_2.b39.
- Background: PubMed 29843915Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018 Aug;275:379-381. doi: 10.1016/j.atherosclerosis.2018.05.033. Epub 2018 May 22. No abstract available.
- Background: PubMed 35888129Horvath L, Nemeth N, Feher G, Kives Z, Endrei D, Boncz I. Epidemiology of Peripheral Artery Disease: Narrative Review. Life (Basel). 2022 Jul 12;12(7):1041. doi: 10.3390/life12071041.
- Background: PubMed 19118256Garg PK, Liu K, Tian L, Guralnik JM, Ferrucci L, Criqui MH, Tan J, McDermott MM. Physical activity during daily life and functional decline in peripheral arterial disease. Circulation. 2009 Jan 20;119(2):251-60. doi: 10.1161/CIRCULATIONAHA.108.791491. Epub 2008 Dec 31.
- Background: PubMed 11585483McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001 Oct 3;286(13):1599-606. doi: 10.1001/jama.286.13.1599.
- Background: PubMed 21636037McDermott MM, Liu K, Ferrucci L, Tian L, Guralnik JM, Liao Y, Criqui MH. Greater sedentary hours and slower walking speed outside the home predict faster declines in functioning and adverse calf muscle changes in peripheral arterial disease. J Am Coll Cardiol. 2011 Jun 7;57(23):2356-64. doi: 10.1016/j.jacc.2010.12.038.
- Background: PubMed 21200015Hamburg NM, Balady GJ. Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits. Circulation. 2011 Jan 4;123(1):87-97. doi: 10.1161/CIRCULATIONAHA.109.881888. No abstract available.
- Background: PubMed 27399826Myers JN, Fonda H. The Impact of Fitness on Surgical Outcomes: The Case for Prehabilitation. Curr Sports Med Rep. 2016 Jul-Aug;15(4):282-9. doi: 10.1249/JSR.0000000000000274.
- Background: PubMed 33512981Myers J, Niebauer J, Humphrey R. Prehabilitation Coming of Age: IMPLICATIONS FOR CARDIAC AND PULMONARY REHABILITATION. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):141-146. doi: 10.1097/HCR.0000000000000574.
- Background: PubMed 28564126Cheng XS, Myers JN, Chertow GM, Rabkin R, Chan KN, Chen Y, Tan JC. Prehabilitation for kidney transplant candidates: Is it time? Clin Transplant. 2017 Aug;31(8). doi: 10.1111/ctr.13020. Epub 2017 Jul 10.
- Background: PubMed 23649437Brunelli A, Kim AW, Berger KI, Addrizzo-Harris DJ. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e166S-e190S. doi: 10.1378/chest.12-2395.
- U.S. Markets for Peripheral Vascular StentsLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Bloom E. Prehabilitation evidence and insight review. Macmillan National Cancer Rehabilitation, 2018.Link provided by the sponsor.
- Carrol AE, Frakt, A. It Saves Lives. It can save money. So why aren't we spending more on public health? NY Times 5/28/18Link provided by the sponsor.
- Centers for Medicare \& Medicaid Services. Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery DiseaseLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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?
A study testing Exercise Intervention and VAPAHCS Rehabilitation Core Components in people with Peripheral Arterial Disease, run by Palo Alto Veterans Institute for Research 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Aug 2024. 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 Jonathan N Myers, PhD (650-493-5000 ext. 64661, drj993@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to claudication pain (time frame: Baseline, 6 weeks, 14 weeks, 22 weeks). 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 NCT06566976, which also lists 143 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 22 Aug 2024.