Exercise Program for Peripheral Arterial Disease
(NICE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAndrew W. Gardner, Ph.D
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Oklahoma
Must not be taking: Cilostazol, Pentoxifylline
Disqualifiers: Active cancer, Kidney failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you started taking cilostazol or pentoxifylline (medications for leg pain) within the last three months.
What data supports the effectiveness of the treatment NICE program, Non-Ischemic Exercise program, for Peripheral Arterial Disease?
Research shows that exercise programs can improve walking ability and blood flow in people with Peripheral Arterial Disease (PAD). Studies have found that both high-intensity and structured home-based exercise programs can lead to better walking distances and improved blood circulation, making exercise a beneficial treatment for PAD.
12345Is the exercise program for peripheral arterial disease safe for humans?
Home-based exercise programs for people with peripheral arterial disease, like the NICE program, have been shown to be generally safe, with a very low rate of adverse events. In a review of 27 studies involving 1642 participants, only four related adverse events were reported over 147,810 patient-hours, indicating a low risk of complications.
26789How is the NICE program treatment for Peripheral Arterial Disease different from other treatments?
The NICE program is unique because it focuses on a non-ischemic exercise approach, which means it emphasizes exercise that does not cause pain, unlike other treatments that may involve high-intensity exercise near maximal pain. This makes it a more sustainable and cost-effective option for improving mobility and quality of life in patients with Peripheral Arterial Disease.
1271011Eligibility Criteria
This trial is for individuals aged 60 or older with Peripheral Artery Disease (PAD) who experience leg pain during walking, confirmed by a treadmill test and an Ankle-Brachial Index (ABI) of <=0.90. Candidates should not have started certain PAD medications recently, had recent revascularization, or have conditions that could affect exercise tolerance other than PAD.Inclusion Criteria
I have leg pain when walking, confirmed by a treadmill test.
My ankle blood pressure drops significantly after exercise.
I have leg pain when walking.
+1 more
Exclusion Criteria
My blood flow in legs is normal, both at rest and after exercise.
I have had or will have surgery to improve blood flow to my limbs.
I started taking medication for leg pain when walking in the last 3 months.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to either the NICE or Standard exercise program and perform supervised treadmill walking for 3 months
12 weeks
Regular supervised sessions
Follow-up
Participants are monitored for changes in exercise and vascular outcomes after the treatment phase
4 weeks
Participant Groups
The study tests the Non-Ischemic Exercise (NICE) program's effectiveness over three months in improving exercise capacity and vascular health in patients with PAD. Participants are randomly assigned to either the NICE program or a control group to compare outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-Ischemic Exercise (NICE) exercise programExperimental Treatment1 Intervention
Patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain.
Group II: Standard exercise programActive Control1 Intervention
Patients will perform supervised treadmill walking for 3 months. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
O'Donoghue Research Building, University of Oklahoma Health Sciences CenterOklahoma City, OK
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Who Is Running the Clinical Trial?
University of OklahomaLead Sponsor
Milton S. Hershey Medical CenterLead Sponsor
Case Western Reserve UniversityCollaborator
National Institute on Aging (NIA)Collaborator
References
Exercise and peripheral vascular disease. [2004]The use of exercise as a nonsurgical therapy for peripheral arterial disease has been shown to be effective. Studies have demonstrated improved walking tolerances, alterations in skeletal muscle metabolism, and improved blood distribution with exercise.
Availability of supervised exercise programs and the role of structured home-based exercise in peripheral arterial disease. [2018]The effectiveness of supervised exercise programs (SEPs) for the management of peripheral arterial disease (PAD) can be hampered by low accessibility and poor compliance. The current international availability and use of SEPs was evaluated and the evidence on alternative approaches such as structured, home-based exercise programs (HEPs) was reviewed. METHODS-MATERIALS: International survey on SEP availability among vascular surgeons using an online questionnaire. A systematic review on structured-HEPs effectiveness was also performed.
The effect of exercise intensity on the response to exercise rehabilitation in patients with intermittent claudication. [2022]The purpose of this randomized trial was to compare the efficacy of a low-intensity exercise rehabilitation program vs a high-intensity program in changing physical function, peripheral circulation, and health-related quality of life in peripheral arterial disease (PAD) patients limited by intermittent claudication.
High-intensity interval training for intermittent claudication in a vascular rehabilitation program. [2019]This article reports an observational study investigating the safety and effectiveness of a high-intensity interval exercise program for patients with peripheral arterial disease. Patients were asked to walk on a treadmill to maximal claudication pain six times in each exercise session, with 3-minute rests in between. Once a patient could walk continuously for 6 minutes without reaching maximal pain, speed and/or grade was increased. To account for the changes in speed and grade, patients' walking ability was measured as a rehabilitation score, calculated as the product of the two. A total of 47 patients were included in the study. Results showed overall improvement in the rehabilitation score with participation in the program, and specifically showed that participation in more exercise sessions led to greater improvement. Moreover, no adverse events occurred in the study patients, suggesting patients with peripheral arterial disease can safely tolerate high-intensity exercise programs.
Structured pain-free exercise progressively improves ankle-brachial index and walking ability in patients with claudication and compressible arteries: an observational study. [2022]In patients with peripheral artery disease (PAD), supervised exercise at near-moderate pain improves walking ability but not ankle-brachial index (ABI) values. In a retrospective observational study, we determined vascular and functional effects of a 6-month structured pain-free exercise program in patients with claudication and compressible vessels. Four-hundred and fifty-nine consecutive patients were studied. Segmental limb pressures were measured and ABI calculated during circa-monthly hospital visits. The 6-min (6MWD) and the pain-free walking distance (PFWD) during the 6-min walking test were determined. Two daily 8-min sessions of slow-moderate in-home walking at increasing metronome-paced speed were prescribed. After excluding patients with unmeasurable ABI or incompletion of the program, 239 patients were studied. Safe and satisfactory (88%) execution of the prescribed training sessions was reported. During the visits, bilateral ABI improved (+ 0.07; p < 0.001) as well as the segmental pressures in the more impaired limb, with changes already significant after 5 weeks of slow walking. Both systolic and diastolic blood pressure decreased overtime (F = 46.52; p < 0.001; F = 5.52; p < 0.001, respectively). 6MWD and PFWD improved (41[0‒73]m p < 0.001 and 107[42‒190]m p < 0.001, respectively) with associated decrease of walking heart rate (F = 15.91; p < 0.001) and Physiological Cost Index (F = 235.93; p < 0.001). The variations of most parameters at different visits correlated to the training load calculated. In a regression model, the PFWD variations directly correlated with rate sessions completed, training load and ABI change and inversely with the baseline value (R2 = 0.27; p < 0.001). In the PAD population studied, moderate pain-free exercise improved ABI with associated progressive functional and cardiovascular changes occurring regardless of subjects characteristics.
Supervised exercise training in patients with lower extremity peripheral artery disease. [2022]The optimal first line management of patients with symptomatic chronic lower extremity peripheral artery disease (PAD) includes secondary prevention of cardiovascular risk factors, pharmacological treatment, and supervised exercise therapy (SET). SET programs have shown to be effective in improving walking performance, functional performance, and quality of life. However, despite a large body of evidence, and despite national and international guidelines recommending SET as first line therapy, SET remains largely underused in patients with chronic PAD. This position paper aims to describe how SET is perceived, its accessibility and structure through Europe. An anonymous web-based survey was used. It comprised 21 questions developed in conjunction with an angiologist and a clinical exercise physiologist specialist in vascular rehabilitation. We had 131 responders from 17 countries. For patients with PAD, SET programs exist only in 59% of European countries. SET reimbursement is available in 41% of countries. SET programs showed to be heterogeneous across countries. Thirty-four percent of the SET programs are PAD-dedicated, while 23% are part of a cardiac rehabilitation program. In addition, among existing SET programs, 65% are dedicated to symptomatic patients with PAD only, 9% to both asymptomatic and symptomatic, 8% to post-revascularized patients only, and 1% to asymptomatic patients with PAD only. Finally, 17% reported not knowing which patients are eligible for enrolment in a SET program. Duration, frequency, and modality of SET also varied from country to country. Overall, these data indicate that a large variability of SET availability and characteristics exists across Europe. Therefore, there is an urgent need to provide detailed guidance to deliver optimal exercise therapeutic care in patients with PAD.
Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial. [2021]Exercise therapy in the intermediate stages of peripheral artery disease (PAD) represents an effective solution to improve mobility and quality of life (QoL). Home-based programs, although less effective than supervised programs, have been found to be successful when conducted at high intensity by walking near maximal pain. In this randomized trial, we aim to compare a low-intensity, pain-free structured home-based exercise (SHB) program to an active control group that will be advised to walk according to guidelines. Sixty PAD patients aged > 60 years with claudication will be randomized with a 1:1 ratio to SHB or Control. Patients in the training group will be prescribed an interval walking program at controlled speed to be performed at home; the speed will be increased weekly. At baseline and after 6 months, the following outcomes will be collected: pain-free walking distance and 6-min walking distance (primary outcome), ankle-brachial index, QoL by the VascuQoL-6 questionnaire, foot temperature by thermal camera, 5-time sit-to-stand test, and long-term clinical outcomes including revascularization rate and mortality. The home-based pain-free exercise program may represent a sustainable and cost effective option for patients and health services. The trial has been approved by the CE-AVEC Ethics Committee (898/20). Registration details: Clinicaltrials.gov NCT04751890 [Registered: 12 February 2021].
Safety of home-based exercise for people with intermittent claudication: A systematic review. [2022]Intermittent claudication (IC) is a classic symptom of peripheral artery disease, with first line treatment being supervised exercise therapy (SET). Despite this, SET is frequently underutilised, and adherence is often poor. An alternative option are home-based exercise programmes (HBEP). Although HBEPs are well tolerated, to the authors' knowledge, no research has assessed their safety. The aim of this review was to assess the safety of HBEPs in people living with IC. We performed an electronic search of the MEDLINE, CINAHL, and Cochrane Library databases. The main parameter of interest was complication rate, calculated as the number of related adverse events per patient-hours. Subanalysis was undertaken to determine differences in safety for studies that did and did not include pre-exercise cardiac screening, and for studies with exercise at low, moderate, and high levels of claudication pain. Our search strategy identified 8693 results, of which 27 studies were included for full review. Studies included 1642 participants completing 147,810 patient-hours of home-based exercise. Four related adverse events were reported, three of which were cardiac in origin, giving an all-cause complication rate of one event per 36,953 patient-hours. Three of these events occurred following exercise to high levels of claudication pain, and one occurred with pain-free exercise. One event occured in a study without cardiac screening. Based on the low number of related adverse events, HBEPs appear to be a safe method of exercise prescription for people with IC. Our results strengthen the rationale for providing alternative exercise options for this population. PROSPERO Registration No.: CRD42021254581.
Lower All-Cause Mortality Risk in Females and Males with Peripheral Artery Disease following Pain-Free Home-Based Exercise: A 7-Year Observational Study. [2023]We evaluated the sex-specific difference in response upon participation in an exercise program with respect to the risk of adverse clinical outcomes among patients with peripheral artery disease (PAD) and claudication. The records of 400 PAD patients were assessed between 2012 and 2015. Two hundred of them were addressed to a walking program prescribed at the hospital and executed at home at symptom-free walking speed (Ex), while the remaining 200 acted as a control group (Co). The number and date of deaths, all-cause hospitalizations, and amputations for a 7-year period were collected from the regional registry. At baseline, no differences were observed (MEXn = 138; FEXn = 62; MCOn = 149; FCOn = 51). The 7-year survival rate was significantly higher in FEX (90%) than in MEX (82% hazard ratio, HR: 0.542 95% CI 0.331-0.885), FCO (45%, HR: 0.164 95% CI 0.088-0.305), and MCO (44%; HR: 0.157 95% CI 0.096-0.256). A significantly lower rate of hospitalization (p < 0.001) and amputations (p = 0.016) was observed for the Ex group compared to the Co group, without differences by sex. In conclusion, in PAD patients, active participation in a home-based pain-free exercise program was associated with a lower rate of death and better long-term clinical outcomes, particularly among women.
Vascular rehabilitation: benefits of a structured exercise/risk modification program. [2017]A vascular rehabilitation program was designed to increase exercise tolerance and reduce the risk of cardiovascular disease in patients with lower extremity arterial occlusive disease. Sixty-eight patients (32 men, 36 women); ages 55 to 85 years (mean, 68 years) with claudication 30 (44%), or recovering from lower extremity revascularization 36 (53%), or endovascular procedures 2 (3%) entered the vascular rehabilitation program. Each underwent a physical examination, risk factor assessment, noninvasive arterial studies, and cardiac evaluation. A history was taken from each patient also. Six patients (9%) were excluded on recognition of silent myocardial ischemia. Sixty-two patients (91%) were accepted for exercise training in a program designed to offer 24 (1-hour) monitored exercise sessions, 12 (1-hour) personalized education lectures, and development of a home maintenance exercise program. No deaths or major morbidity occurred. Seventeen patients (27%) did not finish the program, eight (13%) because of development of significant cardiac, extremity, or cerebrovascular disease and nine for nonmedical reasons. Of the 45 patients (73%) who completed the program, 38 (88%) had documented increases in walking distances of greater than 100% (122% to 450%). All 45 patients designed home exercise programs, and 88% of the smokers quit. Long-term follow-up was available on 100% of the patients. Thirty-eight patients (84%) have been followed for 2 years or more. Thirty-eight (84%) maintained or improved walking distances recorded on exit from the program. Thirty of the 36 patients (83%) who stopped smoking remained nonsmokers. Significant reductions in cholesterol were seen at 1 year, and significant reductions in triglycerides were seen at 12 weeks and 1 year.(ABSTRACT TRUNCATED AT 250 WORDS)
Success of an outpatient claudication group training program for patients with peripheral arterial occlusive disease (PAOD): the Tübingen model. [2006]Active exercise therapy plays a decisive role in the prognosis for early forms of peripheral arterial occlusive disease (stages I and II). We present a model project for an outpatient claudication group which has proved successful in the active exercise therapy of early forms of arterial occlusive disease (PAOD). In addition to the training principles familiar from intensified, performance-keyed walking programs, a newly developed pedal ergometer was employed which makes controlled endurance training possible for this patient group. The distance patients were able to walk without pain increased significantly in 17 out of the 26 patients taking part in the program. This clinical success was confirmed by an examination of arterial hemodynamics. The transformation of a theoretical concept into a functioning training program and the positive results achieved with it should encourage others to establish similar programs close to the patients' homes.