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PubMed1996

The Intermittent Claudication Research Study: vascular outcomes research using home health nurses.

This article describes an ongoing, multicenter outcomes research study on intermittent claudication being conducted at 16 Chicago-area vascular surgery offices and clinics. The study relies on gathering data through a series of home health follow-up visits by visiting nurses who use portable Doppler equipment. A total of 624 patients (506 men and 118 women) have been enrolled to date. Data on study patients' baseline demographic characteristics, leg symptoms, peripheral blood flow, comorbidities, and walking impairments are presented. Initial physical functioning and walking-distance scores from patient self-report questionnaires are also presented, along with attrition and lower-extremity revascularization rates. The contribution of nursing to this type of patient outcomes research is discussed. The changing climate in health care delivery provides nursing with a great opportunity to influence the U.S. health care system. In particular, the participation of nurses can make a major contribution to research on patient outcomes and medical effectiveness, and especially to new methods of comparing treatment effects on patients' functional status. Interpretation and measurement of patient self-reported health status and quality of life are particularly relevant to nursing, which is based on interventions related to compromised function. Improvement of patients' physical functioning is the heart of nursing practice, and the focus of much of what is done in vascular medicine and surgery. This article describes the contribution of nursing skills and knowledge to an ongoing, government-funded, multicenter research study on intermittent claudication. The ability of nurses to make a unique contribution to outcomes research is demonstrated.

Activities of Daily Living↗
PubMed2005

[The history of intermittent claudication due to arterial disease].

The clinical description of intermittent claudication due to arterial occlusive disease was made by two French precursors: a veterinary surgeon, Jean-François Bouley, and a neurologist, Jean-Martin Charcot. The subsequent works clarified the aetiology, the investigations and the treatment of this trouble but did not add anything to the initial description.

Arterial Occlusive Diseases↗
PubMed2004

Activation of extracellular signal-regulated protein kinase in dorsal horn neurons in the rat neuropathic intermittent claudication model.

Extracellular signal-regulated protein kinase (ERK) is a mitogen-activated protein kinase (MAPK) that mediates several cellular responses to mitogenic and differentiation signals, and activation of ERK in dorsal horn neurons by noxious stimulation is known to contribute to pain hypersensitivity. In order to elucidate the pathophysiological mechanisms of the cauda equina syndrome, secondary to spinal canal stenosis, we evaluated walking dysfunction triggered by forced exercise and activation of ERK in the dorsal horn using a rat model of neuropathic intermittent claudication. Rats in the lumbar canal stenosis (LCS) group showed a shorter running distance from 1 to 14 days after surgery. Two minutes after running on the treadmill apparatus, phosphorylation of ERK was induced in neurons in the superficial laminae in the LCS group but not in the sham group, whereas there was no change in the deeper laminae. Intrathecal administration of the MAPK kinase inhibitor, U0126, 30 min before running, clearly increased the running distance, whereas there was no significant change in the vehicle control group 3 days after surgery. In addition, a prostaglandin E1 analog, OP-1206 alpha-CD, administered orally, improved the walking dysfunction, and further, inhibited activation of ERK following running 7 days after surgery. These findings suggest that intermittent claudication triggered by forced walking might affect the phosphorylation of ERK in the superficial laminae, possibly via transient (partial) ischemia of the spinal cord. ERK activation in the dorsal horn neurons may be involved in the transient pain in the neuropathic intermittent claudication model.

Alprostadil↗
PubMed1978

[The effect of oxyfedrine and intervall training in intermittent claudication (author's transl)].

In 23 patients suffering from intermittent claudication due to chronic occlusions of the femoral artery proved on angiography, a double-blind study was performed to compare the effects of treatment with oxyfedrine and interval-training and of interval-training alone. The claudication distance, physical work capacity and physical work intensity were measured on the treadmill before, during and after 10-weeks training period in each case. After training, the walking ability improved in both groups, however, quantitatively being more pronounced in the oxyfedrine group. In the placebo group, the increase in physical work intensity was mainly caused by the improvement of walking ability in patients with higher levels of performance at the beginning of the training. In the oxyfedrine group, on the other hand, a continuous and regular increase in physical work intensity was found at all levels of performance and during the whole training period. For the differences found, blood supply lowering mechanisms after physical training and improvement of collaterals after combination oxyfedrine and physical training are discussed. The possibility of additive action of the pharmacologic treatment and physical training are pointed out.

Aged↗
PubMed1996

Metal excretion and magnesium retention in patients with intermittent claudication treated with intravenous disodium EDTA.

Sixty patients with intermittent claudication participated in a double-blind placebo-controlled trial of 20 courses of intravenous chelation therapy with 3 g of disodium EDTA vs placebo during 5-9 weeks. After the first infusion, the 24-h urinary excretion of lead and zinc was approximately 25-fold higher in the EDTA-treated group; relative differences for copper and calcium were smaller. Urinary magnesium excretion in the EDTA-treated group was one-third less than in the control group. After the treatment period, the blood lead concentration had decreased by approximately 73% and the serum zinc concentration by approximately 34%; other changes in blood concentrations were negligible. The loss of essential minerals and the possible redistribution of lead in the body may constitute a disadvantage that should be taken into account in repeated intravenous EDTA treatment.

Adult↗
PubMed2005

Intermittent claudication: exercise-increased walking distance is not related to improved cardiopulmonary fitness.

OBJECTIVES: To assess if exercise training improves the symptoms of intermittent claudication by improvement in cardiopulmonary fitness. METHODS: Claudication distance (CD), maximum walking distance (MWD), calf endurance (repetitive heel raises), cardiovascular fitness (VO2 peak), and ankle-brachial pressure index (ABPI) were measured in 16 subjects with intermittent claudication before, and following an 8-week treadmill training programme. RESULTS: Training resulted in a median increase in CD of 65.5 m (p<0.01), MWD of 339.5 m (p<0.001) and HR of 19 (p<0.03). Notably, improvements in MWD correlated with those in HR (p=0.001; R=0.75). There was no training-associated change in VO2 peak (median increase of only 0.35 ml/kg/min; p=0.60) or ABPI (median increase of only 0.01; p=0.64). CONCLUSION: In this study, overall improvement in claudication was not related to an improvement in cardiopulmonary fitness.

Aged↗
PubMed2001

Intermittent claudication: effective medical management of a common circulatory problem.

Intermittent claudication (IC), most often characterized by a reproducible, painful aching or cramping in muscle groups of the leg caused by walking and relieved by rest, is a common, lifestyle-limiting symptom of lower-extremity peripheral arterial occlusive disease. Because IC is usually indicative of systemic atherosclerosis, active investigation and treatment are recommended. Positive outcomes have been shown with a treatment regimen including risk-factor modification, particularly smoking cessation and control of diabetes, exercise, and pharmacotherapy. Pentoxifylline has been used since 1984 for the treatment of IC with indifferent results. Recently, clinical trials with cilostazol, a drug approved for use in the United States, have shown significant effectiveness in IC patients, generally doubling their maximal walking distance at 24 weeks of treatment. Cilostazol has also been shown to be significantly more effective than pentoxifylline in improving pain-free and maximal walking distance. Other classes of drugs, such as platelet antiaggregants, are being studied for the treatment of IC, but little efficacy has been shown. Arterial revascularization by endovascular or surgical methods is an additional option but must be considered on an individual basis depending on severity of symptoms and disability in each patient.

Angioplasty↗
PubMed2005

The US experience with cilostazol in treating intermittent claudication.

The management of peripheral arterial disease (PAD) patients with intermittent claudication (IC) requires both aggressive risk management and targeted symptomatic therapies. The phosphodiesterase inhibitor cilostazol is the only US Food and Drug Administration (FDA) approved medication to demonstrate consistent benefits on both objective measures of exercise capacity and subjective measures of everyday functioning and quality of life. Pentoxifylline is also approved by the FDA for the treatment of claudication, but with less clinical benefit than cilostazol. This report will provide an overview of cilostazol's role in the treatment of patients with IC. Data will be presented regarding the safety and efficacy demonstrated by cilostazol in clinical trials, as well as the effects of risk-factor control, exercise therapy, revascularization, and experimental drugs on the treatment of claudication in the PAD population. Based on the available evidence, a comprehensive approach to claudication management is recommended.

Cilostazol↗
PubMed2004

Studies on the effectiveness and safety of cilostazol, beraprost sodium, prostaglandin E1 for the treatment of intermittent claudication.

To study the effectiveness for the treatment of intermittent claudication (IC) of three drugs with antiplatelet effects, cilostazol, beraprost sodium, and prostaglandin E(1) (PGE(1)), by using a systemic review of literature and a meta-analysis. A search was undertaken for studies reported between 1966-2002 in the MEDLINE database, and references in published articles and reviews were obtained. Data for maximum walking distance (MWD), pain-free walking distance (PFWD), and adverse clinical events were extracted from the articles that met the inclusion criteria. The pooled estimates of the weighted mean differences (WMD) of MWD and PFWD for cilostazol were 52.19 m [95% confidence interval (CI) 32.08, 72.31] and 39.75 m [95% CI 23.39, 56.10], and those for PGE(1) were 100.27 m [95% CI 15.76, 184.78] and 55.73 [95% CI 21.54, 89.92], respectively. These differences were statistically significant between the test drugs and placebo. However there was no statistical significance difference between beraprost sodium and placebo, even though there was one study that showed a tendency for improvement in walking distance. The total rate of adverse clinical events in cilostazol and beraprost sodium was higher than that for placebo, while there was no statistical significant difference between PGE(1) and placebo, although PGE(1) had a higher tendency for adverse clinical events. The literature evaluation results and the meta-analysis suggest that these two drugs (cilostazol and PGE(1)) can be considered to be effective drugs for the treatment of IC. Due to current availability of only a few clinical reports, further studies are needed to clarify the efficacy of beraprost sodium in the treatment of IC.

Alprostadil↗
PubMed1991

Effects of vacusac in intermittent claudication: a controlled cross-over study.

The effect of a new physical treatment modality, Vacusac, was tested on a group of patients with stable intermittent claudication. Twenty-two patients with a median age of 65 years and a median duration of intermittent claudication of 5 years were randomized to either active or placebo treatments. Seventeen patients completed the study. The effect of treatment was quantified by measurements of systemic and peripheral systolic blood pressures and by measurements of the pain-free and the maximal walking distance on a treadmill. The ankle pressure index (ankle systolic pressure/arm systolic pressure) and toe pressure index (toe systolic pressure/arm systolic pressure) were calculated. After 25 active treatments, administered over a period of 2 months, the patients allocated to this group attained a significant increase in the pain-free walking distance from 54 m (24-107 m) to 99 m (30-420 m) (P less than 0.05) and in the maximal walking distance from 99 m (36-182 m) to 185 m (68-591 m) (P less than 0.05). The patient group receiving 25 placebo treatments did not show any significant changes in either the pain-free or the maximal walking distance. This group then received 25 active treatments over a period of 2 months. This active treatment resulted in a significant increase in the pain-free walking distance from 51 m (14-100 m) to 86 m (18-1000 m) (P less than 0.05) and in the maximal walking distance from 98 m (40-199 m) to 175 m (51-1000 m) (P less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed2000

Effect of cloricromene on intermittent claudication. A randomized, double-blind, placebo-controlled trial in patients treated with aspirin: effect on claudication distance and quality of life. CRAMPS Investigator Group. Cloricromene Randomized Arteriopathy Multicenter Prospective Study.

The main aim of medical treatment for intermittent claudication (IC) is the reduction of mortality and morbidity from ischemic cardiovascular disease. However, symptomatic treatment with the aim of improving exercise performance and the overall quality of life may also be an important target of the clinical management of patients with intermittent claudication. Cloricromene, a drug with antithrombotic and anti-ischemic activities, has previously shown some promising results in patients with claudication. We have carried out a clinical trial to assess the effect of cloricromene on the claudication distance and on the quality of life of patients with IC chronically treated with aspirin. A total of 159 patients with IC, Stage II (Fontaine), were enrolled in a double-blind, randomized, prospective, multicenter study comparing cloricromene (100 mg orally b.i.d.) or an identical placebo for 6 months. All patients received 160 mg/day aspirin. The primary end-point was the improvement of initial claudication distance (ICD) at 6 months as measured by a standardized treadmill test. The secondary end-points were the absolute claudication distance (ACD) at 6 months, the percentage of patients defined as responders to treatment (improvement of ICD of at least 40%), changes in the ischemic window (IW), quality of life as assessed by the SF-36 questionnaire, and the occurrence of major cardiovascular events. The ICD increased in both treatment groups, with a non-significant difference at 6 months in favor of cloricromene of +12.3 m. The ACD, percentage of responders to treatment and ischemic window also improved in both groups with a slight, non-significant trend in favor of cloricromene. Pretreatment quality of life scores showed only a slight worsening compared with an age-matched, healthy population and did not change upon treatment. A post hoc subgroup analysis showed a significant benefit from cloricromene in patients with an ICD at enrollment higher than the median of the patient population. In conclusion, treatment with cloricromene for 6 months does not significantly improve claudication in patients with Stage II Fontaine peripheral arteriopathy chronically treated with aspirin. An improvement of 40-60 m in the ICD on a standardized treadmill test does not translate into a self-perceived improvement in the quality of life as assessed by the SF-36 questionnaire.

Adult↗
PubMed2003

Endovascular stents for intermittent claudication.

BACKGROUND: Endovascular stents have been suggested as a means to improve the patency of arteries after angioplasty in patients with intermittent claudication. OBJECTIVES: The null hypothesis to be tested by this review is that for individuals with claudication, the use of an endovascular stent in addition to percutaneous transluminal angioplasty, does not improve symptoms of life-style limiting claudication, when compared to percutaneous angioplasty alone. SEARCH STRATEGY: We searched the Specialised Register of the Cochrane Peripheral Vascular Disease Group, (last searched October 2002), and the Cochrane Central Register of Controlled Trials (CENTRAL), (last searched Issue 3, 2002). We also searched MEDLINE and EMBASE (up to and including January 2001); bibliographies of published data, and hand searched the Journal of Vascular Interventional Radiology (1990-2001). Enquiries were made to stent manufacturers for unpublished trial data. SELECTION CRITERIA: Randomised trials comparing angioplasty alone, versus angioplasty with endovascular stents, in subjects with intermittent claudication. DATA COLLECTION AND ANALYSIS: Both reviewers independently assessed trial quality and extracted the data. Only published trial data were used. Effectiveness was measured by pre-defined primary outcome measures: restenosis / reocclusion rates and maximum walking distance. MAIN RESULTS: Two trials were included with a total sample size of 104 subjects. Both trials included only individuals with femoro-popliteal disease and compared angioplasty and stenting with the Palmaz stent against angioplasty alone. Although one study showed a slight statistical advantage in arterial patency after angioplasty alone, this was not found when the two studies were combined. No differences in the secondary outcomes in either study were detected. REVIEWER'S CONCLUSIONS: The small number of relevant trials identified, together with the small sample sizes and methodological weaknesses, severely limit the usefulness of this review in guiding practice. Larger multicentre trials are needed.

Adult↗
PubMed1996

Surgical treatment of a sacral nerve root cyst with intermittent claudication in an 85-year-old patient: case report.

The following presents a case of an 85-year-old woman with intermittent claudication of a sacral nerve root cyst. The cyst wall was incised and oversewn while preserving the surrounding nerve fibers by microscopic procedures. All symptoms were eliminated following the operation. The syndrome of intermittent claudication may possibly arise while walking from the transient influx of cerebrospinal fluid into a cyst in a relatively narrow sacral canal. The present case may indicate that a sacral nerve root cyst is curable even in aged patients through thorough evaluation and management.

Age Factors↗
PubMed1987

Effect of training on the post-exercise ankle blood pressure reaction in patients with intermittent claudication.

The effect of physical training on the post-exercise blood pressure reaction in the ankle was studied in 63 patients with intermittent claudication but without angina pectoris. After three months of supervised training the maximal walking distance increased by 67% and the pain-free walking distance by 73%. Compared with that after the pre-training treadmill test, the ankle blood pressure was significantly higher 2-16 min after the post-training test and more rapidly returned to the initial resting value, both with similar work loads and with a higher post-training work load. Blood pressure measurement in the ankle after exercise is useful as an objective test of the circulatory effect of training in patients with intermittent claudication.

Aged↗
PubMed1985

Factors of prognostic importance for subsequent rest pain in patients with intermittent claudication.

The risk of developing rest pain during a six-year period was studied in 224 non-diabetic patients with intermittent claudication. Both smoking and multiple arterial stenoses in the leg were significantly correlated with an increased risk of developing rest pain. In non-smokers and in those who had stopped smoking within one year after the initial examination, the cumulative percentage of patients without rest pain after six years was 92, and in smokers and those who stopped smoking after more than one year it was 79 (p less than 0.03 after adjustment for differences in the presence of multiple stenoses). In patients with single stenosis the cumulative percentage of patients without rest pain was 86, and in those with multiple stenoses 70 (p less than 0.05 after adjustment for differences in smoking habits). The results emphasize how important it is that patients with intermittent claudication do not smoke. The increased risk of rest pain associated with the presence of multiple arterial stenoses in the leg should be considered when making decisions concerning vascular surgery.

Aged↗
PubMed1986

Fate in intermittent claudication: outcome and risk factors.

The fate of 257 consecutive patients (100 women) aged 36-85 years (mean 65) first seen with intermittent claudication in 1977 was analysed after a mean of 6.5 (SD 0.5) years. When first seen none of the patients complained of rest pain or had ulcers or gangrenous lesions on the feet. At follow up 113 of the patients (44%) had died. Causes of death were no different from those in the general population. Mortality was twice that of the general population matched for age and sex. Mortality among the men was twice that among the women. In men under 60 mortality was four times that expected. The rate of clinical progression of the arteriosclerotic disease (that is, rest pain or gangrene) of the worst affected leg was 7.5% in the first year after referral. Thereafter the rate was 2.2% a year. An ankle systolic blood pressure below 70 mm Hg, a toe systolic blood pressure below 40 mm Hg, or an ankle/arm pressure index below 50% were individually significantly associated with progression of the arteriosclerotic disease. These findings show the importance of peripheral blood pressure measurements in the management of patients with intermittent claudication due to arteriosclerotic disease.

Adult↗
PubMed1996

A dose-effect study of beraprost sodium in intermittent claudication.

We compared the efficacy and safety of three doses of beraprost sodium, an epoprostenol analogue, with placebo in the treatment of intermittent claudication (Fontaine's stage II). One hundred sixty-four patients were randomized to receive either placebo, 20 micrograms beraprost sodium (BPS60 group), 40 micrograms beraprost sodium (BPS120 group), or 60 micrograms beraprost sodium (BPS180 group) three times daily administered orally in a double-blind manner for 12 weeks. Treadmill exercise tests were performed twice during an initial selection phase (D-28 and D0) at week 10 (at trough beraprost concentration) and week 12 (at peak beraprost concentration) of the treatment phase. At week 10, all groups showed an increase in pain-free walking distance, and this distance was greatest in the BPS60 and BPS120 groups (p = 0.055). At week 12, a similar pattern was observed, and the difference was significant between the groups (p = 0.023). The most frequent adverse events reported were gastrointestinal disorders, headaches, skin disorders, and flushes. Patients who received either 60 or 120 micrograms of beraprost sodium daily had an increased pain-free walking distance. Further studies are required to investigate why the highest dose used (180 micrograms daily) showed lower efficacy. Having both vasodilating and antiplatelet properties and being able to increase pain-free walking distance in the short term, beraprost sodium is a promising drug for the treatment of intermittent claudication.

Adult↗
PubMed1988

Drug treatment of intermittent claudication: a critical analysis of the methods and findings of published clinical trials, 1965-1985.

1. All trials of drug therapy for intermittent claudication published in English during the period 1965-1985 were reviewed. A total of 75 trials had studied 33 different pharmacological agents. Treadmill exercise, the most reproducible method of evaluating symptoms in this condition, was used in 49% of trials. 2. Oxpentifylline was the drug that had been most frequently studied. In seven placebo-controlled trials the average response to oxpentifylline, compared with placebo and weighted for sample-size, was 65% improvement in claudication distance. There was, however, a significant negative relation between sample-size and response (rs = -0.79, P less than 0.05), suggesting that this estimate was likely to have been biased by non-publication of negative results. 3. One third of all trials were uncontrolled; 84% of these reported benefit from drug treatment, compared with 32% of placebo-controlled trials (P less than 0.001). Sample-sizes varied from seven to 227 patients; 31% of trials reported data from less than 20 patients and these were likely to have had insufficient statistical power. 4. Overall, 57 of the 75 trials (76%) had at least one of the following deficiencies: an uncontrolled design; not double-blind; failure to use treadmill exercise; less than 20 patients included in the analysis. Thus, a priori three-quarters of all trials were unlikely to have made a satisfactory assessment of drug efficacy. 5. The information available does not establish convincingly that any drug consistently improves exercise performance in intermittent claudication. In view of the deficiencies in previous trials, we propose guidelines for future studies with regard to trial design, sample-size and methods of exercise testing.

Clinical Trials as Topic↗