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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↗
PubMed1994

Transcutaneous oxygen pressure measurements in patients with intermittent claudication.

Transcutaneous oxygen pressure (TcPO2) measurements were performed on 10 male patients with moderate-to-severe intermittent claudication. The TcPO2 electrode was attached to the dorsum of the foot. TcPO2 response to a standardized treadmill exercise test was evaluated, as was the reproducibility of TcPO2 measurements at rest and during exercise. Reproducibility was assessed using a similar exercise test within 2-5 days. Treadmill exercise induced a marked decrease in TcPO2 in all patients, from 9.3 +/- 0.9 to 2.8 +/- 2.0 kPa. Maximal walking distance was 280 +/- 127 m at the first treadmill test and 272 +/- 113 m at the second. Blood lactate and heart rates at rest and at end of exercise were also unchanged. TcPO2 at rest was highly reproducible, but considerable variation was found for measurements during and after exercise. This variation was most obvious for measurements during exercise and no direct or reproducible relation was found between ischaemic calf pain and TcPO2 values. Post-exercise measurements were slightly more reproducible and somewhat easier to assess. In contrast to standard TcPO2 measurements, total exercise-induced ischaemia expressed as area under the post-exercise TcPO2 curve was highly reproducible. In summary, our results with TcPO2 measurements in patients with intermittent claudication showed a marked exercise-induced decrease in all patients. However, the variation in TcPO2 values when the test was repeated after 2-5 days under stable clinical and circulatory conditions limits its application as a quantitative measure of lower-limb ischaemia. Thus, measurements of area under the TcPO2 curve might be preferred for this purpose.

Aged↗
PubMed1991

Claudication: an unusual side effect of DHE administration.

DHE is effective in the treatment of acute and chronic migraine. The side effects most commonly observed are abdominal discomfort, muscle pain, diarrhea and anxiety. DHE is a dehydrogenated amino acid ergot alkaloid and, as such, causes only limited vasoconstriction; indeed, its overall effects include peripheral vasodilation. The literature is replete with reports of clinical vasospasm and claudication occurring with therapeutic doses of ergotamine. There has not been any previous description of claudication caused by DHE. This paper describes pulselessness in two patients during relatively short courses of DHE. Treatment consisted of calcium channel blockers and discontinuation of DHE. Recovery was complete.

Adult↗
PubMed1980

Intermittent claudication: is a supervised exercise class worth while?

Twenty-one patients (19 men and two women) with disabling exercise-related leg pain attended a physiotherapy department on one afternoon each week for an exercise training programme lasting one month. The clinical diagnosis of intermittent claudication and localisation of the atherosclerotic occlusions were confirmed in all but one case by pulse volume recordings and segmental Doppler systolic pressure measurements. Two patients whose symptoms worsened underwent arterial reconstruction. Post-training assessment at six months showed that the remaining 18 patients walked 80% further and performed 75% more step-ups. They also felt much healthier, having unduly restricted their activities before because they had feared the onset of ischaemic leg pain. These results suggest that supervised exercise training is a simple and effective method of treating patients with intermittent claudication.

Blood Pressure↗
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↗
PubMed1973

Clinical, haemodynamic, rheological, and biochemical findings in 126 patients with intermittent claudication.

Increased blood viscosity has been shown to be an important factor in reducing blood flow in a review and analysis of the history, clinical findings, and haemodynamic, rheological, radiological, and biochemical measurements in 126 patients with intermittent claudication. In some patients increased viscosity seemed to be the determining cause of claudication. A raised plasma fibrinogen was the most common single biochemical abnormality. The results of conventional serum lipid and lipoprotein estimations were abnormal in the series as a whole but did not correlate with clinical findings or flow measurements at individual patient level. There was, however, a significant correlation between some clinical findings and the susceptibility of the red cells to autoxidation.

Adult↗
PubMed2005

Intermittent claudication: functional capacity and quality of life after exercise training or percutaneous transluminal angioplasty--systematic review.

PURPOSE: To systematically review published data about the short- and long-term effects of exercise training and angioplasty on functional capacity and quality of life of patients with intermittent claudication. MATERIALS AND METHODS: Articles published between January 1980 and February 2003 were included if patients had intermittent claudication treated with exercise training or angioplasty and if both functional capacity and quality-of-life scores from Medical Outcomes Study 36-Item Short Form health survey were reported for at least 3 months of follow-up. Data were pooled by using a random effects model and weighted means. Pooled results were compared between the treatment groups by using the chi2 test and the Student t test (alpha = .05, two sided). RESULTS: In the analyses, five studies (202 patients) were included in the exercise group, and three studies (470 patients), in the angioplasty group. At 3 months of follow-up, the ankle-brachial index was significantly improved in the angioplasty group (mean change, 0.18; P < .01) but not in the exercise group (mean change, 0.01; P = .29). At 3 months, quality of life was significantly improved with regard to ratings of physical functioning and bodily pain in the exercise group (mean change, 18 and 10, respectively; P < .01) and physical role functioning in the angioplasty group (mean change, 30; P = .03). Mean change in ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months (P < .01); mean change in quality-of-life scores did not. CONCLUSION: Improvement in quality of life was demonstrated after both exercise training and angioplasty, whereas functional capacity showed significant improvement after angioplasty. The ankle-brachial index significantly differed between the two treatment groups at 3 and 6 months, whereas the quality-of-life scores did not.

Angioplasty, Balloon↗
PubMed1991

Exercise-induced variations in muscle tissue oxygen pressure in claudicants: effects of buflomedil.

The amount of oxygen actually supplied to the ischemic muscle tissue of patients with intermittent claudication was quantified before and after a standardized pedal ergometric test. Muscle tissue pO2 was measured with micro-platin needle electrodes directly in the lower limb muscles at rest and 3, 10, 20 and 60 min after a 4-min work load. Time-dependent variations in the behavior of pO2 values as well as changes in the shapes of pooled pO2 histograms make it possible to monitor the effect of therapeutic measures. In claudicants (stage IIb) with ascertained occlusions or stenosis of the femoral artery or the pelvis region, it was demonstrated that the delayed increase in tissue pO2 after exercise could be improved by the infusion of 400 mg buflomedil. Comparison between the time-related pooled histograms confirmed improvement of oxygen supply under the influence of this drug.

Adult↗
PubMed2003

Regional angiogenesis with vascular endothelial growth factor in peripheral arterial disease: a phase II randomized, double-blind, controlled study of adenoviral delivery of vascular endothelial growth factor 121 in patients with disabling intermittent claudication.

BACKGROUND: "Therapeutic angiogenesis" seeks to improve perfusion by the growth of new blood vessels. The Regional Angiogenesis with Vascular Endothelial growth factor (RAVE) trial is the first major randomized study of adenoviral vascular endothelial growth factor (VEGF) gene transfer for the treatment of peripheral artery disease (PAD). METHODS AND RESULTS: This phase 2, double-blind, placebo-controlled study was designed to test the efficacy and safety of intramuscular delivery of AdVEGF121, a replication-deficient adenovirus encoding the 121-amino-acid isoform of vascular endothelial growth factor, to the lower extremities of subjects with unilateral PAD. In all, 105 subjects with unilateral exercise-limiting intermittent claudication during 2 qualifying treadmill tests, with peak walking time (PWT) between 1 to 10 minutes, were stratified on the basis of diabetic status and randomized to low-dose (4x10(9) PU) AdVEGF121, high-dose (4x10(10) PU) AdVEGF121, or placebo, administered as 20 intramuscular injections to the index leg in a single session. The primary efficacy end point, change in PWT (DeltaPWT) at 12 weeks, did not differ between the placebo (1.8+/-3.2 minutes), low-dose (1.6+/-1.9 minutes), and high-dose (1.5+/-3.1 minutes) groups. Secondary measures, including DeltaPWT, ankle-brachial index, claudication onset time, and quality-of-life measures (SF-36 and Walking Impairment Questionnaire), were also similar among groups at 12 and 26 weeks. AdVEGF121 administration was associated with increased peripheral edema. CONCLUSIONS: A single unilateral intramuscular administration of AdVEGF121 was not associated with improved exercise performance or quality of life in this study. This study does not support local delivery of single-dose VEGF121 as a treatment strategy in patients with unilateral PAD.

Adenoviridae↗
PubMed1981

The arm-ankle pressure gradient in relation to cardiovascular risk factors in intermittent claudication.

The arm-ankle systolic pressure gradient was measured in 165 male patients with intermittent claudication and was correlated with different combinations of known cardiovascular risk factors. The pressure gradient increased with increasing number of risk factors. We conclude that intermittent claudication may be used as a simple model for studies of arteriosclerosis, the arm-ankle systolic pressure gradient being a measure of the degree of arteriosclerosis between heart and ankle.

Adult↗
PubMed1987

Intermittent claudication, exercise, and blood rheology.

Forty-two stable patients with claudication were assigned to two groups. Group I (n = 22) was submitted to regular, standardized treadmill exercise for 2 months. During this time the maximal and pain-free walking distances increased significantly (more than 100%). Group II (n = 20) patients did not exercise over the same period of time, and their walking distances remained essentially unchanged. No drugs or other forms of treatment were given in either group. The rheology of blood, as quantified by blood and plasma viscosity, hematocrit, blood filterability, and red cell aggregation, was initially abnormal in patients as compared with matched controls. Blood and plasma viscosity, blood cell filterability, and red cell aggregation normalized significantly in group I, but remained pathologic in group II. The hemorrheologic values of patients after 2 months of exercise did no longer differ significantly from those of healthy controls. The "fluidification" of blood induced by regular exercise was qualitatively and quantitatively similar to that obtainable by hemorrheologically active medications. The results confirm that physical training is clinically effective in patients suffering from claudication. They furthermore suggest that training may be looked on as a form of "hemorrheologic therapy" suitable for increasing the fluidity of blood in patients with ischemic diseases. Part of the benefits of regular exercise in stage II occlusive peripheral arterial disease may result from changes in hemorrheology; further studies are needed to define the mechanism.

Aged↗
PubMed1996

Carnitine-related alterations in patients with intermittent claudication: indication for a focused carnitine therapy.

BACKGROUND: Carnitine metabolism is altered in peripheral arterial disease. L-carnitine supplementation may correct these alterations and improve walking performance. METHODS AND RESULTS: Plasma levels of carnitine and its esters were measured at rest and after maximally tolerated exercise in 22 claudicant patients and 8 normal subjects. One week later, this protocol was repeated in patients after random administration of placebo or L-carnitine (500 mg IV as a single bolus). Two groups of patients emerged. In 10 patients (group IC1), the plasma level of acetylcarnitine at rest was 3.7 +/- 0.2 micromol/L and increased significantly (P<.01) at maximally tolerated exercise. In 12 patients (group IC2), the resting level of plasma acetylcarnitine was elevated (7.9 +/- 0.7 micromol/L, P<.01) and decreased with exercise. Furthermore, group IC2 patients had a significantly lower walking capacity than group IC1 patients. In both groups, placebo did not affect the metabolic profile, nor did it improve exercise performance. Conversely, after L-carnitine administration, all but one patient in group IC2 (n=7) showed an increase in plasma acetylcarnitine concentration during exercise versus the decrease observed without L-carnitine. This metabolic effect was accompanied by a significant increase (P<.01) in walking capacity. Interestingly, in group IC1 patients (n=5), L-carnitine neither improved walking capacity nor modified the metabolic profile. Statistical analysis showed that changes in walking capacity with L-carnitine treatment were influenced exclusively by exercise-induced changes in plasma acetylcarnitine. CONCLUSIONS: In patients with intermittent claudication, assessment of plasma acetylcarnitine at rest and after exercise may be a means to select a target population for L-carnitine therapy.

Acetylcarnitine↗
PubMed1997

Effect of verapamil in intermittent claudication A randomized, double-blind, placebo-controlled, cross-over study after individual dose-response assessment.

BACKGROUND: The calcium antagonist verapamil is a vasodilator drug that has been shown to increase oxygen extraction of ischemic tissues in coronary and peripheral vascular disease. METHODS AND RESULTS: Since the balance between the positive and the negative effects of vasodilation may be delicate in ischemic diseases a dose-response study (dose range, 120 to 480 mg) was established to determine optimal, individual dosages of slow-release verapamil in 44 patients with stable intermittent claudication (Fontaine classification stage II) with respect to walking capacity. A randomized, double-blind, placebo-controlled, cross-over study (4 weeks) was performed to assess clinical and hemodynamic effects of verapamil. The optimal daily dose of verapamil on maximal walking ability was 120 (8 patients), 240 (8 patients), 360 (14 patients), and 480 mg (14 patients). Walking distances were measured at a metronome-controlled speed of 60 steps per minute on level surface. Optimal individual doses of verapamil increased mean pain-free walking distance by 29% from 44.9 to 57.8 meters (P < .01) and maximal walking distance by 49% from 100.7 to 149.8 meters (P < .001) compared with placebo. The increase in maximal walking distance correlated positively only with initial systolic ankle pressure (r = .49, P < .001) and ankle/brachial pressure index (r = .37, P < .013). Verapamil had no effect on systolic ankle pressure, ankle/brachial pressure index, peripheral leg temperature, or blood pressure, which suggests that the drug may have extrahemodynamic effects, possibly brought about through improved oxygen metabolism. CONCLUSIONS: Verapamil showed significant clinical benefits in patients with moderate intermittent claudication in this short-term study. Individual optimization of drug dosage should be considered an option both in trials and in the clinical setting in these patients.

Aged↗
PubMed2000

Relationship between physical activity recall and free-living daily physical activity in older claudicants.

The purposes of this study were to determine the relationship between the physical activity values obtained from the peripheral arterial disease-physical activity recall (PAD-PAR) questionnaire and (1) the free-living daily physical activity obtained from the doubly labeled water technique and (2) clinical measures of PAD severity. Fifty-one older PAD patients (age= 70 +/- 6 years) were recruited from the Vascular Clinic at the Baltimore Veterans Affairs Medical Center and from radio and newspaper advertisements. Energy expenditure of physical activity (EEPA) was determined by using doubly labeled water and indirect calorimetry techniques. PAD severity was measured by ankle/brachial index (ABI) and walking distance to maximal claudication pain determined during a graded treadmill test. In addition, patients were also characterized on body composition and total daily energy expenditure. The physical activity values obtained from the PAD-PAR questionnaire (113 +/- 37 MET-hr/wk) were not related to EEPA (542 +/- 260 kcal/day; r= -0.057, p=0.690), ABI (0.64 +/- 0.19; r=0.032, p=0.826), or distance to maximal claudication pain (376 +/- 229 m; r=-0.054, p=0.731). The authors conclude that the PAD-PAR questionnaire is not an accurate measurement of free-living daily physical activity when compared to EEPA by use of the criterion method of doubly labeled water, and the activity questionnaire measures were poorly correlated with clinical measures of PAD severity.

Activities of Daily Living↗
PubMed1980

Reactive hyperemia in patients with intermittent claudication, and correlation with other diagnostic methods.

The value of blood flow measurements was evaluated in 16 patients with intermittent claudication and in 17 healthy sex and age-matched volunteers. Limb volume was recorded with an ECG-triggered venous occlusion plethysmograph (Periflow, Janssen), and the flow values were automatically plotted on a second channel. Resting blood flow was similar in both groups, but all the parameters from the reactive hyperemia curve in the claudication group were significantly different from those in the control group. The present data are preliminary in this respect. In most patients visual inspection of the curve allows differentiation of normal and abnormal. Variability of the flow parameters is found to be small; the time-to-peak flow varies the most, but gives at the same time the largest different results in both groups. Finally, there is a positive correlation between resting blood flow, peak blood flow, and walking distance. The present results suggest that flow measurements provide valuable and objective information about the degree of functional distress caused by obliterative vascular diseases in the limbs.

Aged↗
PubMed1983

The effect of withdrawal of beta-adrenergic blockade on intermittent claudication.

Twenty-eight patients with intermittent claudication were studied before and one month after withdrawal of treatment with beta-adrenergic blocking drugs for hypertension, coronary heart disease or both. Heart rate, blood pressure, ankle/arm systolic blood pressure ratio and ankle pulse volume recording (PVR) at rest and after treadmill exercise were recorded, as well as walking distance, time of recovery from subjective symptoms, restitution time of pressure ratio and PVR. A control group of 14 patients, whose beta-adrenergic blocking drugs were not withdrawn, was also included. The result can be summarized as showing that withdrawal of beta-blockade was not demonstrably advantageous in patients with intermittent claudication. Significant improvement was observed only during the first month of the trial, a change which was independent of withdrawal of beta-blockade. The relief of subjective symptoms after exercise occurred significantly faster after withdrawal of nonselective beta-blockade. Otherwise, there was no difference between nonselective and cardioselective beta-adrenergic blocking drugs.

Adrenergic beta-Antagonists↗
PubMed1984

Pentoxifylline in the treatment of intermittent claudication of the lower limbs.

Pentoxifylline, a methyl xanthine analogue was evaluated for treatment of intermittent claudication in a double-blind placebo controlled parallel group study in seven centers in the United States. Tests were performed on 128 cases, including 42 who took pentoxifylline (600 mg by mouth daily, increased stepwise to 1200 mg daily at the end of one month) and 40 who took placebo for 24 weeks. Twenty-five patients on pentoxifylline and 21 on placebo were dropped from the study for reasons unrelated to the drug. Walking ability on a treadmill was increased significantly after 2 weeks and remained so throughout the study in the pentoxifylline vs. the placebo group. Ability to walk until first experiencing intermittent claudication was a more sensitive index than the maximum ability to walk. The drug did not cause changes in blood pressure or in heart rate. Other than mild nausea, there were no significant side effects.

Clinical Trials as Topic↗
PubMed1984

Trental 400 in the treatment of intermittent claudication: results of long-term, placebo-controlled administration.

A double-blind, randomized, placebo-controlled long-term clinical study of Trental 400 was carried out, partly under cross-over design, partly as a parallel-group study, in 36 patients suffering from chronic arterial obstructive disorders in the lower limbs, associated with intermittent claudication, in order to evaluate the effectiveness and the safety of this drug administered t.i.d. over a period of 6 months. This controlled period was preceded by a placebo run-in period of 3 months. The clinical results under Trental 400 showed a statistically significant within group improvement of painfree and maximum walking parameters (p less than 0.05) corresponding to an increase to baseline by +96% to +139% respectively and also in comparison to placebo (p less than 0.05). The alterations of walking parameters within the placebo groups, ranging between -25% and +28% were not significant. The subjective parameters (rest pain, paraesthesias, muscular cramps and sensation of heaviness in the legs) paralleled the course of the walking parameters. Under Trental 400, 24 out of 36 patients reported an improvement of these symptoms compared to 7 under placebo. Trental 400 was well tolerated. Minor side effects were mentioned by 7 out of 36 patients. One patient had to stop the drug treatment because of persisting prickling sensation and subsequent insomnia. Drug-related changes in the laboratory findings could not be detected; vital signs varied in function of age, concomitant drug treatments and seasonal factors. The results obtained in these studies suggest Trental 400 as a drug of choice for treating patients with intermittent claudication due to peripheral arterial obstruction according to stage II or III after Fontaine.

Aged↗