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Does supervised exercise offer adjuvant benefit over exercise advice alone for the treatment of intermittent claudication? A randomised trial.

OBJECTIVE: Exercise advice is the main treatment for symptom relief in the UK for patients with mild to moderate Intermittent Claudication (IC). Would a weekly exercise and motivation class for 6 months offer adjuvant benefit over written and verbal exercise advice alone? PATIENTS AND METHODS: Fifty-nine patients attending a regional vascular centre for whom IC was the main factor affecting mobility were randomised to either exercise advice alone (n=30) or exercise advice with a once a week 45 min supervised exercise/motivation class (n=29). The mean age was 68 years. Baseline and 6-month assessment included a Quality of Life Questionnaire--the Short-Form-36, the Charing Cross Symptom Specific Claudication Questionnaire (CCCQ) and treadmill walking distance (3.5 km/h 12%). RESULTS: At 6-month follow-up the supervised exercise group had improved their treadmill walking by 129% compared to 69% in the advice alone group (p=0.001). This significant improvement was maintained at the subsequent 9 and 12-month follow-up assessments. By the 9-month stage the advice only group CCCQ score had improved 16% from baseline, while the supervised exercise group had a significantly better 43% improvement in base line score (p<0.05). Self reported frequency of walks was higher in the exercise class group being significant for improvement in CCCQ score. CONCLUSION: A weekly, supervised exercise and motivation class for a 6-month period provides a significant improvement in patients' symptoms, quality of life, and distance walked compared with advice alone and this improvement continues after attendance at class has ceased.

Aged↗

Treatment of long-distance intermittent claudication with pentoxifylline: a 12-month, randomized trial.

The efficacy, safety, and cost of pentoxifylline (PXF) in long-range (>400 m interval) intermittent claudication was studied comparing PXF and placebo in a 12-month study. A standardized treadmill test was performed at inclusion and at 6 and 12 months. A training plan based on walking was associated with the control of risk factor levels. Of the 194 included patients, 135 completed the study: 75 in the PXF group and 60 in the placebo group. There were 59 dropouts (due to low compliance). The authors observed a 148% increase in total walking distance (TWD) at 6 months with PXF (vs 110% with placebo; p<0.05); at 12 months, the increase was 170% with PXF (vs 131% with placebo; p<0.02). There was a 38% difference at 6 months and 39% at 12 months in favor of PXF. Treatment was well tolerated. In conclusion, PXF improved walking distance significantly better than placebo.

Aged↗

High density lipoprotein cholesterol and arteriography in intermittent claudication.

Overnight fasting plasma lipoprotein and lipid concentrations were measured in a group of 76 patients with peripheral arterial disease (PAD)--main symptom: intermittent claudication--and compared to those of 21 controls, matched with the patients according to age, sex, body-mass index, alcohol and tobacco consumption, but without any signs of peripheral arterial disease. Significantly lower median values of high density lipoprotein cholesterols (HDL-C) (P less than 0.01), and significantly higher median values of low density lipoprotein cholesterols (LDL-C) (P less than 0.05) were found in the PAD group. The results also showed significantly lower ratios of HDL-C/LDL-C and HDL-C/total cholesterol in the PAD group when compared to the controls (both P less than 0.005). No significant differences were demonstrated concerning very low density lipoprotein, total cholesterol, or triglyceride plasma concentrations. Evaluation of arteriograms showed a significant negative correlation between HDL-C concentrations and the extent of arteriosclerotic lesions in the lower extremities (P less than 0.05). Thus, not only were the HDL-C and LDL-C levels different in the PAD group, but we also found a correlation between HDL-C and the severity of vascular disease.

Adult↗

[Intermittent claudication. Introduction to clinical diagnosis].

The history and the physical examination are still at the basis of the approach of the patient suffering from intermittent claudication. The history makes clear the specific symptom and its localization. The evolution of the disease, the social and professional handicap are defined. Other troubles and other localizations of the vascular disease are recognized and the nature of the risk factors etablished. The physical examination indicates the pattern and the distribution of the vascular lesions and orientates the pathogenic investigations. A rough assessment of the insufficiency of the cutaneous and muscular circulation is also possible.

Humans↗

The effect of cigarette smoking status on six-minute walk distance in patients with intermittent claudication.

The purposes of the study were threefold: (1) to compare 6-minute walk performance as a measure of exercise tolerance among three different groups of peripheral arterial occlusive disease (PAOD) patients with intermittent claudication-current smokers, former smokers, and patients who have never smoked; (2) to identify important covariates that might affect the relationship between smoking and exercise in the PAOD population; (3) to determine whether differences among the three groups in 6-minute walk performance persist after statistically controlling for the significant covariates. Recruited into the study were 415 PAOD patients with intermittent claudication between the ages of 42 and 88 years. The self-reported smoking status consisted of 182 current smokers, 196 former smokers, and 37 patients who had never smoked. The authors recorded 6-minute walk distance, a reliable measurement of exercise tolerance in PAOD patients, as well as age, body composition, self-reported ambulatory function, self-reported physical activity, and standard peripheral hemodynamics. Nonsmokers walked significantly farther (413 +/- 14 m; mean +/- standard error) and took more steps (665 +/- 14 steps) than either current (352 +/- 7 m; 563 +/- 9 steps) or former smokers 370 +/- 7 m; 600 +/- 8 steps) (p<0.05). The nonsmokers had a higher ankle-brachial index (ABI) value (0.70 +/- 0.03) than patients who actively smoked 0.62 +/- 0.01 (p<0.03); the authors observed an inverse relationship between smoking history and self-reported physical activity (WIQ Distance Score: nonsmokers 51 +/- 6%, former smokers 38 +/- 3%, and smokers 32 +/- 2%) (p<0.01). From a multivariate perspective, ABI, physical activity, and perceived walking ability were the only independent predictors of 6-minute walk distance. Differences in the adjusted 6-minute walk distance among the nonsmokers (388 +/- 13 m), current smokers (359 +/- 6 m), and former smokers (368 +/-6 m) no longer remained after controlling statistically for these covariates. The findings suggest that 6-minute walk distance is a sensitive measure to detect differences in submaximal exercise performance between smoking and nonsmoking PAOD patients with intermittent claudication. Moreover, the group difference in the 6-minute walk distance is explained by group differences in walking perception, PAOD severity, and physical activity level.

Adult↗

Intermittent claudication -- atypical presentation, diagnosis and treatment.

A unique case of a man with Fabry's disease and associated small vessel vasculopathy manifesting as recurrent episodes of intermittent claudication is described. The case highlights the concept that microvascular involvement due to local accumulation of glycosphingolipid in the smooth muscle fibres of vessel walls may be responsible for claudicant symptoms in such patients rather than the more classical macrovascular insufficiency.

Endothelial Cells↗

The acute effects of cigarette smoking on treadmill exercise distances in patients with stable intermittent claudication.

The hypothesis that smoking has an acute effect on treadmill exercise performance in patients with peripheral vascular disease was investigated in a crossover trial. Twelve patients with stable intermittent claudication who were regular smokers attended on two occasions within one week and treadmill tests were performed after 1/2, 1, 1 1/2, and 2 hours. Immediately before the second exercise test, two standard cigarettes were smoked or an unlit cigarette was "sham-smoked." Because participants could not be blinded, an attempt to control for patient bias was made. Half were told that we expected smoking to make no difference or possibly cause some improvement, and half were told that we expected it to make no difference or possibly cause some deterioration. These explanations and the order of study days were determined by balanced randomization. Suggestion had a significant influence on claudication distance immediately after smoking (p less than 0.01) but no significant effect on walking distance. Combining data from both groups assumes that no overall bias was introduced by the explanations given. Immediately after smoking, small, nonsignificant increases in claudication distance (+10%, 95% CI-7%, +27%) and walking distance (+9%, 95% CI-2%, +19%) were observed. Smoking caused a mean increase in heart rate of 9 beats per minute, which persisted for one hour, but no consistent change in blood pressure. The results show that suggestion may have a significant influence on treadmill exercise distances. Smoking is unlikely to have an important acute effect on exercise performance in claudicants.

Adult↗

Double-blind, controlled, multicenter study of indobufen versus placebo in patients with intermittent claudication.

The objective of the study was to evaluate the efficacy and safety of indobufen compared with placebo in the treatment of moderately severe intermittent claudication. The study consisted of a four-week single-blind, placebo-controlled run-in phase, followed by a six-month double-blind randomized treatment period. A total of 302 patients were allocated to treatment with either placebo (154 patients) or indobufen (148) 200 mg twice daily. The results of the overall intention-to-treat analysis of the study population showed statistically significant superiority of indobufen over placebo after six months for both the initial (ICD) and absolute claudication distances (ACD). The ICD before treatment with indobufen or placebo averaged 137.9 +/- 68.2 and 136.6 +/- 63.2 m (mean +/- SD), respectively. After six months' treatment with active drug or placebo, this parameter reached 227.9 +/- 174.4 and 153.1 +/- 86.8 m (mean +/- SD), respectively (p < 0.01). Similar results were obtained on ACD. The reduction of lower limb symptoms also suggested a greater clinical benefit in the indobufen-treated patients. There was no significant change in either group in the ankle/arm pressure ratio at the end of treatment. Adverse events of any type were reported by 18 patients (12.2%) in the indobufen group and by 11 patients (7.2%) in the placebo group. The mechanism whereby the drug is effective in this clinical condition could be related to both its antiplatelet and hemorheologic effects.

Double-Blind Method↗

Intermittent claudication: factors determining outcome.

Two groups of patients were followed up for four to eight years after first referral or admission to hospital for intermittent claudication (IC) in a study of the natural history of the disease and of factors determining its outcome. In one series of 60 patients, those who stopped or reduced smoking after referral had a much improved prognosis. Thus even after the diagnosis of IC it is extremely important that patients should be encouraged to stop smoking, since this correctable factor appears to be of greater importance in determining outcome than other medical risk factors for the disease that are less amenable to treatment. In the second study, 160 patients were followed up for eight years after first hospital admission. They had a total of 480 hospital admissions and had spent 11 190 days in hospital; their life expectancy after the age of 60 was about half that of the general population. Age, coronary artery disease, cerebrovascular disease, and diabetes were associated with an adverse outcome.

Adult↗

The Oslo balloon angioplasty versus conservative treatment study (OBACT)--the 2-years results of a single centre, prospective, randomised study in patients with intermittent claudication.

OBJECTIVES: To compare the effect of optimal medical treatment only (OMT) with OMT combined with percutaneous transluminal angioplasty (OMT+PTA) in patients with intermittent claudication (IC). DESIGN: A single centre prospective, randomised study. Quality of life (QoL) was the primary outcome measure. Secondary measures were ankle-brachial-index (ABI), treadmill walking distances and mortality. METHODS: From a total of 434 patients considered for inclusion into the trial, only 56 patients with disabling IC fulfilled the inclusion criteria. The patients were randomised into treatment groups consisting of 28 patients each and followed for 2 years. ABI and treadmill walking distances were measured in addition to the visual analogue scale (VAS) for pain evaluation, and QoL assessment using the Short Form (SF-36 and Claudication Scale (CLAU-S). RESULTS: The demographic data in the 2 groups were almost identical. After 2 years of follow-up the ABI, the treadmill walking distances and the VAS were significant improved in the group treated with OMT+PTA, compared to the group treated with OMT only (p<0.01 for all). Furthermore, some variables from the QoL assessment also showed a significant improvement in favour of the OMT+PTA group (p<0.05 for all). CONCLUSION: The advantage of conducting a single centre study and adhering to very strict inclusion criteria was illustrated by the homogenous demographic data of the two groups. This partly outweighed the disadvantage of having included a relatively small number of patients. Early intervention with PTA in addition to OMT seems to have a generally more positive effect compared to OMT only, on haemodynamic, functional as well as QoL aspects during the first 2 years in patients with IC.

Aged↗

Episodes of ST-segment depression is related to changes in ambulatory blood pressure and heart rate in intermittent claudication.

OBJECTIVE: To study the prevalence and circadian distribution of ischaemic ST-segment depression detected with ambulatory electrocardiographic monitoring (AECG) in patients with intermittent claudication (IC) as well as to study ambulatory blood pressure (ABP) and the relation of ischaemic episodes to variations in ABP and heart rate. DESIGN: A total of 40 patients with a history of IC and an ankle/brachial-index (ABI) <0.9 performed: (i) 24-h AECG recordings, (ii) simultaneous 24 h recordings of ABP every 15 min (Spacelabs 90207), (iii) an exercise treadmill test (ETT). An ischaemic episode was defined as a transient ischaemic ST-segment deviation > or =1 mm lasting >1 min. Eleven patients were excluded from ECG analysis because of uninterpretable ECG caused by treatment with digoxin or technical problems. RESULTS: Out of 29 patients, eight experienced a total of 15 episodes of ST-depression on AECG. The mean duration was 21+/-31 min. The majority of episodes (11 of 15) occurred between 6 and 12 a.m. In eight patients with ST-segment depression three had a history of ischaemic heart disease (IHD), four were hypertensives and four had signs of myocardial ischaemia on ETT. There were no significant differences between patients with and without ST-segment depression in ABP, walking performance or ABI. During ST-depression episodes systolic and diastolic blood pressure and heart rate were higher than day mean values; 178+/-41 vs. 166+/-30 mmHg (P= 0.09); 96+/-9 vs. 90+/-4 mmHg (P = 0.01) and 103+/-9 vs. 87+/-5 beats min(-1) (P < 0.01). CONCLUSION: Silent myocardial ischemia occurred in about a third of patients with IC. Episodes of ischaemia were associated with an increased ABP and heart rate. Whether treatment of high blood pressure may reduce silent ischaemia and if this favourably influences outcome is a matter of further research.

Aged↗

A randomised, double blind, placebo-controlled study to determine the efficacy of immune modulation therapy in the treatment of patients suffering from peripheral arterial occlusive disease with intermittent claudication.

OBJECTIVES: this study examined the effect of immune modulation therapy (IMT) on claudication distances. MATERIALS AND METHODS: a double-blind placebo controlled trial was performed on patients with disabling intermittent claudication with randomisation stratified for short and long distance IC. For IMT, following exposure to UV light, oxidisation and 42.5 degrees C, 10 ml of citrated autologous blood was administered by intra-muscular injection. One course consisted of 6 injections in 3-weeks followed by 3-weeks rest. Patients received 2, 3 or 4 courses depending on response. The primary end-point was the number of responders (>50% increase in initial claudication distance (ICD)) in each group. Secondary end-points included percentage changes in ICD and change in quality of life. RESULTS: at week 24, there were more responders in the IMT group (20/31, 65%) compared to placebo (16/39, 41%) (p=0.06). In the subgroup of short distance claudicants this difference reached significance (IMT 17/26, 65%) (Placebo 12/33, 36%) (p=0.04). The median increase in ICD was significantly greater in the IMT group (81%) compared to placebo (44%, p=0.04). These results were supported by quality of life measurements. CONCLUSIONS; IMT is a safe and apparently effective treatment for patients with short distance claudication.

Aged↗

Platelet survival, atherosclerotic intermittent claudication and ticlopidine.

Platelet survival times were measured twice within 6 months using autologous 111-Indium-labelled platelets in 13 male patients diagnosed as stable intermittent claudicants. Linear, exponential, weighted mean and gamma function (multiple-hit) analyses were carried out on the data. Of these methods, exact mathematical models such as linear and exponential are unsuitable for the comparison of curves which may alter with treatment or disease progression. Weighted mean platelet survival correlated (r = 0.96) with platelet survival calculated by the precision reference method of analysis, gamma function. Statistics were expressed from gamma function analyses unless otherwise stated. Severity of claudication was measured by doppler; the ratio of brachial to mean ankle pressures was directly related to platelet survival (r = 0.84). In 7 patients, where duration of claudication was greater than 5 years, platelet survival was significantly reduced (P less than 0.02) compared with 6 newly diagnosed claudicants of less than 18 months duration. Six randomly selected patients were treated with 250 mg b.d. ticlopidine during one of the study periods. Ticlopidine significantly increased platelet survival (P less than 0.02) in all patients irrespective of disease duration or severity. The involvement of platelets in atherosclerosis observed in these claudicants, can be reduced by therapy with ticlopidine, however, the lack of clinical improvement following long-term drug treatment only confirms the platelet's secondary role in this disabling disease.

Aged↗

Beta-adrenergic blocking agents and intermittent claudication: systematic review.

To clarify contradictions in past reports and the package inserts for beta-adrenergic blocking agents (beta-blockers) for patients with intermittent claudication (IC), we investigated the effects of beta-blockers in patients with IC using the systematic review technique. Data sources were randomized, controlled trials that investigated the effects of beta-blockers compared with the placebo or untreated group (controls) in patients with IC. Primary endpoints were walking distance and walking time, and secondary endpoints were ankle-brachial index (ABI) and calf blood flow. Nine trials were included in the analysis. Meta-analysis showed that there was a significant worsening in maximal walking distance and initial claudication distance in patients receiving beta-blockers, with standardized mean differences of -0.31 and -0.39 (95% confidence interval -0.58 to -0.04 and -0.73 to -0.06, P=0.03 and 0.02, respectively) compared with controls. There were no significant differences in maximal walking time (0.07, -0.24 to 0.37), time to onset of claudication (0.12, -0.23 to 0.47), ABI at rest (0.24, -0.30 to 0.78), calf blood flow at rest (0.00, -0.26 to 0.25), and calf blood flow after exercise (-0.23, -0.69 to 0.22). However, only one trial evaluated ABI, and the number of cases is increasing, suggesting that beta-blockers do not worsen ABI. There was no evidence that beta-blockers prescribed for patients with IC have unsuitable "precautions" in the package inserts. However, reluctance to administer beta-blockers to patients because they have IC is not appropriate.

Adrenergic beta-Antagonists↗

Epidemiology of intermittent claudication: evaluation of risk factors.

Information from a geriatric health screening programme (Dunedin Program) was used to study the prevalence and risk factors predisposing to intermittent claudication (IC) in 1704 ambulatory elderly subjects. Risk factors studied included reported symptoms and diseases, mediation use, haematological and biochemical findings. The prevalence of IC reported by Dunedin participants was 14.1% for women and 14.4% for men. There was a positive relationship between IC and the number of other diseases and symptoms reported (P less than 0.0001). Serum glucose, cholesterol, and triglycerides were significantly higher in subjects reporting IC. Systolic blood pressure was higher in men and women reporting IC, but no significant relationship was observed with diastolic blood pressure.

Aged↗

[Combination of physiotherapeutic exercise therapy with bencyclane in intermittent claudication (author's transl)].

Earlier investigations had shown that an intensive physiotherapy program with 30 treatments in 6 weeks was the most rational therapy for intermittent claudication, but the question whether the therapeutic success could be improved by the addition of "vasoactive" substances remained open. For this reason, bencyclane was added to the basic physiotherapy in a double blind trial involving 109 ambulant patients. 91 or these were evaluated. The treatment group (n = 45) showed a greater increase in walking distance of 21.7% compared with the placebo group (n = 46). Also in the evaluation of the therapeutic success rate, the treatment group showed better results (84.4%) than the placebo group (71.7%). From this it can be concluded that the basic physiotherapy can be effectively supported with bencyclane.

Adult↗

[The treatment of intermittent claudication by physical retraining of the non-hospitalised patient. Evaluation of effectiveness in a group of 40 patients (author's transl)].

The treatment of intermittent claudication by physical re-training of a patient with lower limb arteriopathy is not new (Alpert 1969, Cachovan 1976, Kindler 1965, Schoop 1964). It gives an effective improvement of walking distance and of physical performance capacity. Most programs used need the patient to be kept in an hospital and thus entail a significant social cost. We have set up a program for the retraining of patients that are not hospitalized and have checked the short and long term action achieved. The walking distance, the maximum performance in specifical exercises, the walking exercises on a tread mill, are studied during the clearance X133, the total leg blood flow before and after an arterial occlusive hyperhemic test is studied simultaneously.

Ambulatory Care↗

[Lipoprotein(a) and Apo-A isoforms in patients with intermittent claudication].

AIM: To study a correlation between lipoprotein(a) [LP(a)], as well as the phenotype of apoprotein(a) [apo(a)] and the presence of intermittent claudication (IC). MATERIALS AND METHODS: The study included 25 patients (9 females, 16 males; mean age, 63.4 +/- 8.2 years) and 50 individuals (21 females, 29 males; mean age, 61.3 +/- 6.1 years) of a control group. RESULTS: In the patients, the level of LP(a) was 3 times higher than in the controls (median 39 and 13 mg/dl, respectively; p < 0.01). The low molecular-weight phenotypes of apo(a) occurred significantly more frequently in the patients than those in the controls (62 and 28%, respectively; p = 0.02). CONCLUSION: Multifactorial analysis has shown that the level of Lp(a) is an independent and important factor associated with the presence of IC.

Aged↗