Socioeconomic factors predict successful supervised exercise therapy completion.

OBJECTIVE: Supervised exercise therapy (SET) for patients with intermittent claudication (IC) can lower the risk of progression to chronic limb-threatening ischemia and amputation, while preserving and restoring functional status. Despite supporting evidence, it remains underutilized, and among those who initiate programs, attrition rates are extremely high. We hypothesize that socioeconomic factors may represent significant barriers to SET completion. METHODS: Patients with IC referred to SET at a multi-hospital, single-institution health care system (2018-2022) from a prospectively maintained database were retrospectively analyzed. Our primary endpoint was SET program completion and graduation, defined as completion of 36 sessions. Our secondary endpoints were vascular intervention within 1 year of referral and change in ankle-brachial index (ABI). Baseline demographics were assessed using standard statistical methods. Predictors of SET graduation were analyzed using multivariable logistic regression generating adjusted odds ratios (aORs) with 95% confidence intervals (CIs). Change in ABI was analyzed using t-test between subgroups. Reasons for attrition were tabulated. Patient Health Questionnaire-9 (PHQ-9), metabolic equivalent level, Vascular QOL, Duke Activity Status, and ABI were analyzed using paired t-tests across the entire cohort. RESULTS: Fifty-two patients met inclusion criteria: mean age 67.85 ± 10.69 years, 19 females (36.54%), mean baseline ABI of 0.77 ± 0.16. The co-pays for 100% of patients were fully covered by primary and secondary insurance plans. Twenty-one patients (40.38%) completed SET. On multivariable analysis, residence in a ZIP code with median household income <$47,000 (aOR, 0.10; 95% CI, 0.01-0.76; P = .03) and higher body mass index (aOR, 0.81; 95% CI, 0.67-0.99; P = .04) were significant barriers to SET graduation. There were no differences in ABI change or vascular intervention within 1 year between graduates and non-graduates. Non-graduates reported transportation challenges (25.00%), lack of motivation (20.83%), and illness/functional limitation (20.83%) as primary reasons for SET attrition. Metabolic Equivalent Level (P ≤ .01) and Duke Activity Status scores (P = .04) were significantly greater after participating in a SET program. CONCLUSIONS: Although SET participation improves lower extremity and functionality outcomes, only 40% of referred patients completed therapy in our cohort. Our findings suggest that both socioeconomic and functional factors influence the odds of completing SET programs, indicating a need for holistic pre-referral assessment to facilitate enhanced program accessibility for these populations.

Literature review of transcutaneous electrical nerve stimulation in peripheral arterial occlusive disease of the lower limbs.

The therapeutic challenge in peripheral arterial occlusive disease (PAD) is often to increase walking distance, improve pain or heal a wound when PAD is symptomatic. Walking rehabilitation or surgical revascularization techniques are limited. Others strategies as alternatives and/or complementary treatments are needed. Among alternative options, Transcutaneous Electrical Nerve Stimulations (TENS) could be of interest, both for improved walking distance or pain reduction. The Transcutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacological, mini-invasive technique involving transcutaneous electrical stimulation. However, there are other transcutaneous electrical nerve stimulation techniques based on the principle of vagus nerve stimulation with different mechanistics. Trans-auricular Vagus nerve stimulation (Ta-VNS) is another TENS technique (electrode on the external ear) which relies on the anti-inflammatory pathways of efferent and afferent vagal fibers. We propose here to review the literature of mini-invasive electrical stimulations, whatever the anatomical zone concerned, in PAD. METHOD: The aim was to evaluate the use of non-invasive transcutaneous electrical stimulation therapies (regardless of location) in PAD of the lower limbs, whatever the disease grade. A review of the literature was carried out via a search of the MEDLINE/PubMed database from 1975 to 2023. The articles were selected via abstracts by checking (1) medical indications: PAD patients with claudication were retained, excluding neurological or venous claudication, PAD whatever the disease grade (intermittent claudication or critical limb ischemia [CLI]) and (2) non invasive electrical stimulations were considered (neuromuscular electrical stimulation and spinal cord stimulation were excluded) whatever the anatomical site. Non-electrical stimuli such as acupuncture and reflexotherapy were excluded. RESULTS: Only 9 items were selected, including 7 studies with TENS treatment on the calf, one with trans-auricular vagus nerve stimulation and one with electro-acupuncture points of stimulation. CONCLUSION: Even if the mechanisms involved are different, TENS on the calves or in the external ears show an improvement of walking distance in PAD patients with intermittent claudication. The results of the studies show few positive effects in arteriopathy but we should keep vigilant in the technics used since mechanisms are different and not fully understood. Electro-stimulation of the calf and external ear appears to be an easy-to-use and accessible therapeutic option, especially since some PAD patients are still failing to be released from pain, despite the rise of endovascular interventional techniques.

Low-intensity resistance exercise with blood flow restriction for patients with claudication: A randomized controlled feasibility trial.

BACKGROUND: Claudication is a common and debilitating symptom of peripheral artery disease, resulting in poor exercise performance and quality of life (QoL). Supervised exercise programs are an effective rehabilitation for patients with claudication, but they are poorly adhered to, in part due to the high pain and effort associated with walking, aerobic, and resistance exercise. Low-intensity resistance exercise with blood flow restriction (BFR) represents an alternative exercise method for individuals who are intolerant to high-intensity protocols. The aim of this study was to evaluate the feasibility of a supervised BFR program in patients with claudication. METHODS: Thirty patients with stable claudication completed an 8-week supervised exercise program and were randomized to either BFR (n = 15) or a control of matched exercise without BFR (control; n = 15). Feasibility, safety, and efficacy were assessed. RESULTS: All success criteria of the feasibility trial were met. Exercise adherence was high (BFR = 78.3%, control = 83.8%), loss to follow up was 10%, and there were no adverse events. Clinical improvement in walking was achieved in 86% of patients in the BFR group but in only 46% of patients in the control group. Time to claudication pain during walking increased by 35% for BFR but was unchanged for the control. QoL for the BFR group showed improved mobility, ability to do usual activities, pain, depression, and overall health at follow up. CONCLUSION: A supervised blood flow restriction program is feasible in patients with claudication and has the potential to increase exercise performance, reduce pain, and improve QoL. (Clinicaltrials.gov Identifier: NCT04890275).

Moderate dose of dietary nitrate improves skeletal muscle microvascular function in patients with peripheral artery disease.

Peripheral artery disease (PAD) is an atherosclerotic disease characterized by compromised lower-extremity blood flow that impairs walking ability. We showed that a moderate dose of dietary nitrate in the form of beetroot juice (BRJ, 0.11 mmol/kg) can improve macrovascular function and maximal walking distance in patients with PAD. However, its impacts on the microcirculation and autonomic nervous system have not been examined. Therefore, we investigated the impacts of this dose of dietary nitrate on skeletal muscle microvascular function and autonomic nervous system function and further related these measurements to 6-min walking distance, pain-free walking distance, and exercise recovery in patients with PAD. Patients with PAD (n = 10) ingested either BRJ or placebo in a randomized crossover design. Heart rate variability, skeletal muscle microvascular function, and 6-min walking distance were performed pre- and post-BRJ and placebo. There were significant group × time interactions (P < 0.05) for skeletal muscle microvascular function, 6-min walking distance, and exercise recovery, but no changes (P > 0.05) in heart rate variability or pain-free walking distance were noted. The BRJ group demonstrated improved skeletal muscle microvascular function (∆ 22.1 ± 7.5 %·min-1), longer 6-min walking distance (Δ 37.5 ± 9.1 m), and faster recovery post-exercise (Δ -15.3 ± 4.2 s). Furthermore, changes in skeletal muscle microvascular function were positively associated with changes in 6-min walking distance (r = 0.5) and pain-free walking distance (r = 0.6). These results suggest that a moderate dose of dietary nitrate may support microvascular function, which is related to improvements in walking distance and claudication in patients with PAD.

Rivaroxaban with Aspirin Versus Aspirin for Peripheral Arterial Disease and Intermittent Claudication. Rationale and Design of the COMPASS CLAUDICATION Trial.

BACKGROUND: The COMPASS trial demonstrated that in patients with peripheral arterial disease, the combination of rivaroxaban and aspirin compared with aspirin reduces the risk of major adverse limb events, but it is not known whether this combination can also improve symptoms in patients with intermittent claudication. The primary objective of this study is to evaluate the effect of the combination on claudication distance. STUDY DESIGN: Eighty-eight patients with intermittent claudication will be randomized to receive rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once daily for 24 weeks. The primary outcome is the change in claudication distance from the baseline to 24 weeks, measured by 6 min walking test and treadmill test. The primary safety outcome is the incidence of major bleeding and clinically relevant non-major bleeding according to the International Society on Thrombosis and Hemostasis criteria. SUMMARY: The COMPASS CLAUDICATION trial will provide high-quality evidence regarding the effect of the combination of rivaroxaban and aspirin on claudication distance in patients with peripheral arterial disease.

Body mass-normalized moderate dose of dietary nitrate intake improves endothelial function and walking capacity in patients with peripheral artery disease.

Peripheral artery disease (PAD) is characterized by the accumulation of atherosclerotic plaques in the lower extremity conduit arteries, which impairs blood flow and walking capacity. Dietary nitrate has been used to reduce blood pressure (BP) and improve walking capacity in PAD. However, a standardized dose for PAD has not been determined. Therefore, we sought to determine the effects of a body mass-normalized moderate dose of nitrate (0.11 mmol nitrate/kg) as beetroot juice on serum nitrate/nitrite, vascular function, walking capacity, and tissue oxygen utilization capacity in patients with PAD. A total of 11 patients with PAD received either nitrate supplement or placebo in a randomized crossover design. Total serum nitrate/nitrite, resting BP, brachial and popliteal artery endothelial function (flow-mediated dilation, FMD), arterial stiffness (pulse-wave velocity, PWV), augmentation index (AIx), maximal walking distance and time, claudication onset time, and skeletal muscle oxygen utilization were measured pre- and postnitrate and placebo intake. There were significant group × time interactions (P < 0.05) for serum nitrate/nitrite, FMD, BP, walking distance and time, and skeletal muscle oxygen utilization. The nitrate group showed significantly increased serum nitrate/nitrite (Δ1.32 µM), increased brachial and popliteal FMD (Δ1.3% and Δ1.7%, respectively), reduced peripheral and central systolic BP (Δ-4.7 mmHg and Δ-8.2 mmHg, respectively), increased maximal walking distance (Δ92.7 m) and time (Δ56.3 s), and reduced deoxygenated hemoglobin during walking. There were no changes in PWV, AIx, or claudication (P > 0.05). These results indicate that a body-mass normalized moderate dose of nitrate may be effective and safe for reducing BP, improving endothelial function, and improving walking capacity in patients with PAD.

A systematic review of the role of heat therapy for patients with intermittent claudication due to peripheral artery disease.

Intermittent claudication (IC) is associated with impairments in quality of life and walking ability. Heat therapy is an emerging cardiovascular therapy, which may improve walking in patients with IC. We undertook a systematic review to establish current evidence for heat therapy for patients with IC. We searched five databases (Ovid Medline / PubMed, Embase, Scopus / Web of Science, Cochrane Library and Health Technology Assessment Databases). A total of 6751 records were screened with 76 full-text articles assessed for eligibility. We included three randomised control trials and three acute interventions. For chronic interventions, three different heat therapy interventions were used. The 6-minute walk distance significantly improved following whole-body immersion (p = 0.03; ES 0.94, 95% CI: 0.06-1.82), but not after Waon therapy or a water-perfused garment. Ankle-brachial pressure indices were significantly improved following whole-body immersion (p = 0.01; ES 1.10, 95% CI: 0.20-1.99) but not after other therapies. No form of heat therapy demonstrated statistical improvements in quality of life or brachial blood pressure. Acute interventions were characterised by large increases in limb blood flow and core temperature, and transient reductions in blood pressure post-heating. At present there are only three randomised controlled trials assessing heat therapy for patients with IC. Moreover, each of those randomised controlled trials utilised different heat therapies. There is also very limited study of the acute physiological responses to different heat therapy interventions in these populations. Future research should establish appropriate heat therapy protocols and implement more randomised trials to understand its effectiveness. PROSPERO: CRD42020187941.

A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease.

Lower extremity peripheral artery disease (PAD) induces an ischemic pain in the lower limbs and leads to walking impairment. Electrical stimulation has been used in patients with PAD, but no systematic review has been proposed to address the efficacy of the technique as a treatment for walking impairment in PAD. A systematic search was performed to identify trials focused on electrical stimulation for the treatment of walking impairment in patients with PAD in the Cochrane Central Register, PubMed, Embase, and the Web of Science. Studies were included where the primary outcomes were pain-free walking distance and/or maximal walking distance. When appropriate, eligible studies were independently assessed for quality using the Cochrane Collaboration's tool for assessing risk of bias. Five studies eligible for inclusion were identified, of which only two were randomized controlled studies. Trial heterogeneity prevented the use of the GRADE system and the implementation of a meta-analysis. Three types of electrical stimulation have been used: neuromuscular electrical stimulation (NMES, n = 3), transcutaneous electrical stimulation (n = 1), and functional electrical stimulation (n = 1). The two available randomized controlled studies reported a significant improvement in maximal walking distance (+40 m/+34% and +39 m/+35%, respectively) following a program of NMES. Owing to the low number of eligible studies, small sample size, and the risk of bias, no clear clinical indication can be drawn regarding the efficacy of electrical stimulation for the management of impaired walking function in patients with PAD. Future high-quality studies are required to define objectively the effect of electrical stimulation on walking capacity.

Effectiveness of the Combined Treatment of Functional Electrical Stimulation and Deambulation in Diabetic Arteriopathy.

OBJECTIVE: To determine whether functional electrical stimulation (FES) is able to improve ischemic pain and quality of life of patients with diabetic arteriopathy (DA) in grade-IIa Leriche-Le Fontaine. MATERIAL AND METHODS: This is a single-blinded, randomized, prospective cohort study. We included patients diagnosed with grade-IIa Leriche-Le Fontaine peripheral arterial disease in both lower extremities with and without diabetes mellitus (DM). The ankle-brachial index was 0.4-0.9. Patients were randomized into two experimental groups: nondiabetic (non-DM) (n = 71) and diabetic (DM) (n = 71). The patients received FES while walking for 1 hr on a supervised treadmill. Three months of follow-up were conducted after treatment. RESULTS: A total of 168 patients were randomized; 142 completed the study, with 71 in each group. Both groups reported an improvement after the treatment, but the improvement was statistically significant in the DM group, in which all the parameters studied improved. Greater benefits were observed in all the parameters in the DM group after the follow-up, except for the test of the meters walked in 6 min. CONCLUSIONS: The use of FES during daily walking is effective in patients with DA, reducing intermittent claudication and improving the quality of life of these patients.

A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment.

OBJECTIVE: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone. METHODS: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership.

Effect of Annurca Apple Polyphenols on Intermittent Claudication in Patients With Peripheral Artery Disease.

Peripheral arterial disease (PAD) is an atherosclerotic process involving both modifiable and nonmodifiable risk factors. Prospective cohort studies show that patients with PAD have a 6-fold greater risk of death from cardiovascular disease than those without PAD. Currently, there is no effective treatment for PAD. The study was a randomized, placebo-controlled trial, involving 180 patients, aged 35 to 75. The subjects were divided into 2 groups. One group underwent 24 weeks of nutraceutical treatment consisting in the administration of 4 capsules of Annurca apple polyphenolic extract (AMS)/day. The placebo group was administered with identically appearing capsules containing only maltodextrin. Primary outcome measures were: walking autonomy, ankle-brachial index, acceleration time. In the AMS group, at the end of the treatment period, walking autonomy was increased on average by 69% (p <0.05), while slighter effects were registered as regards ankle-brachial index (+25%; p <0.05) and acceleration time (-3.6%; p <0.05), when compared with baseline. Placebo group revealed no significant differences as regards variations of all outcomes measures (p >0.05). Our preliminary results may indicate AMS product as a promising natural and safe tool for treatment of symptoms related to PAD.

Antioxidant Effect of Far Infrared Radiation Produced by Bioceramics in Individuals with Intermittent Claudication: A Randomized, Controlled Pilot Study.

BACKGROUND: Biomedical research has recently incorporated bioceramics applications into new health care approaches. OBJECTIVE: This study evaluated the effect of far infrared-emitting bioceramics wraps in the treatment of intermittent claudication. METHODS: This is a randomized double-blind placebo-controlled pilot study. Thirty-five patients met the criteria and were randomized into either control (placebo wraps) or bioceramics group (far infrared emitting-ceramics wraps) and assessed over a 90-day period for the following outcomes: six-minute walk test (6MWT), ankle-brachial index (ABI), Flow-mediated arterial dilation (FMD), quality of life and claudication. Oxidative stress and inflammatory biomarkers were measured in plasma of patients. RESULTS: Intervention induced a decrease in oxidative stress, with significant lower levels of reactive substances to thiobarbituric acid (TBARS), as well as increase in superoxide dismutase and catalase enzyme activities. There was an increase in the environment subscale of the quality of life questionnaire. No statistically significant differences were found in the inflammatory cytokines, 6MWT, ABI and FMV evaluations. CONCLUSIONS: In Sum, FIR treatment improved oxidative stress profile and quality-of-life of patients with intermittent claudication. The study was registered into the ensaiosclinicos.gov.br (Registro Brasileiro de Ensaios Clínicos [ReBEC]) (RBR-7nr6sy register number).

Beet the Best?

RATIONALE: A primary goal of therapy for patients with peripheral artery disease (PAD) and intermittent claudication is increased ambulatory function. Supervised exercise rehabilitation was recently shown to confer superior walking benefits to pharmacological or surgical interventions. Increases in plasma inorganic nitrite, via oral nitrate, have been shown to increase exercise performance in both human and animal models, especially in hypoxic conditions. OBJECTIVE: To determine whether a 36-session exercise rehabilitation program while consuming oral inorganic nitrate (4.2 mmol concentrated beetroot juice) would produce superior benefits over exercise plus placebo in pain-free walking and markers of increased skeletal muscle perfusion in patients with PAD and intermittent claudication. METHODS AND RESULTS: This was a randomized, double-blind, per-protocol study design. After the 12-week protocol, claudication onset time on a maximal treadmill test increased by 59.2±57.3 s for the exercise plus placebo group (n=13) and by 180.3±46.6 s for the exercise plus beetroot juice group (n=11; P≤0.05). This produced a between treatment medium to large standardized effect size (Cohen d) of 0.62 (95% CI, -0.23 to +1.44). The data for 6-minute walk distance showed a similar pattern with increases of 24.6±12.1 and 53.3±19.6 m ( P≤0.05) in the exercise plus placebo and exercise plus beetroot juice groups, respectively. Measures of gastrocnemius perfusion, including ankle-brachial index, peak reactive hyperemic blood flow, and tissue deoxygenation characteristics, during exercise (assessed my near-infrared spectroscopy) all changed significantly for the exercise plus beetroot juice group with moderate-to-large effect sizes over exercise plus placebo changes. CONCLUSIONS: Although it is premature to speculate on overall clinical utility of a nitrate-based therapy for PAD, this early pilot study evidence is encouraging. Specifically, our data suggests that increasing plasma nitrite before exercise may allow PAD subjects to train with less pain, at higher workloads for longer durations at each training session, thereby maximizing the beneficial peripheral vascular and skeletal muscle adaptations. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01684930 and NCT01785524.

A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication.

BACKGROUND: Intermittent claudication is the most common symptom of peripheral arterial disease. Previous research has suggested that extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue. The objective of this feasibility pilot trial was to assess the safety, tolerability, and efficacy of ESWT as a novel treatment. METHODS: Patients with unilateral claudication were randomized to receive ESWT or sham treatment to the calf muscle three times per week for 3 weeks. Primary outcomes were pain-free walking distance (PFWD) and maximum walking distance (MWD). Secondary outcomes included safety and tolerability of ESWT treatment, ankle-brachial index before and after exercise, and quality of life assessed using generic (36-Item Short Form Health Survey, EuroQol-5 Dimension 3-Level) and disease-specific (Vascular Quality of Life) instruments. Participants were assessed at baseline and 4, 8, and 12 weeks after treatment. Feasibility outcomes included recruitment and attendance rates for treatment and follow-up. RESULTS: Thirty patients were recruited in total. Statistically significant (P < .05) improvements at all time points were observed in the active treatment group for both MWD and PFWD compared with the sham treatment group. PFWD improved by 276% in the active group and MWD improved by 167% in the active group at 12 weeks after treatment. There were no immediate or delayed treatment safety concerns or documented adverse effects of treatment with ESWT in this trial. CONCLUSIONS: ESWT is safe and well tolerated when it is applied to the calf and demonstrated significant improvements in walking distances. Current conservative management of intermittent claudication includes supervised exercise. The early results with ESWT as an alternative, noninvasive treatment option show great potential. The mechanism of action, durability of the clinical effect, and cost-effectiveness of ESWT for claudication require further investigation.

The efficacy of transcutaneous electrical nerve stimulation on the improvement of walking distance in patients with peripheral arterial disease with intermittent claudication: study protocol for a randomised controlled trial: the TENS-PAD study.

BACKGROUND: In patients with peripheral arterial disease (PAD), walking improvements are often limited by early pain onset due to vascular claudication. It would thus appear interesting to develop noninvasive therapeutic strategies, such as transcutaneous electrical nerve stimulation (TENS), to improve the participation of PAD patients in rehabilitation programmes, and thus improve their quality of life. Our team recently tested the efficacy of a single 45-min session of 10-Hz TENS prior to walking. TENS significantly delayed pain onset and increased the pain-free walking distance in patients with class-II PAD. We now seek to assess the efficacy of a chronic intervention that includes the daily use of TENS for 3 weeks (5 days a week) on walking distance in Leriche-Fontaine stage-II PAD patients. METHODS/DESIGN: This is a prospective, double-blind, multicentre, randomised, placebo-controlled trial. One hundred subjects with unilateral PAD (Leriche-Fontaine stage II) will be randomised into two groups (1:1). For the experimental group (TENS group): the treatment will consist of stimulation of the affected leg (at a biphasic frequency of 10 Hz, with a pulse width of 200 µs, maximal intensity below the motor threshold) for 45 min per day, in the morning before the exercise rehabilitation programme, for 3 weeks, 5 days per week. For the control group (SHAM group): the placebo stimulation will be delivered according to the same modalities as for the TENS group but with a voltage level automatically falling to zero after 10 s of stimulation. First outcome: walking distance without pain. SECONDARY OUTCOMES: transcutaneous oxygen pressure (TcPO2) measured during a Strandness exercise test, peak oxygen uptake (VO2 peak), endothelial function (EndoPAT®), Ankle-brachial Pressure Index, Body Mass Index, lipid profile (LDL-C, HDL-C, triglycerides), fasting glycaemia, HbA1c level, and the WELCH questionnaire. DISCUSSION: TENS-PAD is the first randomised controlled trial that uses transcutaneous electrical therapy as an adjuvant technique to improve vascular function in the treatment of PAD. If the results are confirmed, this technique could be incorporated into the routine care in cardiovascular rehabilitation centers and used in the long term by patients to improve their walking capacity. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02678403 . Registered on 9 February 2016. SPONSOR: Toulouse University Hospital.

The Effectiveness of Calf Muscle Electrostimulation on Vascular Perfusion and Walking Capacity in Patients Living With Type 2 Diabetes Mellitus and Peripheral Artery Disease.

The aim of the study was to explore calf muscle electrostimulation on arterial inflow and walking capacity in claudicants with peripheral artery disease and diabetes mellitus. A prospective, 1-group, pretest-posttest study design was used on 40 high-risk participants (n = 40) who exhibited bilateral limb ischemia (ankle brachial pressure index [ABPI] <0.90), diabetes mellitus, and calf muscle claudication. A program of calf muscle electrical stimulation with varying frequency (1-250 Hz) was prescribed for 1 hour per day for 12 weeks. Spectral waveforms analysis, ABPI, absolute claudication distance (ACD), and thermographic temperature patterns across 4 specified regions of interest (hallux, medial forefoot, lateral forefoot, heel) at rest and after exercise, were recorded at baseline and following intervention to evaluate for therapeutic outcomes. A significant improvement in ACD and ABPI was registered following the intervention ( P = .000 and P = .001, respectively). Resting foot temperatures increased significantly ( P = .000) while the postexercise temperature drops were halved across all regions at follow-up, with hallux ( P = .005) and lateral forefoot ( P = .038) reaching statistical significance. Spectral Doppler waveforms were comparable ( P = .304) between both serial assessments. Electrical stimulation of varying frequency for 1 hour per day for 12 consecutive weeks registered statistically significant improvement in outcome measures that assess arterial inflow and walking capacity in claudicants with diabetes mellitus. These results favor the use of electrostimulation as a therapeutic measure in this high-risk population.

Managing claudication in the community setting.

Advances made in medical management and treatment options in addressing lower extremity claudication and vascular disease have skyrocketed during the last decade. Given the recent advances in treatment options, there is often the perception within the medical community and general community that to get the most "cutting edge" treatment, one must go to an academic center or practitioner. The goal of this portion of the discussion is to explore the question of what differences in treatment options there are between a community practice and an academic practice within those members of the vascular surgery specialty. Are there really any differences in the types of treatments offered or availability of the different modalities, and what drives us as practitioners to one over the other?

Functional electrical stimulation improves quality of life by reducing intermittent claudication.

OBJECTIVE: To determine if Functional Electrical Stimulation (FES) would improve ischemic pain, walking distance, and quality of life of patients with intermittent claudication. DESIGN: Single blind, randomized block, two factorial design. PATIENTS: Patients diagnosed with Peripheral Artery Disease (PAD) and intermittent claudication (IC). Ankle Brachial Index ranged 0.4-0.9 on at least one leg. Patients were randomly assigned to experimental (FES+Walk, N=13) or control (WALK, N=14) groups. INTERVENTION: Experimental group patients received FES to the dorsiflexor and plantarflexor muscles while walking for 1h/day, six days/week for eight weeks. Control group patients received similar intervention without FES. A Follow-up period of both groups lasted eight weeks. OUTCOME MEASURES: Outcome measures were taken at baseline (T0), after intervention (T1), and after follow-up (T2). Primary measures included Perceived Pain Intensity (PPI), Six minute walk (6MW), and Peripheral Arterial Disease Quality of Life (PADQOL). Secondary measures included Intermittent Claudication Questionnaire (ICQ) and Timed Up and Go (TUG). RESULTS: Group by time interactions in PPI were significant (P<0.001) with differences of 27.9 points at T1 and 36.9 points at T2 favoring the FES+Walk group. Groups difference in Symptoms and Limitations in Physical Function of the PADQOL reached significance (T1=8.9, and T2=8.3 improvements; P=0.007). ICQ was significant (T1=9.3 and T2=13.1 improvements; P=0.003). Improvement in 6MW and TUG tests were similar between groups. CONCLUSIONS AND RELEVANCE: Walking with FES markedly reduced ischemic pain and enhanced QOL compared to just walking. FES while walking may offer an effective treatment option for the elderly with PAD and Intermittent Claudication. TRIAL REGISTRATION: NIH-NIA 1R21AG048001 https://projectreporter.nih.gov/project_info_description.cfm?aid=8748641&icde=30695377&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC. https://clinicaltrials.gov/ct2/show/NCT02384980?term=David+Embrey&rank=1.

Transcutaneous calf-muscle electro-stimulation: A prospective treatment for diabetic claudicants?

BACKGROUND: First-line therapy for claudicants with diabetes include supervised exercise programmes to improve walking distance. However, exercise comes with a number of barriers and may be contraindicated in certain conditions. The aim of this study was to evaluate whether calf-muscle electro-stimulation improves claudication distance. METHOD: A prospective, one-group, pretest-posttest study design was employed on 40 participants living with type 2 diabetes mellitus, peripheral artery disease (ankle-brachial pressure index < 0.90) and calf-muscle claudication. Calf-muscle electro-stimulation of varying frequencies (1-250 Hz) was applied on both ischaemic limbs (N = 80) for 1 h per day for 12 consecutive weeks. The absolute claudication distance was measured at baseline and following the intervention. RESULTS: The cohort (n = 40; 30 males; mean age = 71 years; mean ankle-brachial pressure index = 0.70) registered a mean baseline absolute claudication distance of 333.71 m (standard deviation = 208). Following 91.68 days (standard deviation = 6.23) of electrical stimulation, a significant mean increase of 137 m (standard deviation = 136) in the absolute claudication distance was registered (p = 0.000, Wilcoxon signed rank test). CONCLUSION: Electrical stimulation of varying low to high frequencies on ischaemic calf muscles significantly increased the maximal walking capacity in claudicants with type 2 diabetes. This therapeutic approach may be considered in patients with impaired exercise tolerance or as an adjunct treatment modality.

The role of kinesitherapy and electrotherapeutic procedures in non-operative management of patients with intermittent claudications.

PURPOSE: To examine the effects of physical therapy (kinesitherapy and electrotherapeutic procedures) on the course of peripheral arterial occlusive disease by monitoring the changes in values of claudication distance and ankle-brachial indexes. METHODS: Prospective randomized study included 47 patients with peripheral arterial occlusive disease manifested by intermittent claudications associated with ankle-brachial indexes values ranging from 0.5 to 0.9. Patients from the first group (25 pts) were treated with medicamentous therapy, walking exercises beyond the pain threshold, dynamic low-burden kinesi exercises and electrotherapeutic ageneses (interference therapy, diadynamic therapy, and electromagnetic field), while the second group of patients (22 pts) was treated with "conventional" non-operative treatment - medicamentous therapy and walking exercises. The values of newly established absolute claudication distance and ankle-brachial indexes were measured. FINDINGS: Significant increase of absolute claudication distance in both groups of patients was registered, independently of therapeutic protocol applied (p < 0.001), as well as the increase in the claudication distance interval in the physical therapy group. There was no significant increase in ankle-brachial indexes values in both groups of patients. CONCLUSION: Methods of physical therapy presented valuable supplement in non-operative treatment of peripheral arterial occlusive disease patients, improving their functional ability and thus postponing surgical treatment. However, further investigations including larger number of patients are needed.