scholarly journals Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial

2021 ◽  
Vol 4 (2) ◽  
pp. 29
Author(s):  
Fabio Manfredini ◽  
Nicola Lamberti ◽  
Luca Traina ◽  
Gladiol Zenunaj ◽  
Chiara Medini ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Controlled Trial ◽  
Ankle Brachial Index ◽  
Exercise Program ◽  
Walking Distance ◽  
Control Group ◽  
Peripheral Artery ◽  
Free Exercise ◽  
Home Based ◽  
Artery Disease

Exercise therapy in the intermediate stages of peripheral artery disease (PAD) represents an effective solution to improve mobility and quality of life (QoL). Home-based programs, although less effective than supervised programs, have been found to be successful when conducted at high intensity by walking near maximal pain. In this randomized trial, we aim to compare a low-intensity, pain-free structured home-based exercise (SHB) program to an active control group that will be advised to walk according to guidelines. Sixty PAD patients aged > 60 years with claudication will be randomized with a 1:1 ratio to SHB or Control. Patients in the training group will be prescribed an interval walking program at controlled speed to be performed at home; the speed will be increased weekly. At baseline and after 6 months, the following outcomes will be collected: pain-free walking distance and 6-min walking distance (primary outcome), ankle-brachial index, QoL by the VascuQoL-6 questionnaire, foot temperature by thermal camera, 5-time sit-to-stand test, and long-term clinical outcomes including revascularization rate and mortality. The home-based pain-free exercise program may represent a sustainable and cost effective option for patients and health services. The trial has been approved by the CE-AVEC Ethics Committee (898/20). Registration details: Clinicaltrials.gov NCT04751890 [Registered: 12 February 2021].

scholarly journals A randomized, placebo-controlled trial of canakinumab in patients with peripheral artery disease

2019 ◽  
Vol 24 (5) ◽  
pp. 414-421
Author(s):  
Kerry S Russell ◽  
Denise P Yates ◽  
Christopher M Kramer ◽  
Andrea Feller ◽  
Ping Mahling ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Controlled Trial ◽  
Ankle Brachial Index ◽  
Walking Distance ◽  
Plaque Burden ◽  
Black Blood ◽  
Plaque Progression ◽  
Peripheral Artery ◽  
Wall Area ◽  
Artery Disease

Extensive atherosclerotic plaque burden in the lower extremities often leads to symptomatic peripheral artery disease (PAD) including impaired walking performance and claudication. Interleukin-1β (IL-1β) may play an important pro-inflammatory role in the pathogenesis of this disease. Interruption of IL-1β signaling was hypothesized to decrease plaque progression in the leg macrovasculature and improve the mobility of patients with PAD with intermittent claudication. Thirty-eight patients (mean age 65 years; 71% male) with symptomatic PAD (confirmed by ankle–brachial index) were randomized 1:1 to receive canakinumab (150 mg subcutaneously) or placebo monthly for up to 12 months. The mean vessel wall area (by 3.0 T black-blood magnetic resonance imaging (MRI)) of the superficial femoral artery (SFA) was used to measure plaque volume. Mobility was assessed using the 6-minute walk test. Canakinumab was safe and well tolerated. Markers of systemic inflammation (interleukin-6 and high-sensitivity C-reactive protein) fell as early as 1 month after treatment. MRI (32 patients at 3 months; 21 patients at 12 months) showed no evidence of plaque progression in the SFA in either placebo-treated or canakinumab-treated patients. Although an exploratory endpoint, placebo-adjusted maximum and pain-free walking distance (58 m) improved as early as 3 months after treatment with canakinumab when compared with placebo. Although canakinumab did not alter plaque progression in the SFA, there is an early signal that it may improve maximum and pain-free walking distance in patients with symptomatic PAD. Larger studies aimed at this endpoint will be required to definitively demonstrate this. ClinicalTrials.gov Identifier: NCT01731990

scholarly journals Don’t stop walking: an in-home rehabilitation program for peripheral artery disease patients during the COVID-19 pandemic.

2020 ◽  
Author(s):  
Nicola Lamberti ◽  
Sofia Straudi ◽  
Roberto Manfredini ◽  
Alfredo De Giorgi ◽  
Vincenzo Gasbarro ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Ankle Brachial Index ◽  
Exercise Program ◽  
Rehabilitation Program ◽  
Walking Distance ◽  
Walking Ability ◽  
Peripheral Artery ◽  
Walking Program ◽  
External Conditions ◽  
Artery Disease

Abstract Aims: We studied the outcomes of peripheral artery disease (PAD) patients enrolled in a structured in-home walking program before the lockdown due to the SARS-CoV-2 epidemic emergency, to determine whether this intervention ensured the maintenance of mobility in the case of strict movement restrictions.Methods: We considered 83 patients (age 72±11, males n=65) enrolled in a rehabilitation program based on two daily 8-minute sessions of slow intermittent in-home walking at a prescribed cadence with circa-monthly hospital visits. During the lockdown period, the program was updated by phone. The 6-minute (6MWD) and pain-free walking distance (PFWD) were measured pre- and postlockdown. Body weight (BW), blood pressure (BP), and the ankle-brachial index (ABI) were also determined.Results: Sixty-six patients were measured 117±23 days after their previous visit. A safe, pain-free execution the prescribed sessions, with a median distance covered of 74 km, was reported. Overall, the 6MWD was stable, while PFWD improved (p<0.001). Decreased BW with stable BP and ABI values were also recorded. When considering the outcome values according to the time of enrollment before the lockdown, new-entry subjects (≤3 months; n=35) obtained significant improvements, while those previously enrolled (>3 months; n= 31) were stable.Conclusion: In PAD patients, a structured exercise program easily performed in a home corridor and guided with phone assistance was adhered to by patients and showed effectiveness in maintaining mobility and risk factor control during the COVID-19 pandemic. Safe structured exercise may involve frail subjects regardless of walking ability, type of home and external conditions.

scholarly journals Restless Leg Syndrome in Peripheral Artery Disease: Prevalence among Patients with Claudication and Benefits from Low-Intensity Exercise

2019 ◽  
Vol 8 (9) ◽  
pp. 1403
Author(s):  
Lamberti ◽  
López-Soto ◽  
Rodríguez-Borrego ◽  
Straudi ◽  
Basaglia ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Near Infrared ◽  
Ankle Brachial Index ◽  
Exercise Program ◽  
Restless Leg Syndrome ◽  
Peripheral Artery ◽  
Low Intensity ◽  
Home Based ◽  
Artery Disease ◽  
Low Intensity Exercise

Restless leg syndrome (RLS) disrupts sleep, affecting the quality of life of patients with various chronic diseases. We assessed the prevalence of RLS in peripheral artery disease (PAD) patients and the effects of a pain-free exercise program. A total of 286 patients with claudication were enrolled in a home-based low-intensity exercise program prescribed at the hospital. RLS was determined through standardized questions. Hemodynamics, degree of calf deoxygenation, and mobility were assessed using the ankle-brachial-index, a treadmill test assisted by near-infrared spectroscopy and the 6-min walk test, respectively. During hospital visits, persistence of RLS, adherence to exercise, hemodynamics, and mobility were assessed. At the enrollment, 101 patients (35%) presented RLS, with higher prevalence among females (p = 0.032). Compared to RLS-free patients, they showed similar hemodynamics but more severe calf deoxygenation (p < 0.001) and lower mobility (p = 0.040). Eighty-seven RLS patients (83%) reported the disappearance of symptoms after 39 (36−70) days of exercise. This subgroup, compared to nonresponders, showed higher adherence (p < 0.001), hemodynamic (p = 0.041), and mobility improvements (p = 0.003). RLS symptoms were frequent in PAD but were reduced by a pain-free walking exercise aimed at inducing peripheral aerobic adaptations. The concomitant recovery of sleep and mobility may represent a synergistic action against the cardiovascular risk in PAD.

Abstract 11: Effects of Canakinumab in Patients With Peripheral Artery Disease

2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Kerry S Russell ◽  
Denise Yates ◽  
Andrea Feller ◽  
Tianke Wang ◽  
Ping Chen ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Vascular Function ◽  
Cardiovascular Events ◽  
Ankle Brachial Index ◽  
Unmet Need ◽  
Walking Distance ◽  
Plaque Progression ◽  
Peripheral Artery ◽  
Plaque Volume ◽  
Artery Disease

Background: Peripheral artery disease (PAD) affects 8.5 million people in the US. PAD patients are at high risk for cardiovascular events, and their quality of life is often significantly impaired by decreased mobility. Interleukin-1β (IL-1β) may play an important role in this disease by promoting inflammatory responses that drive atherosclerotic plaque progression and impair vascular function. We sought to test whether interruption of IL-1β signaling would improve patient mobility and decrease plaque progression in the lower extremities. Methods: 38 patients (mean age 65; 71% male) with symptomatic PAD (confirmed by ankle-brachial index) were randomized 1:1 to receive Canakinumab (150 mg subcutaneously) or placebo monthly for up to 12 months. Plaque volume in the superficial femoral artery (SFA) was assessed serially using 3.0T MRI. Mobility was assessed serially using the 6-minute walk test (maximum and pain-free walking distance). Results: Canakinumab was safe and well-tolerated. 12 patients discontinued (8 placebo, 4 Canakinumab). MRI data (from 31 patients at 3 months; 21 patients at 12 months) showed no evidence of plaque progression in the SFA at either time point in placebo-treated patients; nor was there a change in plaque volume in the Canakinumab-treated group. There was a serial and significant improvement in placebo-adjusted maximum and pain-free walking distance observed as early as 3 months after treatment with Canakinumab (58-meter improvement over placebo in pain-free distance at 3 months, P=0.01). Two placebo-treated patients required peripheral vascular interventions due to progression of disease; however, no Canakinumab-treated patients required revascularization during the study. Canakinumab decreased markers of systemic inflammation (IL-6 and hsCRP). Conclusions: Treatment with Canakinumab may improve maximum and pain-free walk distance in patients with symptomatic PAD. In conjunction with results soon to be reported for the CANTOS trial of Canakinumab for secondary prevention of cardiovascular events, additional studies may provide support that inhibition of IL-1β signaling can improve symptoms and function in this patient population with high unmet need.

scholarly journals Minimal clinically important differences in treadmill, 6-minute walk, and patient-based outcomes following supervised and home-based exercise in peripheral artery disease

2018 ◽  
Vol 23 (4) ◽  
pp. 349-357 ◽  
Author(s):  
Andrew W Gardner ◽  
Polly S Montgomery ◽  
Ming Wang
Keyword(s):  
Peripheral Artery Disease ◽  
Exercise Program ◽  
Exercise Group ◽  
Treadmill Test ◽  
Peripheral Artery ◽  
Exercise Programs ◽  
Supervised Exercise ◽  
Home Based ◽  
Artery Disease ◽  
Minute Walk

We estimated minimal clinically important differences (MCIDs) for small, moderate, and large changes in measures obtained from a standardized treadmill test, a 6-minute walk test, and patient-based outcomes following supervised and home-based exercise programs in symptomatic patients with peripheral artery disease (PAD). Patients were randomized to either 12 weeks of a supervised exercise program ( n=60), a home-based exercise program ( n=60), or an attention-control group ( n=60). Using the distribution-based method to determine MCIDs, the MCIDs for small, moderate, and large changes in peak walking time (PWT) in the supervised exercise group were 38, 95, and 152 seconds, respectively, and the changes in claudication onset time (COT) were 35, 87, and 138 seconds. Similar MCID scores were noted for the home-based exercise group. An anchor-based method to determine MCIDs yielded similar patterns of small, moderate, and large change scores in PWT and COT, but values were 1–2 minutes longer than the distribution approach. In conclusion, 3 months of supervised and home-based exercise programs for symptomatic patients with PAD results in distribution-based MCID small, moderate, and large changes ranging from 0.5 and 2.5 minutes for PWT and COT. An anchor-based approach yields higher MCID values, ranging from a minimum of 73 seconds for COT to a maximum of 4 minutes for PWT. The clinical implication is that a goal for eliciting MCIDs in symptomatic PAD patients through a walking exercise intervention is to increase PWT and COT by up to 4 minutes, which corresponds to two work stages during the standardized progressive treadmill test.

scholarly journals Rehabilitative Exercise Reduced the Impact of Peripheral Artery Disease on Vascular Outcomes in Elderly Patients with Claudication: A Three-Year Single Center Retrospective Study

2019 ◽  
Vol 8 (2) ◽  
pp. 210 ◽  
Author(s):  
Fabio Manfredini ◽  
Nicola Lamberti ◽  
Franco Guerzoni ◽  
Nicola Napoli ◽  
Vincenzo Gasbarro ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Peripheral Artery Disease ◽  
Ankle Brachial Index ◽  
Rehabilitation Program ◽  
Peripheral Artery ◽  
Rehabilitation Outcomes ◽  
Home Based ◽  
Severe Group ◽  
Artery Disease ◽  
The Impact

The study retrospectively evaluated the association between rehabilitative outcomes and risk of peripheral revascularizations in elderly peripheral artery disease (PAD) patients with claudication. Eight-hundred thirty-five patients were enrolled. Ankle-brachial index (ABI) and maximal walking speed (Smax) were measured at baseline and at discharge from a structured home-based rehabilitation program. For the analysis, patients were divided according to a baseline ABI value (severe: ≤0.5; moderate: ≥0.5) and according to hemodynamic or functional rehabilitative response (responder: ABI ≥0.10 and/or Smax >0.5 km/h). Three-year outcomes were collected from the regional registry. According to the inclusion criteria (age 60–80, ABI <0.80; program completion) 457 patients, 146 severe and 311 moderate, were studied. The whole population showed significant functional and hemodynamic improvements at discharge, with 56 revascularizations and 69 deaths at follow-up. Compared to the moderate group, the severe group showed a higher rate of revascularizations (17% vs. 10%, p < 0.001) and deaths (29% and 8%, respectively; p < 0.001). However, patients with severe PAD who were ABI responders after rehabilitation showed less revascularizations than non-responders (13% vs. 21%; hazard ratio (HR): 0.52) and were not different from patients with moderate disease (9%). Superimposable rates were observed for Smax responders (13% vs. 21%; HR: 0.55; moderate 10%). In conclusion, elderly patients with severe PAD empowered by better rehabilitation outcomes showed lower rates of peripheral revascularizations and deaths that were comparable to patients with moderate PAD.

Effect of Sex on Vascular Adaptations to Isometric Handgrip Training in Elderly Patients with Peripheral Artery Disease: A Randomized Controlled Trial

2021 ◽  
pp. 1-4
Author(s):  
Paulo L. Oliveira ◽  
Marilia A. Correia ◽  
Nelson Wolosker ◽  
Lauro C. Vianna ◽  
Raphael M. Ritti-Dias ◽  
...  
Keyword(s):  
Older Adults ◽  
Peripheral Artery Disease ◽  
Controlled Trial ◽  
Maximum Voluntary Contraction ◽  
Control Group ◽  
Flow Mediated Dilation ◽  
Peripheral Artery ◽  
Isometric Handgrip ◽  
Artery Disease ◽  
Isometric Handgrip Training

<b><i>Background:</i></b> Isometric handgrip training (IHT) promotes vascular adaptations in different populations. <b><i>Aims:</i></b> We assessed the sex differences in vascular adaptations of IHT in a sample of older adults with symptomatic peripheral artery disease (PAD). <b><i>Methods:</i></b> Fifty-three older patients with symptomatic PAD (6 women and 13 men in IHT and 13 women and 21 men in the control group) participated in this study. The IHT group performed 3 sessions per week, for 8 weeks, consisting of 4 sets of isometric contractions for 2 min at 30% of maximum voluntary contraction and a 4-min interval between sets. The control group received a compression ball in order to minimize the placebo effects, representing sham training. Blood flow and brachial flow-mediated dilation were analyzed at before and after 8 weeks of intervention. We compared the responses (Δ = post-pre values) of each group (women control, women IHT, men control, and men IHT) with a Kruskal-Wallis test. <b><i>Results:</i></b> There were no differences in all groups after 8 weeks of IHT in Δ brachial diameter (<i>p</i> = 0.850), Δ flow-mediated dilation (<i>p</i> = 0.241), Δ time to peak diameter (<i>p</i> = 0.528), and Δ FMD/AUC (<i>p</i> = 0.397). <b><i>Conclusions:</i></b> There are no effects of sex on vascular adaptation after 8 weeks of IHT in older adults with symptomatic PAD.

Effectiveness of a Home-Based Exercise Program on Walking Ability in Patients with Peripheral Artery Disease—The HONOR Trial

2020 ◽  
Author(s):  
Mary McDermott ◽  
Bonnie Spring ◽  
Jeffrey Berger ◽  
Diane Treat-Jacobson ◽  
Michael Conte ◽  
...  
Keyword(s):  
Peripheral Artery Disease ◽  
Exercise Program ◽  
Walking Ability ◽  
Peripheral Artery ◽  
Home Based ◽  
Artery Disease

scholarly journals Biomarkers of Muscle Metabolism in Peripheral Artery Disease: A Dynamic NIRS-Assisted Study to Detect Adaptations Following Revascularization and Exercise Training

Diagnostics ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. 312 ◽  
Author(s):  
Fabio Manfredini ◽  
Nicola Lamberti ◽  
Valentina Ficarra ◽  
Elpiniki Tsolaki ◽  
Sofia Straudi ◽  
...  
Keyword(s):  
Exercise Training ◽  
Peripheral Artery Disease ◽  
Near Infrared ◽  
Ankle Brachial Index ◽  
Muscle Metabolism ◽  
The Novel ◽  
Peripheral Artery ◽  
Home Based ◽  
Artery Disease

We assessed whether muscle metabolism biomarkers (MMb) identified by near-infrared spectroscopy (NIRS) are valid for determining adaptations following revascularization or exercise training in peripheral artery disease (PAD). Eighteen patients (males n = 13; 69 ± 7 years) were randomized to receive revascularization (Rev = 6) or pain-free home-based exercise (Ex = 12). MMb were safely collected via a NIRS-assisted treadmill test as area-under-curve for the spectra of oxygenated (-oxy), deoxygenated (-deoxy), differential (-diff) and total (-tot) hemoglobin traces. MMb, ankle–brachial index (ABI), pain-free (PFWD) and 6-min (6MWD) walking distances were assessed at baseline and after four months. MMb were correlated at baseline with ABI (MMb-oxy r = 0.46) and 6MWD (MMb-tot r = 0.51). After treatments, MMb-oxy showed an expected increase, which was more relevant for Rev group than the Ex (56% vs. 20%), with trends towards normalization for the other MMb. These changes were significantly correlated with variations in ABI (MMb-oxy r = 0.71; p = 0.002) and 6MWD (MMb-tot r = 0.58; p = 0.003). The MMb-diff in Rev group and MMb-deoxy in Ex group at baseline predicted clinical outcomes being correlated with PFWD improvements after 4-month (r = −0.94; p = 0.005 and r = −0.57; p = 0.05, respectively). A noninvasive NIRS-based test, feasible in a clinical setting, identified muscle metabolism biomarkers in PAD. The novel MMb were associated with validated outcome measures, selectively modified after different interventions and able to predict long-term functional improvements after surgery or exercise training.

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