Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study).

INTRODUCTION: Supervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and frequency. However, no guidance is offered regarding exercise training intensity. This study aims to compare the effects of 12-week-long supervised walking exercise training (high-intensity interval training (HIIT) vs moderate-intensity exercise (MOD)) in patients with chronic symptomatic PAD. METHODS AND ANALYSIS: This study is a monocentric, interventional, non-blinded randomised controlled trial. 60 patients (30 in each group) will be randomly allocated (by using the random permuted blocks) to 12 weeks (three times a week) of HIIT or MOD. For HIIT, exercise sessions will consist of alternating brief high-intensity (≥85% of the peak heart rate (HRpeak)) periods (≤60 s) of work with periods of passive rest. Patients will be asked to complete 1 and then 2 sets of 5-7 (progressing to 10-15×60 s) walking intervals. For the MOD group, exercise training sessions will consist of an alternation of periods of work performed at moderate intensity (≤76% HRpeak) and periods of passive rest. Interventions will be matched by training load. The primary outcome will be the maximal walking distance. Secondary outcomes will include functional performance, functional capacity, heath-related quality of life, self-perceived walking abilities, physical activity and haemodynamic parameters. ETHICS AND DISSEMINATION: The Angiof-HIIT Study was approved by the Human Research Ethics Committee of the Canton de Vaud (study number: 2022-01752). Written consent is mandatory prior to enrolment and randomisation. The results will be disseminated via national and international scientific meetings, scientific peer-reviewed journals and social media. TRIAL REGISTRATION NUMBER: NCT05612945.

Exercise therapy for chronic symptomatic peripheral artery disease.

All guidelines worldwide strongly recommend exercise as a pillar of the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended for clinicians to promote and assist for the set-up of comprehensive exercise programmes to best advice in patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are narratively described based on the current best evidence. The document ends by highlighting disparities in access to supervised exercise programmes across Europe and the series of gaps for evidence requiring further research.

Exercise therapy for chronic symptomatic peripheral artery disease.

All guidelines worldwide strongly recommend exercise as a pillar in the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended to promote and assist the set up of comprehensive exercise programmes and best advice for patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are described based on the current best evidence. The document ends by highlighting supervised exercise programme access disparities across Europe and the evidence gaps requiring further research.

Exercise Therapy for Chronic Symptomatic Peripheral Artery Disease: A Clinical Consensus Document of the European Society of Cardiology Working Group on Aorta and Peripheral Vascular Diseases in Collaboration With the European Society of Vascular Medicine and the European Society for Vascular Surgery.

All guidelines worldwide strongly recommend exercise as a pillar in the management of patients affected by lower extremity peripheral artery disease (PAD). Exercise therapy in this setting presents different modalities, and a structured programme provides optimal results. This clinical consensus paper is intended to promote and assist the set up of comprehensive exercise programmes and best advice for patients with symptomatic chronic PAD. Different exercise training protocols specific for patients with PAD are presented. Data on patient assessment and outcome measures are described based on the current best evidence. The document ends by highlighting supervised exercise programme access disparities across Europe and the evidence gaps requiring further research.

Supervised Exercise Training May Improve Postural Control in Patients with Symptomatic Lower Extremity Peripheral Artery Disease.

Patients with symptomatic peripheral artery disease (PAD) have been shown to present balance disorders and a history of falling, which are associated with functional and daily life impairments. Although postural control improvement is an important outcome, the benefits of supervised exercise training (SET) on postural control have been seldom investigated in these patients. This article investigates the effects of SET on traditional measures of postural control and on stabilogram-diffusion analysis (SDA) parameters in patients with symptomatic PAD. Patients with symptomatic chronic lower limb claudication were investigated. All subjects who completed the 3-month multimodal SET program and postural control assessment before and after SET were included. Center of pressure trajectory analysis and SDA parameters were investigated using a posturographic platform. Patients were instructed to stand on the platform and maintain balance to their best ability. Treadmill pain-free (PFWD) and maximal (MWD) walking distances were also assessed prior and following SET. Forty-four patients with PAD (65.2 ± 9.8 years, 34% women) were investigated. All postural control parameters were unchanged following SET, except the length of center of pressure displacement as a function of the surface of center of pressure trajectory (LFS), which was significantly increased (before SET: 1.4 ± 0.4; after SET: 1.5 ± 0.5; p = 0.042). PFWD (before SET: 103.5 ± 77.9 m; after SET: 176.8 ± 130.6 m; p ≤ 0.001) and MWD (before SET: 383.6 ± 272.0 m; after SET: 686.4 ± 509.0 m; p ≤ 0.001) significantly improved following SET. The increased LFS suggests a better postural control accuracy following SET in patients with symptomatic PAD.

Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial.

Objective: To test the effect of a complex, interdisciplinary, lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus during pregnancy and in the post partum. Design: Single centred, single blinded, randomised, controlled trial (the MySweetheart trial). Setting: Lausanne University Hospital, Switzerland, from 2 September 2016 to 25 October 2021. Participants: 211 women aged at least 18 years with a diagnosis of gestational diabetes mellitus at 24-32 gestational weeks were randomly assigned (1:1) to the intervention (n=105) or to usual care (n=106). Interventions: In addition to a comparator based on active guidelines for prepartum and postpartum usual care, the intervention consisted of four individual lifestyle visits during pregnancy and four interdisciplinary visits in the postpartum group, a peer support group workshop in pregnancy and post partum, and a bimonthly lifestyle coach support through telemedicine. The intervention focused on tailored behavioural and psychosocial strategies to improve diet, physical activity, mental health, social support, and adherence to gestational weight gain during pregnancy and weight retention recommendations. Main outcome measures: Primary outcomes were between-group differences in the decrease in maternal weight and depression symptom scores between baseline and one year post partum. Secondary outcomes included changes in total and central body fat, anxiety, wellbeing, glycaemic parameters (homeostatic model assessment for insulin resistance (known as HOMA-IR) and Matsuda indices), aerobic fitness (maximal oxygen uptake), gestational weight gain, and weight retention. Assessors were blinded to primary and secondary outcomes. Results: 84 (80%) of 105 women in the intervention and 95 (90%) of 106 in the usual care completed the study. There was not enough evidence of a difference in the decrease in weight (mean difference -0.38 kg (95% confidence interval -2.08 to 1.30)) or depression scores (-0.67 (-1.84 to 0.49)). The intervention led to an increase in fat-free mass (0.02 kg (0.01 to 0.03)). The intervention also decreased gestational weight gain since the first gestational diabetes mellitus visit (-1.20 kg (-2.14 to -0.26)) and weekly weight gain throughout the entire pregnancy (-0.14 kg (-0.25 to -0.03)), and led to a higher proportion of women without weight retention at one year post partum (34.1% (28/82) v 20.8% (20/96), P=0.034). Conclusions: Compared with active usual care based on guidelines, there was not enough evidence to conclude that the intervention led to decrease in weight or depression symptoms. However, the intervention decreased gestational weight gain and increased the proportion of women without weight retention. Trial registration: Clinicaltrials.gov NCT02890693.

The link between impaired oxygen supply and cognitive decline in peripheral artery disease.

Although peripheral artery disease (PAD) primarily affects large arteries outside the brain, PAD is also associated with elevated cerebral vulnerabilities, including greater risks for brain injury (such as stroke), cognitive decline and dementia. In the present review, we aim to evaluate recent literature and extract information on potential mechanisms linking PAD and consequences on the brain. Furthermore, we suggest novel therapeutic avenues to mitigate cognitive decline and reduce risk of brain injury in patients with PAD. Various interventions, notably exercise, directly or indirectly improve systemic blood flow and oxygen supply and are effective strategies in patients with PAD or cognitive decline. Moreover, triggering protective cellular and systemic mechanisms by modulating inspired oxygen concentrations are emerging as potential novel treatment strategies. While several genetic and pharmacological approaches to modulate adaptations to hypoxia showed promising results in preclinical models of PAD, no clear benefits have yet been clinically demonstrated. We argue that genetic/pharmacological regulation of the involved adaptive systems remains challenging but that therapeutic variation of inspired oxygen levels (e.g., hypoxia conditioning) are promising future interventions to mitigate associated cognitive decline in patients with PAD.

Time-course evolution of functional performance during a 3-month supervised exercise training program in patients with symptomatic peripheral artery disease.

INTRODUCTION: Functional performance is impaired in patients with peripheral artery disease (PAD). The effects of a supervised exercise training (SET) program on functional performance have yet to be clearly determined. The aim was to investigate the time-course evolution of functional performance during a 3-month SET program. METHODS: Patients with chronic symptomatic PAD participating in a 3-month SET program were investigated. Six-minute walking distance (6MWD), the stair climbing test (SCT), and the Short Physical Performance Battery (SPPB) were assessed before SET, after the first and second months of SET, and following the SET program. The ankle- and toe-brachial indices were measured before and after the SET program. RESULTS: Ninety patients with PAD (age 65.4 ± 10.2 years) were analyzed. The 6MWD significantly improved after the first (+7%, p ⩽ 0.001) and second months (+13%, p ⩽ 0.001) and following SET (+14%, p ⩽ 0.001) compared to before the SET program. The 6MWD significantly improved after the 2nd month (+6%, p ⩽ 0.001) and following SET (+7%, p ⩽ 0.001) compared to after the first month of the SET program. The SPPB score and SCT performance significantly improved after the first (SPPB score: +9%, p ⩽ 0.001; SCT: +17%, p ⩽ 0.001) and second months (SPPB score: +11%, p ⩽ 0.001; SCT: +24%, p ⩽ 0.001) and following SET (SPPB score: +12%, p ⩽ 0.001; SCT: +25%, p ⩽ 0.001) compared to before the SET program. No significant differences were observed following SET compared to the second month of the SET program. Vascular parameters did not change significantly. CONCLUSIONS: A 3-month SET program improves several components of functional performance, and adaptations mainly occur during the 1st and 2nd months of the SET program.

Effect of the MySweetheart randomized controlled trial on birth, anthropometric and psychobehavioral outcomes in offspring of women with GDM.

Introduction: Gestational diabetes mellitus (GDM) may negatively affect offspring outcomes. A lifestyle intervention may therefore not only improve maternal, but also offspring outcomes. The effects of lifestyle interventions on birth, anthropometric, and psychobehavioral outcomes in offspring of women with GDM need further evidence. Design: The MySweetheart trial is a monocentric single-blind randomized controlled trial in 211 women with GDM. It tested the effect of a pre- and postpartum multidimensional interdisciplinary lifestyle and psychosocial intervention focusing on both the mothers and their infants and its effects on maternal (primary outcomes) and offspring (secondary outcomes) metabolic and psychobehavioral outcomes compared with guidelines-based usual-care. This paper focuses on offspring's birth, anthropometric, and maternal report of psychobehavioral outcomes at singular timepoints. Methods: Women with GDM aged ≥18 years, between 24-32 weeks of gestation, speaking French or English were included and randomly allocated to either the intervention or to an active guidelines-based usual-care group using a 1:1 allocation ratio. The intervention lasted from pregnancy until 1 year postpartum and focused on improving diet, physical activity, and mental health in the mother. For the offspring it focused on supporting breastfeeding, delaying the timing of introduction of solid foods, reducing the consumption of sweetened beverages, increasing physical activity of the family, and improving parental responsiveness to infant distress, hunger, satiety and sleeping cues, and difficult behavior. Results: Adverse birth and neonatal outcomes rarely occurred overall. There were no differences between groups in offspring birth, neonatal, anthropometric, or psychobehavioral outcomes up to one year. After adjustments for maternal age and the offspring's sex and age, there was a borderline significant between-group difference in birth length (ß:-0.64, CI:-1.27; -0.01, p: 0.05), i.e., offspring of mothers in the intervention group were born 0.64 cm shorter compared to those in the usual-care group. Conclusion: This is the first pre- and postpartum multidimensional interdisciplinary lifestyle and psychosocial intervention in GDM focusing on both the mother and the offspring. It did not lead to a significant improvement in most birth, anthropometric, and psychobehavioral outcomes in offspring of women with GDM. ClinicalTrials.gov Identifier: NCT02890693.

Sit to Stand Muscle Power Is Related to Functional Performance at Baseline and After Supervised Exercise Training in Patients with Lower Extremity Peripheral Artery Disease.

OBJECTIVE: Patients with peripheral artery disease (PAD) have decreased muscle power, contributing to functional limitations. The sit to stand (STS) is a validated test to assess muscle power in older individuals; however, it has never been investigated in patients with PAD. The relationship between STS muscle power, and common disease related outcomes was evaluated at baseline and following supervised exercise training (SET) in patients with PAD. METHODS: This observational study investigated patients with Fontaine stage II. Before and after SET, maximum treadmill walking distance (MWD), functional performance tests (six minute walk, STS, stair climbing, habitual gait speed), and quality of life (Short Form 36 questionnaire) were assessed. Relative (W/kg) STS muscle power was calculated using a validated equation. Multiple regressions models were used. RESULTS: Ninety-five patients with PAD were included (63.1 ± 12.1 years, 67% male). Relative STS muscle power before: 2.7 W/kg, 95% confidence interval [CI] 2.5 - 2.9; after: 3.3, 95% CI 3.1 - 3.6, MWD before: 367.0 m, 95% CI 302.4 - 431.5; after: 598.4, 95% CI 515.6 - 681.3, six minute walking distance before: 418.3 metres; 95% CI 399.4 - 437.2; after: 468.8; 95% CI 452.7-484.9, stair climbing performance before: 6.8 seconds 95% CI 6.2 - 7.4); after: 5.3; 95% CI 4.9 - 5.7, habitual gait speed before: 1.10 m/s, 95% CI 1.05 - 1.14; after: 1.18, 95% CI 1.14 - 1.22 increased significantly following SET (p < .001). Similarly, physical before: 31.4, 95% CI 29.4 - 33.3; after: 35.8, 95% CI 33.9 - 37.7 and mental before: 39.5, 95% CI 37.0 - 42.0; after: 43.1, 95% CI 40.9 - 45.4 component summaries of the SF-36 also increased significantly (p < .001). Greater relative STS muscle power at baseline was significantly related to greater baseline treadmill (ß < .380; p < .002) and functional (ß < .597; p < .001) performance, and quality of life (ß < .291; p < .050). Larger increases in relative STS muscle power following SET were associated with greater improvements in functional performance (ß < .419; p < .009). CONCLUSION: The STS test is a valid clinical tool to monitor overall functional status in patients with symptomatic PAD.

[Physical therapy in vascular diseases]. / L'exercice physique dans les maladies vasculaires.

Regular physical exercise reduces the risk of developing cardiovascular diseases. Along with cardiovascular risk factors management, physical exercise is considered as one of the main treatment components in people with cardiovascular diseases. The therapeutic role of physical exercise in patients with peripheral artery disease has been highlighted for decades. However, the role of physical exercise in the management of patients with venous, lymphatic, or rare vascular diseases remains poorly investigated. This article discuss the potential benefits of physical exercise in the therapeutic care of patients with vascular diseases.

Il est bien connu que l'exercice physique régulier diminue le risque de contracter une maladie cardiovasculaire. Chez les personnes avec une maladie cardiovasculaire, l'exercice physique est considéré, avec le contrôle strict des facteurs de risque cardiovasculaire, comme un élément capital de la prise en charge. Depuis des décennies, on met en évidence le rôle de l'exercice physique dans l'amélioration de la mobilité et de la qualité de vie des patient-e-s avec une maladie artérielle périphérique. Cependant, le rôle de l'exercice physique dans la prise en charge des patient-e-s avec des maladies veineuses, lymphatiques ou des maladies vasculaires rares demeure peu investigué. Cet article met en évidence les potentiels bénéfices de l'exercice physique dans la prise en charge des patient-e-s avec des maladies vasculaires.

Supervised exercise training in patients with lower extremity peripheral artery disease.

The optimal first line management of patients with symptomatic chronic lower extremity peripheral artery disease (PAD) includes secondary prevention of cardiovascular risk factors, pharmacological treatment, and supervised exercise therapy (SET). SET programs have shown to be effective in improving walking performance, functional performance, and quality of life. However, despite a large body of evidence, and despite national and international guidelines recommending SET as first line therapy, SET remains largely underused in patients with chronic PAD. This position paper aims to describe how SET is perceived, its accessibility and structure through Europe. An anonymous web-based survey was used. It comprised 21 questions developed in conjunction with an angiologist and a clinical exercise physiologist specialist in vascular rehabilitation. We had 131 responders from 17 countries. For patients with PAD, SET programs exist only in 59% of European countries. SET reimbursement is available in 41% of countries. SET programs showed to be heterogeneous across countries. Thirty-four percent of the SET programs are PAD-dedicated, while 23% are part of a cardiac rehabilitation program. In addition, among existing SET programs, 65% are dedicated to symptomatic patients with PAD only, 9% to both asymptomatic and symptomatic, 8% to post-revascularized patients only, and 1% to asymptomatic patients with PAD only. Finally, 17% reported not knowing which patients are eligible for enrolment in a SET program. Duration, frequency, and modality of SET also varied from country to country. Overall, these data indicate that a large variability of SET availability and characteristics exists across Europe. Therefore, there is an urgent need to provide detailed guidance to deliver optimal exercise therapeutic care in patients with PAD.

Intensity-dependent effects of exercise therapy on walking performance and aerobic fitness in symptomatic patients with lower-extremity peripheral artery disease: A systematic review and meta-analysis.

We investigated how nonpain-based exercise therapy intensity (light-to-moderate or vigorous) affects improvements in walking performance and cardiorespiratory fitness of patients with symptomatic lower-extremity peripheral artery disease (PAD). We searched the Embase, MEDLINE, Cochrane, Web of Science, and Google Scholar databases up to April 2021 and included randomized controlled trials reporting training therapies targeting exercise intensity (heart rate, oxygen consumption, or perceived exertion). The main outcomes were walking performance (pain-free [PFWD] and maximal [MWD] walking distance) and cardiorespiratory fitness (V̇O2peak). Secondary subanalyses examined the training modality (walking or other modalities) and the approach (high-intensity interval or moderate-intensity training). A total of 1132 patients were included. Light-to-moderate was superior to vigorous exercise intensity in improving MWD (223 m [95% CI 174 to 271], p < 0.00001; 153 m [95% CI 113 to 193], p < 0.00001; respectively) and PFWD (130 m [95% CI 87 to 173], p < 0.00001; 83 m [95% CI 61 to 104], p < 0.00001; respectively). When training modalities were considered, walking at a vigorous intensity (272 m [95% CI 207 to 337], p < 0.00001) showed the largest improvement in MWD compared to other exercise modalities. A larger increase in V̇O2peak was observed following vigorous (3.0 mL O2·kg-1·min-1 [95% CI 2.4 to 3.6], p < 0.00001) compared to light-to-moderate (1.1 mL O2·kg-1·min-1 [95% CI 0.4 to 1.7], p = 0.001) exercise intensity. These results indicate that vigorous was less effective than light-to-moderate intensity in improving walking performance, whereas it was more effective in improving V̇O2peak. When the training modalities were considered, walking at a vigorous intensity showed the greatest improvement in MWD. (PROSPERO Registration No.: CRD42020199469).

Supervised Exercise Training Improves 6 min Walking Distance and Modifies Gait Pattern during Pain-Free Walking Condition in Patients with Symptomatic Lower Extremity Peripheral Artery Disease.

This study aimed to investigate the effects of supervised exercise training (SET) on spatiotemporal gait and foot kinematics parameters in patients with symptomatic lower extremity peripheral artery disease (PAD) during a 6 min walk test. Symptomatic patients with chronic PAD (Fontaine stage II) following a 3 month SET program were included. Prior to and following SET, a 6 min walk test was performed to assess the 6 min walking distance (6MWD) of each patient. During this test, spatiotemporal gait and foot kinematics parameters were assessed during pain-free and painful walking conditions. Twenty-nine patients with PAD (65.4 ± 9.9 years.) were included. The 6MWD was significantly increased following SET (+10%; p ≤ 0.001). The walking speed (+8%) and stride frequency (+5%) were significantly increased after SET (p ≤ 0.026). The stride length was only significantly increased during the pain-free walking condition (+4%, p = 0.001), whereas no significant differences were observed during the condition of painful walking. Similarly, following SET, the relative duration of the loading response increased (+12%), the relative duration of the foot-flat phase decreased (-3%), and the toe-off pitch angle significantly increased (+3%) during the pain-free walking condition alone (p ≤ 0.05). A significant positive correlation was found between changes in the stride length (r = 0.497, p = 0.007) and stride frequency (r = 0.786, p ≤ 0.001) during pain-free walking condition and changes in the 6MWD. A significant negative correlation was found between changes in the foot-flat phase during pain-free walking condition and changes in the 6MWD (r = -0.567, p = 0.002). SET was found to modify the gait pattern of patients with symptomatic PAD, and many of these changes were found to occur during pain-free walking. The improvement in individuals' functional 6 min walk test was related to changes in their gait pattern.

[Vascular passport : a tool for secondary prevention among patients with peripheral artery disease]. / Passeport vasculaire : un outil pour la prévention secondaire des patients avec maladie artérielle périphérique.

Peripheral arterial disease (PAD) is a major health problem in Switzerland, as myocardial infarction or stroke, all three sharing common cardiovascular (CV) risk factors and similar pathophysiological mechanisms (atherosclerosis). Unfortunately, PAD is still often overlooked, despite being fraught with significant morbidity/mortality and increasing the patient's overall CV risk. It is therefore essential to improve secondary prevention in order to decrease this burden and the overall CV risk of the patient. We will review the treatment targets for CV risk factors as secondary prevention in patients with PAD and see how the use of a vascular passport may improve management.

La maladie artérielle périphérique (MAP) est une problématique de santé majeure en Suisse, au même titre que l'infarctus du myocarde ou l'AVC, tous les trois partageant des facteurs de risque cardiovasculaire (FRCV) communs et des mécanismes physiopathologiques similaires (athérosclérose). Malheureusement, l'importance de la MAP est encore souvent sous-estimée, alors qu'elle est grevée d'une morbidité et d'une mortalité importantes et augmente le risque cardiovasculaire (CV) global du patient. Il est capital d'améliorer la prévention secondaire afin de diminuer ce fardeau et le risque CV global du patient. Nous allons passer en revue les cibles de traitement des FRCV en prévention secondaire chez les patients avec MAP et voir comment l'utilisation d'un passeport vasculaire permet d'améliorer la prise en charge.

Improvement in 6-Minute Walking Distance after Supervised Exercise Training Is Related to Changes in Quality of Life in Patients with Lower Extremity Peripheral Artery Disease.

This study aimed to investigate the relationship between supervised exercise training (SET)-induced changes in treadmill performance and 6 min walking distance, and changes in general (physical and mental) self-perceived health-related quality of life (HRQoL) in symptomatic patients with lower extremity peripheral artery disease (PAD). This is an observational study investigating Fontaine stage II PAD patients participating in 3-month SET. Before and following SET, treadmill performance (pain-free (PFWD) and maximal (MWD)), and 6 min walking distance (6MWD) were assessed. Self-perceived HRQoL was assessed with the Medical Outcomes Study Short-Form 36 (SF-36). Ankle- and toe-brachial indexes were also measured. One-hundred forty-seven patients with PAD were included (64.9 ± 9.6 y, 70% men). After SET, PFWD (+102%, p ≤ 0.001), MWD (+87%, p ≤ 0.001), and 6MWD (+14%, p ≤ 0.001) significantly increased. All eight SF-36 subscale scores significantly improved following SET (p ≤ 0.04). SET significantly improved physical and mental component summaries of the SF-36 (p ≤ 0.001). Larger increases in 6MWD were associated with greater improvements in physical (ß = 0.19; p = 0.02) and mental (ß = 0.24; p = 0.005) component summaries of the SF-36. No significant relationship was observed between changes in treadmill performance and changes in physical and mental component summaries of the SF-36. These results show that improvements in 6MWD following SET are related to improvements in general self-perceived HRQoL in patients with symptomatic lower extremity PAD. On the contrary, changes in treadmill performance were not related to improvements in HRQoL. These results suggest that the 6 min walking test is an essential outcome measure to assess overall patient functional status following interventions in patients with PAD.