Network Meta-Analysis of Trials Testing If Home Exercise Programs Informed by Wearables Measuring Activity Improve Peripheral Artery Disease Related Walking Impairment.

Background: This study aimed to investigate whether home exercise programs informed by wearable activity monitors improved walking ability of patients with peripheral artery disease (PAD). Methods: A systematic literature search was performed to identify randomised controlled trials (RCT) testing home exercise that were or were not informed by wearable activity monitors. The primary outcome was the change in walking distance measured by a six-minute walking test or treadmill test over the course of the trial. Network meta-analysis (NMA) was performed using the gemtc R statistical package. The risk of bias was assessed using Cochrane tool for assessing risk of bias in RCTs (RoB 2.0). Results: A total of 14 RCTs involving 1544 participants were included. Nine trials used wearable activity monitors to inform the home exercise program tested, while five trials did not use wearable activity monitors to inform the home exercise program tested. Overall quality assessment showed 12 trials to be at low risk of bias and two trials at high risk of bias. Home exercise programs informed by wearable activity monitors significantly improved walking distance compared to non-exercise controls (Mean difference, MD: 32.8 m [95% credible interval, CrI: 6.1, 71.0]) but not compared to home exercise programs not informed by wearable activity monitors (MD: 4.7 m [95% CrI: -38.5, 55.4]). Conclusions: Home exercise informed by wearable activity monitors improve walking ability of patients with PAD. It is, however, unclear if activity monitoring informed exercise programs are more effective than exercise programs not using activity monitors.

[Randomized study of tolerability, safety and efficacy of Pletax in intermittent claudication]. / Randomizirovannoe issledovanie perenosimosti, bezopasnosti i éffektivnosti preparata Pletaks pri peremezhaiushcheisia khromote.

AIM: This study was aimed at assessing tolerability, safety and therapeutic efficacy of Pletax® (cilostazol) compared with Trental® (pentoxifylline) in patients with moderate-to-severe intermittent claudication. PATIENTS AND METHODS: The study included a total of one hundred 40-to-65-year-old patients presenting with confirmed diagnosis of moderate-to-severe intermittent claudication. Depending on the therapeutic regimen, the patients were divided into two groups. Group 1: 50 patients orally took Pletax® (cilostazol) at a dose of 100 mg twice daily 30 minutes before meals or 2 hours after meals together with conventional therapy. Group 2: 50 patients took oral Trental® (pentoxifylline) in a dose of 400 mg 3 times daily 30 minutes before meals or 2 hours after meals along with conventional therapy. The duration of the follow up period amounted to 24 weeks for both groups. The treadmill test was carried out at room temperature, with the running track tilt angle of 0° at a speed of 3 km/h. The primary parameters of efficacy were as follows: the dynamics of the minimal walking distance (a distance walked by the patient until the appearance of pain in the extremity) and dynamics of the maximal walking distance (a distance walked by the patients until full stop due to pain in the extremity). RESULTS: Analysing efficacy demonstrated higher results of Pletax® compared with Trental®. The obtained findings suggested that Pletax® showed a significant clinical effect as soon as at 2 weeks, followed by advantage during the whole period of follow up. Analysing the parameters of the minimal and maximal walking distances in the group of patients taking Pletax® demonstrated clear superiority over the Trental® group as soon as by week 2 of administration, which preserved during the whole follow-up period. The minimal pain-free walking distance in the Pletax group at baseline amounted to 92.9±83.4 m (Trental group - 92.3±78.4; p=0.3), followed by an increase at week 8 to 126±115 m (Trental group - 116±96.3; p=0.51), at week 16 to 136±116 m (Trental group - 118±95.5; p=0.04), at week 24 to 149±126 b (Trental group - 127±98.9; p=0.01). At the same time, the effect of Pletax® and Trental® on the secondary parameter of efficacy, i.e., the ankle-brachial index was comparable: at baseline - 0.472 and 0.482 (p=0.28), at 2 weeks - 0.48 and 0.483 (p=031), at 8 weeks - 0.49 and 0.485 (p=0.74), at 16 weeks - 0.494 and 0.492 (p=0.2), at 24 weeks - 0.501 and 0.496 (p=0.45). CONCLUSION: The obtained findings demonstrated advantages of Pletax® over Trental®, manifesting themselves in the achievement of the highest parameters by such criteria as the minimal and maximal walking distance. High safety and efficacy of Pletax® were confirmed by low frequency of unfavourable events during therapy.

Effect of conservative treatment in aortoiliac occlusive disease.

Objective: To determine the effect of primary conservative treatment without revascularization in patients with proven aortoiliac occlusive disease (AIOD) presenting with intermittent claudication (IC).Background: The initial treatment of IC should focus on supervised exercise therapy (SET) and pharmacotherapy. Nowadays, primary endovascular revascularization (EVR) has become increasingly popular in patients with all types of AIOD. But in daily practice, EVR is often performed without initially extensive exercise.Method: This is a single centre retrospective study from December 2012 to September 2017. Primary outcomes were maximum walking distance (MWD) and patient satisfaction. Secondary outcomes were revascularization rate and mortality.Results: Twenty-four patients were included. Mean age was 64 years (SD: 9). Mean follow-up was 28 months (SD: 17). Nineteen patients (80%) had SET. In 18 (75%) patients, the MWD was improved compared to the initial situation. In five (21%) patients, the MWD stayed the same. The MWD of one (4%) patient decreased. Overall satisfaction rate was 87%. Three patients (13%) were not satisfied with the conservative treatment and eventually got an EVR. There was no disease related death.Conclusions: Conservative treatment, especially with SET, has acceptable subjective symptom outcomes in selected patients with AIOD. It could be a good alternative treatment for certain patients with AIOD and IC.

Associations of exercise ankle-brachial index, pain-free walking distance and maximum walking distance with the Peripheral Artery Questionnaire: Finding from the PORTRAIT PAD Registry.

An exercise ankle-brachial index (ABI) test can provide further insight into the functional significance of peripheral artery disease (PAD). The variability in its use, associated patient factors and its relation to patients' symptoms are unknown. From the international PORTRAIT registry, we identified 1131 patients with PAD. We fit a hierarchical logistic regression model, adjusting for patient factors, country and site, to examine predictors of and variation in ordering exercise ABI testing. We also examined the associations between test components and health status as quantified by the Peripheral Artery Questionnaire (PAQ) using semi-parametric regression methods. Testing was ordered in 22% in the United States versus 80% in the Netherlands and 90% in Australia. Testing was likely to be performed if the patient was male, younger, had typical symptoms and a higher resting ABI, with substantial variability across sites (median odds ratio=5.9, 95% CI: 3.2-19.5). Adjusting for country and site, the resting ABI and all exercise ABI metrics were associated with the PAQ Physical Limitation score. In addition, important components of the test, namely time to onset of claudication, pain-free walking distance (PFWD), and maximum walking distance (MWD), were also associated with PAQ Symptoms and Summary scores. More importantly, even after adjusting for resting ABI, a patient with a post-exercise ABI of 0.29 (25th percentile), compared to 0.61 (75th percentile), achieved 4.4 (95% CI: 0.4-8.4, p=0.031) points less on the PAQ Physical Limitation score. Exercise ABI test use is remarkably variable, and less used in the United States. Its data, specifically PFWD and MWD, might help in objectively assessing the impact of PAD on patients' functioning and quality of life.

New insight of the efficacy trimetazidine in patients with peripheral arterial disease: a meta-analysis.

BACKGROUND: This review aims to examine the impact of trimetazidine on skeletal muscle function in patients suffering from peripheral artery disease (PAD). METHODS: We searched for studies, both experimental and observational research, concerning the comparison of trimetazidine administration to placebo/standard of care in patients with PAD in PubMed, ScienceDirect, and Cochrane. Meta-analyses of the included studies were performed using Review Manager v5.4. Clinical parameters [ankle-brachial index (ABI) and maximum walking distance (MWD)] were analyzed. RESULTS: Three observational studies involving 378 participants with PAD satisfied predefined criteria. There was no substantial difference between the examined groups' on ABI (pre- and post-intervention) (MD = - 0.06 [- 0.19 to 0.07], p = 0.38, I2 = 90%). Meanwhile, MWD improvement was significantly higher (MD = 14.15 [6.05-22.25], p = 0.0006, I2 = 37%) in trimetazidine group than in the control group. CONCLUSIONS: Current evidence from our meta-analysis suggests the beneficial role of trimetazidine's anti-ischemic effect in PAD patients by improving MWD, while it has an insignificant influence on ABI.

Network Meta-Analysis Comparing the Outcomes of Treatments for Intermittent Claudication Tested in Randomized Controlled Trials.

Background No network meta-analysis has considered the relative efficacy of cilostazol, home exercise therapy, supervised exercise therapy (SET), endovascular revascularization (ER), and ER plus SET (ER+SET) in improving maximum walking distance (MWD) over short- (<1 year), moderate- (1 to <2 years), and long-term (≥2 years) follow-up in people with intermittent claudication. Methods and Results A systematic literature search was performed to identify randomized controlled trials testing 1 or more of these 5 treatments according to Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. The primary outcome was improvement in MWD assessed by a standardized treadmill test. Secondary outcomes were adverse events and health-related quality of life. Network meta-analysis was performed using the gemtc R statistical package. The Cochrane collaborative tool was used to assess risk of bias. Forty-six trials involving 4256 patients were included. At short-term follow-up, home exercise therapy (mean difference [MD], 89.4 m; 95% credible interval [CrI], 20.9-157.7), SET (MD, 186.8 m; 95% CrI, 136.4-237.6), and ER+SET (MD, 326.3 m; 95% CrI, 222.6-430.6), but not ER (MD, 82.5 m; 95% CrI, -2.4 to 168.2) and cilostazol (MD, 71.1 m; 95% CrI, -24.6 to 167.9), significantly improved MWD (in meters) compared with controls. At moderate-term follow-up, SET (MD, 201.1; 95% CrI, 89.8-318.3) and ER+SET (MD, 368.5; 95% CrI, 195.3-546.9), but not home exercise therapy (MD, 99.4; 95% CrI, -174.0 to 374.9) or ER (MD, 84.2; 95% CrI, -35.3 to 206.4), significantly improved MWD (in meters) compared to controls. At long-term follow-up, none of the tested treatments significantly improved MWD compared to controls. Adverse events and quality of life were reported inconsistently and could not be meta-analyzed. Risk of bias was low, moderate, and high in 4, 24, and 18 trials respectively. Conclusions This network meta-analysis suggested that SET and ER+SET are effective at improving MWD over the moderate term (<2 year) but not beyond this. Durable treatments for intermittent claudication are needed.

Real-life adaptations in walking patterns in patients with established peripheral arterial disease assessed using a global positioning system in the community: a cohort study.

OBJECTIVE: Lower extremity peripheral arterial disease (PAD) is a chronic condition most commonly presenting with intermittent claudication (IC). Intermittent claudication limits walking ability and may negatively affect health-related quality of life. Treadmill assessment of maximal walking distance (MWD) is the gold standard to assess PAD symptom severity. Despite being a well-established and reproducible tool, it may be inappropriate (due to frailty or fear) for some patients and only describes maximal abilities for a single walk test. Global positioning systems (GPS) have been proposed as reliable and reproducible tool to measure total, mean and maximal walking distances in patients with PAD, in the community setting. Using GPS, our study attempted to explore what happens to the walking ability of patients with IC following no intervention under 'real-life' conditions. DESIGN AND METHODS: Using the GlobalSat DG100 GPS, forty-three patients (69 ± 9 years; nine female; no invasive interventions or rehabilitation) undertook two 60-min walking assessments, 6 months apart. Assessments took place in community spaces that had even terrain, no tall trees or buildings and were free from motorized vehicles. Global positioning systems-measured maximum walking distance was the main study outcome measure. RESULTS: Over the 6-month period, patients demonstrated significantly shorter GPS-measured, mean (552 m versus 334 m; P = 0·02) and maximum (714 m versus 545 m; P = 0·04) walking distances, stopping also more frequently (nine versus five times; P = 0·03). CONCLUSIONS: Given the reported symptom progression, we advocate early intervention (e.g. exercise interventions) combined with frequent patient monitoring in attempts to maintain or improve walking ability.

Upper versus lower limb exercise training in patients with intermittent claudication: a systematic review.

Lower extremity (LE) exercise training has been shown to contribute to improvements in Maximum Walking Distance (MWD), Claudication Distance (CD), peak oxygen uptake (VO2peak) and Quality of Life (QoL) in patients with intermittent claudication (IC). However, little is known regarding the efficacy of upper extremity (UE) exercise training in comparison to the widely used LE training. The objective of this systematic literature review is to identify and synthesize the available literature on the effects of UE versus LE exercises using the International Classification of Functioning (ICF) conceptual framework. A total of 6 randomized controlled trials comparing UE to LE exercises were included in this study. Two of the articles were considered to be of high quality using the PEDro grading list. Both UE and LE training groups demonstrated significant improvements in MWD, CD, VO2peak and QoL in comparison to the control group but LE was not better than UE training. This supports the use of UE training as an alternative to LE, which could provide symptomatic relief to patients with IC without the discomfort caused during the LE training.

Comparison of two walk tests in determining the claudication distance in patients suffering from peripheral arterial occlusive disease.

BACKGROUND: The purpose of this study was to compare the six-minute walk test (6MWT) and the incremental shuttle walk test (ISWT) in terms of the initial onset of pain (IOP), maximal claudicating pain (MCP), maximum walking distance (MWD), initial ankle brachial index (IABI), post ankle brachial index (PABI), and difference in ankle brachial index (DFABI), as well as to correlate changes in IOP and MWD, MCP and MWD, IABI and MWD, PABI and MWD, and DFABI and MWD in the 6MWT and ISWT. MATERIALS AND METHODS: Participants (n = 19, 17 men and 2 women) were randomly allocated to the 6MWT or ISWT and crossed over to the other test after 24 hours. The baseline ankle brachial index (ABI) measurements were taken using the Doppler, following which the participants performed the tests. Post-test MWD, IOP, MCP, and ABI were measured. The paired t test was used pre- and post the walk test and the Pearson correlation was used to find any relationship between the desired variables. RESULTS: The paired t test at 95% confidence interval for IABI and PABI (P > 0.05) was insignificant for the 6MWT and ISWT. The Pearson correlation of MWD with IOP showed a fair correlation, and the correlation of MWD to MCP showed a strong correlation in ISWT. CONCLUSION: ISWT can be of vital importance as a tool to assess the functional status of patients suffering from Peripheral Arterial Occlusive Disease (PAOD) in both the clinical and research areas, and reflects a better assessment of the functional limitation when walking with PAOD as compared to the 6MWT.