Alternative exercise programmes for the treatment of intermittent claudication - from unsupervised home-based walking to supervised high-intensity interval cycling

Supervised exercise programmes (SEP) for intermittent claudication (IC) suffer from low provision and uptake rates. As such, alternative interventions should be explored, such as home-based exercise programmes (HEP) and high-intensity interval training (HIIT). This thesis aimed to synthesise the current evidence for HEPs and provide evidence-based recommendations for practitioners. A second systematic review was performed to synthesise the evidence for HIIT, designed to inform a cohort study considering the safety, tolerability, feasibility, efficacy and acceptability of HIIT for patients with IC.Evidence from this thesis suggests that HEPs are potentially efficacious as long as they are sufficiently structured and include appropriate; frequency (≥3x week), intensity (moderate-maximal claudication), time (20 increasing to 60 minutes) and type (walking) principles. They also need to be supported by including education, feedback, goal setting, action planning and monitoring. However, this HEP structure is currently untested, meaning further adequately powered research is required.Evidence for HIIT was limited but suggested that low-volume, short-duration protocols were efficacious. This informed the first cohort study which identified that a large proportion of patients were unable to achieve a maximal effort cardiopulmonary exercise test, likely due to deconditioning. This meant that conventional HIIT was not feasible for these patients and as such, they were excluded, leading to a low completion rate. However, these deconditioned patients may accrue the most benefit. As such, the exclusion criteria were altered, and these patients were included and provided with a personalised, submaximal HIIT programme. A second cohort study was performed to consider the feasibility of this slightly altered programme. The findings suggest that the exclusion criteria are now appropriate and that the HIIT protocol is feasible, tolerable and acceptable, whilst also being potentially safe and efficacious. These findings should be confirmed before larger randomised trials of HIIT versus SEPs are performed

Extracorporeal Shockwave for Intermittent Claudication and Quality of Life: A Randomized Clinical Trial

Importance Intermittent lower limb claudication limits function and quality of life. Supervised exercise programs are not readily available, and a noninvasive alternative is needed.Objective To assess extracorporeal corporeal shockwave therapy in improving quality of life in patients with claudication.Design, Setting, and Participants In this double-blind, placebo-controlled randomized clinical trial, patients in the outpatient setting at a single tertiary center for vascular surgery were randomized in a 1:1 ratio to extracorporeal shockwave therapy or placebo therapy with no shockwaves delivered. Recruitment was between June 2015 and January 2020, with 12-week follow-up ending in March 2020. A convenience sample of patients with claudication and conservative treatment requirements who refused or were unable to participate in supervised exercise were eligible. Patients receiving anticoagulation therapy or with an active cancer were excluded. Of 522 patients screened, 389 were eligible, 138 were enrolled, and 110 completed follow-up and were included in the primary analysis. Statistical analysis was completed by May 2021.Intervention In the intervention group, patients received 100 impulses of 0.1mJ/mm/cm2 in an area of the gastrocnemius muscle 3 times weekly for 3 weeks. The steps for treatment were replicated for the control group without delivering the treatment.Main Outcomes and Measures The primary outcome was the Physical Functioning domain of the 36-item Short-Form Quality of Life Questionnaire at 12-week follow-up. Secondary outcomes included walking distances, ankle brachial pressure index, and other quality-of-life measures.Results Of 138 patients recruited and randomized, 92 (67%) were male, and the mean (SD) age of the study population was 67 (9.6) years. The intervention group had a significantly higher physical function score at 12 weeks (estimated median difference 3.8; 95% CI, 0.0-7.7; P = .03). However, this significance did not remain when adjusting for covariates. At 12 weeks, the intervention group had significantly longer pain-free and maximum walking distances (pain-free estimated median difference, 34.1, 95% CI, 11.4-56.8; P = .004; maximum estimated median difference, 51.4; 95% CI, 10.7-86.5; P = .01).Conclusions and Relevance To our knowledge, this is the first double-blind, placebo-controlled, randomized clinical trial to consider extracorporeal shockwave therapy for the management of intermittent claudication. It demonstrated efficacy for walking distances, may have a positive effect on quality of life, and may provide a safe, noninvasive alternative therapy for patients with intermittent claudication

Provision of NICE recommended Varicose Vein Treatment in the NHS

Background: Standardization of access to treatment and compliance with clinical guidelines are important to ensure the delivery ofhigh-quality care to people with varicose veins. In the National Health Service (NHS) in England, commissioning of care for people withvaricose veins is performed by Clinical Commissioning Groups (CCGs) and clinical guidelines have been developed by the NationalInstitute for Health and Care Excellence (NICE CG168). The Evidence-Based Intervention (EBI) programme was introduced in theNHS with the aim of improving care quality and supporting implementation of NICE CG168. The aim of this study was to assessaccess to varicose vein treatments in the NHS and the impact of EBI.Methods: CCG policies for the delivery of varicose vein treatments in the NHS in England were obtained from 2017 (before EBIintroduction) and 2019 (after EBI introduction) and categorized by two independent reviewers into levels of compliance with NICECG168. Hospital Episode Statistics data were compared with the NICE commissioning model predictions. A quality-adjusted life-yearwas valued at £20 000 (Euro 23 000 15 November 2022).Results: Despite the introduction of the EBI programme, CCG compliance with NICE CG168 fell from 34.0 per cent (64 of 191) to 29.0 per cent(55 of 191). Some 33.0 per cent of CCG policies (63 of 191) became less compliant and only 7.3 per cent (14 of 191) changed to become fullycompliant. Overall, 66.5 per cent of CCGs (127 of 191) provided less than the recommended intervention rate before EBI and this increasedto 73.3 per cent (140 of191) after EBI. The overall proportion of patients estimated to require treatment annually who received treatmentfell from 44.0 to 37.0 per cent. The associated estimated loss in net health benefit was between £164 and 174 million (Euro 188 million and199 million 15 November 2022) over 3 years. A compliant policy was associated with a higher intervention rate; however, commissioningpolicy was associated with only 16.8 per cent of the variation in intervention rate (R2=0.168, P<0.001).Conclusion: Many local varicose vein commissioning policies in the NHS are not compliant with NICE CG168. More than half of patientswho should be offered varicose vein treatment are not receiving it, and there is widespread geographical variation. The EBI programmehas not been associated with any improvement in commissioning or access to varicose vein treatment

Does exercise training prescription based on estimated heart rate training zones exceed the ventilatory anaerobic threshold in patients with coronary heart disease undergoing usual-care cardiovascular rehabilitation?: A United Kingdom perspective

Background: In the United Kingdom (UK), exercise intensity is prescribed from a fixed percentage range (% heart rate reserve; %HRR) in cardiac rehabilitation (CR) programmes. We aimed to determine the accuracy of this approach by comparing it with an objective, threshold-based approach incorporating the accurate determination of ventilatory anaerobic threshold (VAT). We also aimed to investigate the role of baseline cardiorespiratory fitness status, and exercise testing mode dependency (cycle v treadmill ergometer) on these relationships. Design/Methods: A maximal cardiopulmonary exercise test was conducted on a cycle ergometer or a treadmill before and following usual-care circuit training from two separate CR programmes from a single region in the UK. The heart rate corresponding to VAT was compared to current heart rate-based exercise prescription guidelines. Results: We included 112 referred patients (61 years [59-63]; body mass index 29 kg∙m-2 [29-30]; 88% male). There was a significant but relatively weak correlation (r=0.32; P=0.001) between measured and predicted %HRR, and values were significantly different from each other (P=0.005). Within this cohort, we found that 54% of patients had their VAT identified outside of the 40-70% predicted HRR exercise training zone. In the majority of participants (45%), the VAT occurred at an exercise intensity 70% HRR. VAT was significantly higher on the treadmill than the cycle ergometer (P<0.001). Conclusion: In the UK, current guidelines for prescribing exercise intensity are based on a fixed percentage range. Our findings indicate that this approach may be inaccurate in a large proportion of patients undertaking CR

A systematic review of high-intensity interval training as an exercise intervention for intermittent claudication

BackgroundIntermittent claudication (IC) is the most common symptom of peripheral arterial disease, which significantly affects walking ability, functional capacity and quality of life. Supervised exercise programs (SEP) are recommended as first-line treatment, but recruitment and adherence rates are poor. The time required to complete a SEP is the most common barrier to participation cited by patients who decline. High-intensity interval training (HIIT) is more time efficient than current SEPs and therefore has the potential to overcome this barrier. We conducted a systematic review to appraise the evidence for HIIT programs for IC.MethodsMEDLINE, Embase, and CENTRAL databases were searched for terms related to HIIT and IC. Randomized and nonrandomized trials that investigated HIIT for the treatment of IC were included, with no exclusions based on exercise modality, protocol, or use of a comparator arm. Outcome measures were walking distances, peak oxygen uptake, recruitment and adherence rates, and quality of life. The risk of bias was assessed using the Cochrane tool and study quality using a modified Physiotherapy Evidence Database scale.ResultsNine articles reporting eight studies were included in the review. HIIT seems to improve walking distances and oxygen uptake in relation to controls, with improvements attainable in just 6 weeks. When HIIT was compared with low-intensity exercise, it seemed that longer low-intensity programs were required to obtain similar benefits to those from short-term HIIT.ConclusionsInitial evidence suggests that HIIT may provide benefits for patients with IC. Initially, pilot studies of low-volume, short-term HIIT vs usual SEPs are required. This strategy will allow for larger randomized, controlled trials to be appropriately designed and adequately powered to further explore the potential benefits of HIIT in IC

Exercise training for intermittent claudication:a narrative review and summary of guidelines for practitioners

Peripheral artery disease (PAD) is caused by atherosclerotic narrowing of the arteries supplying the lower limbs often resulting in intermittent claudication, evident as pain or cramping while walking. Supervised exercise training elicits clinically meaningful benefits in walking ability and quality of life. Walking is the modality of exercise with the strongest evidence and is recommended in several national and international guidelines. Alternate forms of exercise such as upper- or lower-body cycling may be used, if required by certain patients, although there is less evidence for these types of programmes. The evidence for progressive resistance training is growing and patients can also engage in strength-based training alongside a walking programme. For those unable to attend a supervised class (strongest evidence), home-based or ‘self-facilitated’ exercise programmes are known to improve walking distance when compared to simple advice. All exercise programmes, independent of the mode of delivery, should be progressive and individually prescribed where possible, considering disease severity, comorbidities and initial exercise capacity. All patients should aim to accumulate at least 30 min of aerobic activity, at least three times a week, for at least 3 months, ideally in the form of walking exercise to near-maximal claudication pain

Home-based exercise programmes for individuals with intermittent claudication: A protocol for an updated systematic review and meta-analysis

Background: The aim of this updated review is to consider the evidence base for the effectiveness of home-based exercise programmes (HEP) as a treatment option for improving walking distance in patients with IC.Methods: The Medline, EMBASE, CINAHL, PEDro and Cochrane CENTRAL databases will be searched for terms including “intermittent claudication”, “peripheral arterial disease”, “home-based exercise” and “home-based walking”. No date restrictions will be used but only articles in the English language will be included. Both randomised and non-randomised trials of HEP’s versus a comparator arm will be included, and a meta-analysis using only the randomised controlled trials will be attempted if the assumptions of heterogeneity are met. Data extraction will include study details, sample description, intervention description, length of follow up and outcomes measures. The primary outcome measure is objectively measured maximal walking distance or time, with secondary outcome measures including pain-free walking distance or time, changes in physical activity and quality of life. We will also provide a narrative description of the effective components of a home-based exercise intervention which can aid future recommendations. Conclusion: Overall, this proposed review and meta-analysis aims to provide a comprehensive and complete overview of the evidence base for HEP’s, which can aid clinicians in the management of their patients.PROSPERO registration number: CRD4201809124

Presurgery conditioning interventions (prehabilitation) in adults undergoing lower limb surgery for peripheral arterial disease

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:To assess the effectiveness of prehabilitation (preoperative exercise, either alone or in combination with nutritional or psychological interventions or both) on postoperative outcomes in adults with PAD undergoing open lower limb surgery

Presurgery exercise-based conditioning interventions (prehabilitation) in adults undergoing lower limb surgery for peripheral arterial disease (Review)

Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Background: Lower limb peripheral arterial disease (PAD) is a type of cardiovascular disease where the blood vessels that carry the blood to the legs are hardened and narrowed. The most severe manifestation of PAD is critical limb ischaemia (CLI). This condition results in symptoms of intractable rest pain, non-healing wounds and ulceration, gangrene or both. PAD affects more than 200 million people worldwide and approximately 3% to 5% of people aged over 40 have PAD, rising to 18% in people over 70 years of age. Between 5% to 10% of symptomatic PAD patients will progress to CLI over a five-year period and the five year cumulative incidence rate for asymptomatic patients with PAD deteriorating to intermittent claudication is 7%, with 21% of these progressing to CLI. Treatment options include angioplasty, bypass or amputation of the limb, when life or limb is threatened. People with CLI have a high risk of mortality and morbidity. The mortality rates during a surgical admission are approximately 5%. Within one year of surgery, the mortality rate rises to 22%. Postoperative complications are as high as 30% and readmission rates vary between 7% to 18% in people with CLI. Despite recent advances in surgical technology, anaesthesia and perioperative care, a proportion of surgical patients have a suboptimal recovery. Presurgery conditioning (prehabilitation) is a multimodal conditioning intervention carried out prior to surgery using a combination of exercise, with or without nutritional or psychological interventions, or both. The use of prehabilitation is gaining momentum, particularly in elderly patients undergoing surgery and patients undergoing colorectal cancer surgery, as a means of optimising fitness to improve the prognosis for people undergoing the physiological stress of surgery. People with PAD are characterised by poor mobility and physical function and have a lower level of fitness as a result of disease progression. Therefore, prehabilitation may be an opportunity to improve their recovery following surgery. However, as multimodal prehabilitation requires considerable resources, it is important to assess whether it is superior to usual care. This review aimed to compare prehabilitation with usual care (defined as a preoperative assessment, including blood and urine tests). The key outcomes were postoperative complications, mortality and readmissions within 30 days of the surgical procedure, and one-year survival rates. Objectives: To assess the effectiveness of prehabilitation (preoperative exercise, either alone or in combination with nutritional or psychological interventions, or both) on postoperative outcomes in adults with PAD undergoing open lower limb surgery. Search methods: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 25 September 2019. Selection criteria: We considered all published and unpublished randomised controlled trials (RCTs) comparing presurgery interventions and usual care. Primary outcomes were postoperative complications, mortality and readmission to hospital within 30 days of the surgical procedure. Data collection and analysis: Two review authors independently reviewed all records identified by the searches conducted by the Cochrane Vascular Information Specialist. We planned to undertake data collection and analysis in accordance with recommendations described in the Cochrane Handbook for Systematic Reviews of Interventions. Main results: We found no RCTs that met the inclusion criteria for this review. Authors' conclusions: We found no RCTs conducted to determine the effects of prehabilitation on mortality or other postoperative outcomes when compared to usual care for patients with PAD. As a consequence, we were unable to provide any evidence to guide the treatment of patients with PAD undergoing surgery. To perform a randomised controlled trial of presurgery conditioning would be challenging but trials are warranted to provide solid evidence on this topic

A Systematic Review of Exercise Prescription in Patients with Intermittent Claudication: Does Pain Matter?

Background: Current guidelines for intermittent claudication advocate exercise at moderate to maximal claudication pain. However, adherence rates to supervised exercise programmes (SEP) remain poor and claudication pain is a contributing factor. Limited evidence suggests that moderate or pain-free exercise may be just as beneficial and may be better tolerated. However, it remains unclear what ‘level’ of claudication pain is optimal for improving functional outcomes. We therefore conducted a systematic review to synthesise the evidence for exercise prescribed at different levels of claudication pain. Methods: The CENTRAL, MEDLINE, Embase and CINAHL databases were searched up to October 2020. Randomized controlled trials (RCTs) that directly compared at least 2 different intensities of claudication pain were included. Outcome measures included walking performance, adherence, quality of life and vascular function. Results: Of 1,543 search results, 2 studies were included. Maximal walking distance improved by 100–128% in the moderate-pain SEP groups, and by 77–90% in the pain-free SEP groups. Importantly, there were no significant differences between the moderate-pain and pain-free SEP groups in either study for improvements in walking performance, though comparison to a maximal-pain SEP group was not made. Conclusions: The efficacy of SEPs for patients with intermittent claudication is irrefutable, though there is no consensus on the optimal level of pain. Therefore, adequately powered RCTs are required to compare the effect of pain-free SEPs, moderate-pain SEPs and maximal-pain SEPs on functional outcomes. (PROSPERO ID: CRD42020213684)