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

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.

The Intrarater and Interrater Reliability of Measures Derived from Cardiopulmonary Exercise Testing in Patients with Abdominal Aortic Aneurysms.

BACKGROUND: Patients with abdominal aortic aneurysms (AAAs) often have low exercise tolerance due to comorbidities and advanced age. Cardiopulmonary exercise testing (CPET) is predictive of postoperative morbidity and mortality in patients with AAA. We aimed to assess the intrarater and interrater reliability of both treadmill-based and cycle ergometer-based CPET variables. METHODS: Patients with an AAA (>3.5 cm) were randomized to a treadmill or bike CPET. Patients were asked to perform two separate CPETs seven days apart after a familiarization protocol. All CPETs were carried out using a ramp cycle or modified Bruce treadmill protocol with breath-by-breath gas analysis. RESULTS: Twenty-two male and 2 female patients, aged 73.6 ± 6.0 years, completed the study. Intrarater analysis (intraclass correlation coefficients) demonstrated high reliability on both the treadmill and bike for ventilatory anaerobic threshold (r = 0.834 and r = 0.975, respectively). All other CPET variables demonstrated high intrarater reliability on both modalities, bar the highest point for the ventilatory slope of oxygen (VE/VO2) on the treadmill (substantial agreement r = 0.755). Furthermore, interrater reliability demonstrated high agreement for ventilatory anaerobic threshold on both the treadmill and cycle (r = 0.983 and r = 0.905, respectively). All other CPET variables demonstrated high intrarater reliability on both modalities, with the exception of VO2Peak on the cycle ergometer (fair agreement r = 0.400). CONCLUSION: CPET in patients with AAAs is a reliable tool test and among CPET test reviewers for common testing modalities/protocols. These findings provide further support for the use of CPET, especially treadmill walking, as a clinical measure of perioperative cardiorespiratory fitness in patients with AAAs.

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.

Extracorporeal shockwave therapy for intermittent claudication: Medium-term outcomes from a double-blind randomised placebo-controlled pilot trial.

Objectives Peripheral arterial disease most commonly presents as intermittent claudication (IC). Early evidence has suggested that extracorporeal shockwave therapy is efficacious in the short term for the management of intermittent claudication. The objective of this pilot trial was to evaluate the medium-term efficacy of this treatment. Methods This double-blind randomised placebo-controlled pilot trial randomised patients with unilateral intermittent claudication in a 1:1 fashion to receive extracorporeal shockwave therapy or a sham treatment for three sessions per week over three weeks. Primary outcomes were maximum walking distance and intermittent claudication distance using a fixed-load treadmill test. Secondary outcomes included pre- and post-exertional ankle-brachial pressure indices, safety and quality of life assessed using generic (SF36, EQ-5D-3L) and disease-specific (vascular quality of life) measures. All outcome measures were assessed at 12 months post-treatment. Results Thirty participants were included in the study (extracorporeal shockwave therapy, n = 15; sham, n = 15), with 26 followed up and analysed at 12 months (extracorporeal shockwave therapy, n = 13; sham, n = 13). Intragroup analysis demonstrated significant improvements in maximum walking distance, intermittent claudication distance and post-exertional ankle-brachial pressure indices ( p < 0.05) in the active treatment group, with no improvements in pre-exertional ankle-brachial pressure indices. Significant improvements in quality of life were observed in 3 out of 19 domains assessed in the active group. A re-intervention rate of 26.7% was seen in both groups. Conclusions These findings suggest that extracorporeal shockwave therapy is effective in improving walking distances at 12 months. Although this study provides important pilot data, a larger study is needed to corroborate these findings and to investigate the actions of this treatment. ISRCTN: NCT02652078.

A Review of the Potential Local Mechanisms by Which Exercise Improves Functional Outcomes in Intermittent Claudication.

BACKGROUND: Intermittent claudication (IC) is a common condition which is associated with significant quality of life limitation. National Institute for Health and Care Excellence guidelines recommend a group-based supervised exercise program as the primary treatment option for claudication, based on clinical and cost effectiveness. This review aims to assess the mechanisms by which exercise improves outcomes in patients with IC. METHODS: MEDLINE, EMBASE, and PubMed were searched using the search strategy "claudication" [AND] "exercise" [AND] "mechanisms." Searches were limited from 1947 to October 2014. Only full-text articles published in the English language in adults (over 18 years of age) were eligible for the review. Any trial involving a nonsupervised exercise program was excluded. Abstracts identified by the database search were interrogated for relevance and citations from the shortlisted papers were hand searched for relevant references. RESULTS: The search yielded a total of 112 studies, of which 42 were duplicates. Forty-seven of the remaining 70 were deemed appropriate for inclusion in the review. Exercise is the first-line treatment for IC. Supervised exercise programs improve walking distances, endothelial and mitochondrial function, muscle strength, and endurance. Furthermore, it leads to a generalized improvement in cardiovascular fitness and overall quality of life. CONCLUSIONS: The mechanism by which exercise improves outcome in claudicants is complicated and multifactorial. Further research is required in this area to fully elucidate the precise and predominant mechanisms and to assess whether targeted exercise program modification maximizes mechanism efficacy and patient outcome.

A Systematic Review of the Uptake and Adherence Rates to Supervised Exercise Programs in Patients with Intermittent Claudication.

BACKGROUND: Intermittent claudication (IC) is a common and debilitating symptom of peripheral arterial disease and is associated with a significant reduction in a sufferer's quality of life. Guidelines recommend a supervised exercise program (SEP) as the primary treatment option; however, anecdotally there is a low participation rate for exercise in this group of patients. We undertook a systematic review of the uptake and adherence rates to SEPs for individuals with IC. METHODS: The MEDLINE, Embase, and PubMed databases were searched up to January 2015 for terms related to supervised exercise in peripheral arterial disease. The review had 3 aims: first, to establish the rates of uptake to SEPs, second, the rates of adherence to programs, and finally to determine the reasons reported for poor uptake and adherence. Separate inclusion and/or exclusion criteria were applied in selecting reports for each aim of the review. RESULTS: Only 23 of the 53 potentially eligible articles for uptake analysis identified on literature searches reported any details of screened patients (n = 7,517) with only 24.2% of patients subsequently recruited to SEPs. Forty-five percent of screen failures had no reason for exclusion reported. Sixty-seven articles with 4,012 patients were included for analysis of SEP adherence. Overall, 75.1% of patients reportedly completed an SEP; however, only one article defined a minimal attendance required for SEP completion. Overall, 54.1% of incomplete adherence was due to patient withdrawal and no reason for incomplete adherence was reported for 16% of cases. CONCLUSIONS: Reporting of SEP trials was poor with regard to the numbers of subjects screened and reasons for exclusions. Only approximately 1 in 3 screened IC patients was suitable for and willing to undertake SEP. Levels of adherence to SEPs and definitions of satisfactory adherence were also lacking in most the current literature. Current clinical guidelines based on this evidence base may not be applicable to most IC patients and changes to SEPs may be needed to encourage and/or retain participants.

Preferred exercise modalities in patients with intermittent claudication.

Conventional supervised exercise programs (SEPs) for claudicants are traditionally based on time-constrained, group-based structured programs usually at a hospital site. Uptake of an SEP is poor, despite the high-level evidence demonstrating its clinical effectiveness; therefore, alternative forms of exercise programs are needed which are more acceptable to patients. This study aimed to explore a range of exercise modalities to determine patient preferences for exercise delivery on a national level. This was a questionnaire survey to identify and incorporate patient preferences when designing a multicenter nationwide health-service evaluation of patient preference to exercise in the United Kingdom's National Health Service (the PREFER study). Patients with documented stable intermittent claudication who were suitable for an SEP were given a questionnaire to fill out at their clinic visit. Data were recorded using the Bristol Online Survey tool (http://www.survey.bris.ac.uk/) and analyzed descriptively. Thirty complete questionnaires were analyzed. Participants were generally unilateral claudicants (80%) with symptoms for over 1 year (64%). Only 6 of the 30 patients had engaged in a lifelong routine of exercise. Eighty-seven percent of patients indicated that they had not taken part in an exercise program, but 73% of those indicated that they would be willing to participate to improve their walking. Most patients expressed a preference for a home exercise program (50%) followed by a hospital SEP. The majority of patients (43%) were happy to exercise 3 days per week using a walking-based program (53%). There was however no consensus on the duration or intensity of the exercise program. The SEP is the recommended first-line treatment for intermittent claudication patients; however, the vast majority of patients fail to engage with or complete an exercise program. This study demonstrates that exercise therapy should be individualized and take a patient-centered approach. Commissioning groups should incentivize hospitals and clinicians to engage with their patient populations to understand their needs and deliver an appropriate service.

"Intermittent claudication a real pain in the calf"-Patient experience of diagnosis and treatment with a supervised exercise program.

Intermittent claudication (IC) is a common condition which has severe impacts on quality of life, physical function, and mental health. Supervised exercise is the recommended first-line treatment for patients with this condition; however, these are not always feasible or accessible to patients. As the proportion of patients who have this treatment remains suboptimal, it is important to better understand the perception of exercise in this population. A gap in the literature exists about the barriers and facilitators to exercise in patients completing, dropping out of, or declining an exercise program. A qualitative analysis was undertaken to understand this further. Twenty-five patients were interviewed face to face, 10 who had completed exercise, 10 who had declined, and 5 who had dropped out of an exercise program. Three major themes emerged from the data, IC, and perception to exercise and experience or beliefs of the exercise program.Addressing the barriers and facilitators to exercise in patients with IC is crucial in optimizing the delivery and uptake of exercise programs. More education or time investment is needed with these patients during initial diagnostic to help overcome perceived barriers and emphasis healthy behavioral changes.