Randomized controlled trial of vacuum therapy for intermittent claudication.

OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program. METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life. RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups. CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.

User Preferences for Mobile Health Interventions: A Survey among Intermittent Claudication Patients and Their Physical Therapists.

BACKGROUND: Smartphone apps provide novel ways for triggering lifestyle change by coupling objective measurements of health behavior with tailored feedback. Little is known about end-user preferences regarding the content of mobile health (mHealth) interventions. The aim of this study was to assess smartphone use and preferences regarding app content among intermittent claudication patients and their treating physical therapists. METHODS: A cross-sectional survey was sent via an internal email system to 1,514 physical therapists specialized in treating patients with intermittent claudication. They were asked to complete one questionnaire themselves and administer a second to their intermittent claudication patients currently under treatment. Data on participant characteristics and smartphone use were collected from all respondents. The preferred app components were obtained from participants owning a smartphone. Binary logistic regression analysis was used to explore the adjusted association between age and attained educational level, and smartphone use. RESULTS: The response rate of therapists was 40.8% (617/1,514), and a total of 488 patients completed the survey. After excluding incomplete forms, a total of 615 physical therapist forms and 483 patient forms were analyzed. Overall, 40.6% of patients and 95% of therapists owned a smartphone. Higher educational level was associated with smartphone ownership (adjusted odds ratio = 2.46, 95% confidence interval (CI) = 1.41-4.27, P = 0.001). Compared to patients aged ≥75 years, lower age was associated with higher odds of owning a smartphone (adjusted odds ratios for patients aged ≤54 years = 21.27, 95% CI = 6.82-66.30, P < 0.001; aged 55-64 years = 4.76, 95% CI = 2.52-9.00, P < 0.001; and aged 65-74 years = 2.58, 95% CI = 1.54-4.33, P < 0.001). The most preferred app components for intermittent claudication patients in possession of a smartphone included monitoring treadmill-measured walking distances (71%), global positioning system tracking of walks (50%), and daily physical activity monitoring (49%). Physical therapists were most interested in global positioning system tracking of walks (89%), daily physical activity monitoring (82%), keeping track of treadmill-measured walking distance (79%), help with smoking cessation (65%). CONCLUSIONS: Smartphone ownership is associated with younger age and a higher educational level in patients with intermittent claudication. This study provides a framework of end-user preferences regarding desired features to guide the development of an app to potentiate health outcomes of intermittent claudication treatment.

Safety of supervised exercise therapy in patients with intermittent claudication.

BACKGROUND: Supervised exercise therapy (SET) is recommended as the primary treatment for patients with intermittent claudication (IC). However, there is concern regarding the safety of performing SET because IC patients are at risk for untoward cardiovascular events. The Dutch physical therapy guideline advocates cardiac exercise testing before SET, if indicated. Perceived uncertainties concerning safety may contribute to the underuse of SET in daily practice. The objective of this review was to analyze the safety of supervised exercise training in patients with IC. METHODS: Two authors independently studied clinical trials investigating SET. Data were obtained from MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials. Complication rates were calculated and expressed as number of events per number of patient-hours. The usefulness of cardiac screening before SET was evaluated in a subanalysis. RESULTS: Our search strategy revealed 2703 abstracts. We selected 121 articles, of which 74 met the inclusion criteria. Studies represent 82,725 hours of training in 2876 IC patients. Eight adverse events were reported, six of cardiac and two of noncardiac origin, resulting in an all-cause complication rate of one event per 10,340 patient-hours. CONCLUSIONS: SET can safely be prescribed in patients with IC because an exceedingly low all-cause complication rate was found. Routine cardiac screening before commencing SET is not required. Our results may diminish perceived uncertainties regarding safety and will possibly increase the use of SET in daily practice.

Agreements and discrepancies between the estimated walking distance, nongraded and graded treadmill testing, and outside walking in patients with intermittent claudication.

BACKGROUND: Disease severity in patients with intermittent claudication (IC) is often assessed using walking distances and treadmill tests. The aim of this study was to determine the agreement between walking distance as estimated by the patient, as measured during outside walking, and as determined using a nongraded treadmill protocol (NGTP), and an incremental graded (Gardner-Skinner) treadmill protocol (GSP). METHODS: In this prospective observational study, 30 patients with IC estimated their maximal walking distance (MWD) and completed a "Walking Impairment Questionnaire" (WIQ). Outside walking was determined using a measuring wheel and a GSP controlled device. Primary outcomes were differences in MWD and variability (coefficient of variation, COV). Secondary outcomes were results of WIQ and differences in walking speed. RESULTS: Estimated walking distance was significantly higher than MWD as objectively measured during outside walking (400 m vs. 309 m, respectively, P = 0.02). A substantial variability (COV = 55%) was found between both parameters. A small 35-m MWD difference between outside walking and GSP was found with a substantial scatter (COV = 42%). In contrast, a much larger 122-m MWD difference was present between outside walking and NGTP (COV = 89%). Patients walked significantly faster in the open air than on treadmills (median outside walking speed = 3.8 km/hr, GSP = 3.2 km/hr, NGTP = 2.8 km/hr; P < 0.001). CONCLUSIONS: An incremental graded (Gardner-Skinner) treadmill protocol demonstrated the best agreement to outside walking. Discrepancies between treadmill tests and outside walking may be explained by a difference in walking speed. A single determination of a walking distance is a poor reflection of true walking capacity.

Modes of exercise training for intermittent claudication.

BACKGROUND: According to international guidelines and literature, all patients with intermittent claudication should receive an initial treatment of cardiovascular risk modification, lifestyle coaching, and supervised exercise therapy. In most studies, supervised exercise therapy consists of treadmill or track walking. However, alternative modes of exercise therapy have been described and yielded similar results to walking. Therefore, the following question remains: Which exercise mode gives the most beneficial results? PRIMARY OBJECTIVE: To assess the effects of different modes of supervised exercise therapy on the maximum walking distance (MWD) of patients with intermittent claudication. SECONDARY OBJECTIVES: To assess the effects of different modes of supervised exercise therapy on pain-free walking distance (PFWD) and health-related quality of life scores (HR-QoL) of patients with intermittent claudication. SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Cochrane Peripheral Vascular Diseases Group Specialised Register (July 2013); CENTRAL (2013, Issue 6), in The Cochrane Lib rary; and clinical trials databases. The authors searched the MEDLINE (1946 to July 2013) and Embase (1973 to July 2013) databases and reviewed the reference lists of identified articles to detect other relevant citations. SELECTION CRITERIA: Randomised controlled trials of studies comparing alternative modes of exercise training or combinations of exercise modes with a control group of supervised walking exercise in patients with clinically determined intermittent claudication. The supervised walking programme needed to be supervised at least twice a week for a consecutive six weeks of training. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, extracted data, and assessed the risk of bias for each study. Because of different treadmill test protocols to assess the maximum or pain-free walking distance, we converted all distances or walking times to total metabolic equivalents (METs) using the American College of Sports Medicine (ACSM) walking equation. MAIN RESULTS: In this review, we included a total of five studies comparing supervised walking exercise and alternative modes of exercise. The alternative modes of exercise therapy included cycling, strength training, and upper-arm ergometry. The studies represented a sample size of 135 participants with a low risk of bias. Overall, there was no clear evidence of a difference between supervised walking exercise and alternative modes of exercise in maximum walking distance (8.15 METs, 95% confidence interval (CI) -2.63 to 18.94, P = 0.14, equivalent of an increase of 173 metres, 95% CI -56 to 401) on a treadmill with no incline and an average speed of 3.2 km/h, which is comparable with walking in daily life.Similarly, there was no clear evidence of a difference between supervised walking exercise and alternative modes of exercise in pain-free walking distance (6.42 METs, 95% CI -1.52 to 14.36, P = 0.11, equivalent of an increase of 136 metres, 95% CI -32 to 304). Sensitivity analysis did not alter the results significantly. Quality of life measures showed significant improvements in both groups; however, because of skewed data and the very small sample size of the studies, we did not perform a meta-analysis for health-related quality of life and functional impairment. AUTHORS' CONCLUSIONS: There was no clear evidence of differences between supervised walking exercise and alternative exercise modes in improving the maximum and pain-free walking distance of patients with intermittent claudication. More studies with larger sample sizes are needed to make meaningful comparisons between each alternative exercise mode and the current standard of supervised treadmill walking. The results indicate that alternative exercise modes may be useful when supervised walking exercise is not an option for the patient.

Bicycle testing as an alternative diagnostic tool in patients suspected of intermittent claudication.

BACKGROUND: The ankle-brachial index (ABI) obtained after a treadmill challenge is often used to confirm the diagnosis of intermittent claudication (IC). However, some patients fail treadmill testing due to (temporary) orthopedic or neurologic comorbidity or fear of falling. The aim of this study was to evaluate the role of bicycle testing as an alternative for treadmill testing. It was hypothesized that ABIs obtained after bicycle tests were not different compared with values after standard treadmill testing. METHODS: In this validation study, newly diagnosed IC patients (Rutherford 1-3) underwent a standard treadmill test (TT, "gold standard") and two bicycle protocols, one with a continuous resistance submaximal character (submaximal bicycle test, SBT) and a second with an incremental ramp form having a maximal character (maximal bicycle test, MBT). ABIs of both legs were obtained before and twice after each of these three different exercise tests. Healthy individuals matched for age and gender served as controls. RESULTS: The study population consisted of 32 patients (68 ± 11 years, 21 men). ABIs of each leg (n = 64) obtained after TT correlated significantly with values obtained after either bicycle test (TT vs. SBT: r = 0.90, P < 0.001; TT vs. MBT: r = 0.88, P < 0.001). Drops in ABI after both types of exercise were significantly correlated (TT vs. SBT: r = 0.66, P < 0.001; TT vs. MBT: r = 0.32, P < 0.01). A 98% sensitivity and 86% specificity for diagnosis of IC was observed after the SBT. After the MBT, these values were 98% and 43%, respectively. Healthy controls (n = 13) demonstrated ABI values >0.9 after cycling in all tests. CONCLUSIONS: Both submaximal and a maximal bicycle tests may serve as alternative noninvasive tools for detecting intermittent claudication. Bicycle tests can potentially be used for patients unable to perform a treadmill test.

Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication.

BACKGROUND: Although supervised exercise therapy is considered to be of significant benefit for people with leg pain (peripheral arterial disease (PAD)), implementing supervised exercise programs (SETs) in daily practice has limitations. This is an update of a review first published in 2006. OBJECTIVES: The main objective of this review was to provide an accurate overview of studies evaluating the effects of supervised versus non-supervised exercise therapy on maximal walking time or distance on a treadmill for people with intermittent claudication. SEARCH METHODS: For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched September 2012) and CENTRAL (2012, Issue 9). In addition, we handsearched the reference lists of relevant articles for additional trials. No restriction was applied to language of publication. SELECTION CRITERIA: Randomized clinical trials comparing supervised exercise programs with non-supervised exercise programs (defined as walking advice or a structural home-based exercise program) for people with intermittent claudication. Studies with control groups, which did not receive exercise or walking advice or received usual care (maintained normal physical activity), were excluded. DATA COLLECTION AND ANALYSIS: Two review authors (HJPF and BLWB) independently selected trials and extracted data. Three review authors (HJPF, BLWB, and GJL) assessed trial quality, and this was confirmed by two other review authors (MHP and JAWT). For all continuous outcomes, we extracted the number of participants, the mean differences, and the standard deviation. The 36-Item Short Form Health Survey (SF-36) outcomes were extracted to assess quality of life. Effect sizes were calculated as the difference in treatment normalized with the standard deviation (standardized mean difference) using a fixed-effect model. MAIN RESULTS: A total of 14 studies involving a total of 1002 male and female participants with PAD were included in this review. Follow-up ranged from six weeks to 12 months. In general, supervised exercise regimens consisted of three exercise sessions per week. All trials used a treadmill walking test as one of the outcome measures. The overall quality of the included trials was moderate to good, although some trials were small with respect to the number of participants, ranging from 20 to 304.Supervised exercise therapy (SET) showed statistically significant improvement in maximal treadmill walking distance compared with non-supervised exercise therapy regimens, with an overall effect size of 0.69 (95% confidence interval (CI) 0.51 to 0.86) and 0.48 (95% CI 0.32 to 0.64) at three and six months, respectively. This translates to an increase in walking distance of approximately 180 meters that favored the supervised group. SET was still beneficial for maximal and pain-free walking distances at 12 months, but it did not have a significant effect on quality of life parameters. AUTHORS' CONCLUSIONS: SET has statistically significant benefit on treadmill walking distance (maximal and pain-free) compared with non-supervised regimens. However, the clinical relevance of this has not been demonstrated definitively; additional studies are required that focus on quality of life or other disease-specific functional outcomes, such as walking behavior, patient satisfaction, costs, and long-term follow-up. Professionals in the vascular field should make SET available for all patients with intermittent claudication.

Accuracy of the Precision Saw versus the Sagittal Saw during total knee arthroplasty: A randomised clinical trial.

BACKGROUND: The aim of this study was to compare the accuracy of the oscillating tip saw system (Precision Saw=PS) with the more conventional fully oscillating blade system (Sagittal Saw=SS) during computer-assisted total knee arthroplasty (CAS-TKA). METHODS: A prospective, randomised, controlled trial included 58 consecutive patients who underwent primary CAS-TKA and were randomly assigned in the PS group or the SS group to compare the accuracy of both blades. The primary outcome was the difference between the intended cutting planes and the actual cutting planes in degrees (°) in two planes of both the femur and the tibia. The secondary outcome was total surgery time. RESULTS: Tibia: In the VV-plane no significant differences were registered for the mean absolute deviation (p=0.28). The PS was more accurate in the AP-plane (p=0.03). Femur: The PS showed significantly fewer mean absolute deviations in the VV-plane (p=0.03); however, the SS revealed better accuracy in the FE-plane (p=0.04). The difference in the surgery time between the groups was not statistically significant (p=0.45). Two outliers were measured using the SS, while seven outliers were detected using the PS. CONCLUSION: The Precision Saw is not proven to be overall more accurate than the Sagittal Saw. Significantly better accuracy was shown with the PS in the two cutting planes, with the exception of one cutting plane that favoured the SS. Greater number of outliers were found using the PS. LEVEL OF EVIDENCE: II.