The role of exercise testing in predicting successful ambulation with a lower extremity prosthesis: a systematic literature review and clinical practice guideline

Background

Growing discontent with the k-level system for functional classification of patients with limb loss and movement of healthcare toward evidence-based practice has resulted in the need for alternative forms of functional classification and development of clinical practice guidelines to improve access to quality prosthetic interventions. The purpose of this project was to develop and present a clinical practice recommendation for exercise testing in prosthetic patient care based on the results and synthesis of a systematic literature review.

Methods

Database searches of PubMed, Google Scholar, Web of Science, and Cochrane were conducted and articles reviewed. Of the potential 1386 articles 10 met the criteria for inclusion. These articles were assessed using the critical appraisal tool of the United Kingdom National Service Framework for Long-Term Conditions. Of the 10 included articles eight were of high, one of medium, and one of low, quality. Data from these articles were synthesized into 6 empirical evidence statements, all qualifying for research grade A. These statements were used to develop the proposed clinical practice guideline.

Results

While the results of this systematic review were not able to support the direct connection between cardiorespiratory performance and K-levels, the literature did support the ability of exercise testing results to predict successful prosthetic ambulation in some demographics. Both continuous maximum-intensity single lower extremity ergometer propelled by a sound limb and intermittent submaximal upper extremity ergometer protocols were found to be viable evaluation tools of cardiorespiratory fitness and function in the target population.

Conclusion

The ability to sustain an exercise intensity of ≥50% of a predicted VO_2max value in single leg cycle ergometry testing and achievement of a sustained workload of 30 W in upper extremity ergometry testing were found to be the strongest correlates to successful ambulation with a prosthesis. VO₂ values were found to increase in amputee subjects following a 6-week exercise program. These synthesized results of the systematic literature review regarding exercise testing in patients with loss of a lower extremity were used to develop and a present a clinical treatment pathway.

     

A hybrid image fusion system for endovascular interventions of peripheral artery disease

Purpose

Interventional endovascular treatment has become the first line of management in the treatment of peripheral artery disease (PAD). However, contrast and radiation exposure continue to limit the feasibility of these procedures. This paper presents a novel hybrid image fusion system for endovascular intervention of PAD. We present two different roadmapping methods from intra- and pre-interventional imaging that can be used either simultaneously or independently, constituting the navigation system.

Methods

The navigation system is decomposed into several steps that can be entirely integrated within the procedure workflow without modifying it to benefit from the roadmapping. First, a 2D panorama of the entire peripheral artery system is automatically created based on a sequence of stepping fluoroscopic images acquired during the intra-interventional diagnosis phase. During the interventional phase, the live image can be synchronized on the panorama to form the basis of the image fusion system. Two types of augmented information are then integrated. First, an angiography panorama is proposed to avoid contrast media re-injection. Information exploiting the pre-interventional computed tomography angiography (CTA) is also brought to the surgeon by means of semiautomatic 3D/2D registration on the 2D panorama. Each step of the workflow was independently validated.

Results

Experiments for both the 2D panorama creation and the synchronization processes showed very accurate results (errors of 1.24 and \(2.6 \pm 1.4\) mm, respectively), similarly to the registration on the 3D CTA (errors of \(1.5 \pm 0.7\) mm), with minimal user interaction and very low computation time. First results of an on-going clinical study highlighted its major clinical added value on intraoperative parameters.

Conclusion

No image fusion system has been proposed yet for endovascular procedures of PAD in lower extremities. More globally, such a navigation system, combining image fusion from different 2D and 3D image sources, is novel in the field of endovascular procedures.

     

3D–2D registration in endovascular image-guided surgery: evaluation of state-of-the-art methods on cerebral angiograms

Purpose

Image guidance for minimally invasive surgery is based on spatial co-registration and fusion of 3D pre-interventional images and treatment plans with the 2D live intra-interventional images. The spatial co-registration or 3D–2D registration is the key enabling technology; however, the performance of state-of-the-art automated methods is rather unclear as they have not been assessed under the same test conditions. Herein we perform a quantitative and comparative evaluation of ten state-of-the-art methods for 3D–2D registration on a public dataset of clinical angiograms.

Methods

Image database consisted of 3D and 2D angiograms of 25 patients undergoing treatment for cerebral aneurysms or arteriovenous malformations. On each of the datasets, highly accurate “gold-standard” registrations of 3D and 2D images were established based on patient-attached fiducial markers. The database was used to rigorously evaluate ten state-of-the-art 3D–2D registration methods, namely two intensity-, two gradient-, three feature-based and three hybrid methods, both for registration of 3D pre-interventional image to monoplane or biplane 2D images.

Results

Intensity-based methods were most accurate in all tests (0.3 mm). One of the hybrid methods was most robust with 98.75% of successful registrations (SR) and capture range of 18 mm for registrations of 3D to biplane 2D angiograms. In general, registration accuracy was similar whether registration of 3D image was performed onto mono- or biplanar 2D images; however, the SR was substantially lower in case of 3D to monoplane 2D registration. Two feature-based and two hybrid methods had clinically feasible execution times in the order of a second.

Conclusions

Performance of methods seems to fall below expectations in terms of robustness in case of registration of 3D to monoplane 2D images, while translation into clinical image guidance systems seems readily feasible for methods that perform registration of the 3D pre-interventional image onto biplanar intra-interventional 2D images.

     

VCSim3: a VR simulator for cardiovascular interventions

Purpose

Effective and safe performance of cardiovascular interventions requires excellent catheter/guidewire manipulation skills. These skills are currently mainly gained through an apprenticeship on real patients, which may not be safe or cost-effective. Computer simulation offers an alternative for core skills training. However, replicating the physical behaviour of real instruments navigated through blood vessels is a challenging task.

Methods

We have developed VCSim3—a virtual reality simulator for cardiovascular interventions. The simulator leverages an inextensible Cosserat rod to model virtual catheters and guidewires. Their mechanical properties were optimized with respect to their real counterparts scanned in a silicone phantom using X-ray CT imaging. The instruments are manipulated via a VSP haptic device. Supporting solutions such as fluoroscopic visualization, contrast flow propagation, cardiac motion, balloon inflation, and stent deployment, enable performing a complete angioplasty procedure.

Results

We present detailed results of simulation accuracy of the virtual instruments, along with their computational performance. In addition, the results of a preliminary face and content validation study conveyed on a group of 17 interventional radiologists are given.

Conclusions

VR simulation of cardiovascular procedure can contribute to surgical training and improve the educational experience without putting patients at risk, raising ethical issues or requiring expensive animal or cadaver facilities. VCSim3 is still a prototype, yet the initial results indicate that it provides promising foundations for further development.

     

Tomosynthesis implementation with adaptive online calibration on clinical C-arm systems

Purpose

Cone beam computed tomography (CBCT) systems offer physicians crucial 3D and 2D imaging capabilities during interventions. However, certain medical applications only require very specific information from the CBCTs (e.g., determination of the position of high-contrast objects). In diagnostics, tomosynthesis techniques can be used in these cases to minimize dose exposure. Therefore, integrating such techniques on CBCT systems could also be beneficial for interventions. In this paper, we investigate the performance of our implementation of circular tomosynthesis on a CBCT device.

Methods

The tomosynthesis scan trajectory is realized with step-and-shoot on a clinical C-arm device. The online calibration algorithm uses conventionally acquired 3D CBCT of the scanned object as prior knowledge to correct the imaging geometries. The online calibration algorithm was compared to an offline calibration to test its performance. A ball bearing phantom was used to evaluate the reconstructions with respect to geometric distortions. The evaluation was done for three different scenarios to test the robustness of our tomosynthesis implementation against object deviations (e.g., pen) and different object positioning.

Results

The circular tomosynthesis was tested on a ball bearing and an anthropomorphic phantom. The results show that the calibration is robust against isocenter shifts and object deviations in the CBCT. All reconstructions used 100 projections and displayed limited angle artifacts. The accuracy of the positions and shapes of high-contrast objects were, however, determined precisely. (The maximal center position deviation is 0.31 mm.)

Conclusion

For medical procedures that primarily determine the precise position of high-contrast objects, circular tomosynthesis could offer an approach to reduce dose exposure.

     

A virtual pointer to support the adoption of professional vision in laparoscopic training

Purpose

To assess a virtual pointer in supporting surgical trainees’ development of professional vision in laparoscopic surgery.

Methods

We developed a virtual pointing and telestration system utilizing the Microsoft Kinect movement sensor as an overlay for any imagine system. Training with the application was compared to a standard condition, i.e., verbal instruction with un-mediated gestures, in a laparoscopic training environment. Seven trainees performed four simulated laparoscopic tasks guided by an experienced surgeon as the trainer. Trainee performance was subjectively assessed by the trainee and trainer, and objectively measured by number of errors, time to task completion, and economy of movement.

Results

No significant differences in errors and time to task completion were obtained between virtual pointer and standard conditions. Economy of movement in the non-dominant hand was significantly improved when using virtual pointer (\(p = 0.012\)). The trainers perceived a significant improvement in trainee performance in virtual pointer condition (\(p < 0.001\)), while the trainees perceived no difference. The trainers’ perception of economy of movement was similar between the two conditions in the initial three runs and became significantly improved in virtual pointer condition in the fourth run (\(p = 0.017\)).

Conclusions

Results show that the virtual pointer system improves the trainer’s perception of trainee’s performance and this is reflected in the objective performance measures in the third and fourth training runs. The benefit of a virtual pointing and telestration system may be perceived by the trainers early on in training, but this is not evident in objective trainee performance until further mastery has been attained. In addition, the performance improvement of economy of motion specifically shows that the virtual pointer improves the adoption of professional vision— improved ability to see and use laparoscopic video results in more direct instrument movement.

     

The impact of test loads on the accuracy of 1RM prediction using the load-velocity relationship

Background

Numerous methods have been proposed that use submaximal loads to predict one repetition maximum (1RM). One common method applies standard linear regression equations to load and average vertical lifting velocity (V_mean) data developed during squat jumps or three bench press throw (BP-T). The main aim of this project was to determine which combination of three submaximal loads during BP-T result in the most accurate prediction of 1RM Smith Machine bench press strength in healthy individuals.

Methods

In this study combinations of three BP-T loads were used to predict 1RM Smith Machine bench press strength. Additionally, we examined whether regression models developed using peak vertical bar velocity (V_peak), rather than V_mean, provide the most accurate prediction of Smith Machine bench press 1RM. 1RM Smith Machine bench press strength was measured directly in 12 healthy regular weight trainers (body mass?=?80.8?±?5.7 kg). Two to three days later a linear position transducer attached to the collars on a Smith Machine was used to record V_mean and V_peak during BP-T between 30 and 70% of 1RM (10% increments).

Results

Repeated measures analysis of variance testing showed that the mean values for slope and ordinate intercept for the regression models at each of the load ranges differed significantly depending on whether V_mean or V_peak were used in the prediction models (P?<?0.001). Conversely, the abscissa intercept did not differ significantly between either measure of vertical bar velocity at each load range. The key finding in this study was that 1RM Smith Machine bench press strength can be determined with high relative accuracy by examining V_mean and V_peak during BP-T over three loads, with the most precise models using V_peak during loads representing 30, 40 and 50% of 1RM (R ² ?=?0.96, SSE?=?4.2 kg).

Conclusions

These preliminary findings indicate that exercise programmers working with normal healthy populations can accurately predict Smith Machine 1RM bench press strength using relatively light load Smith Machine BP-T testing, avoiding the need to expose their clients to potentially injurious loads.

     

Swimming induced pulmonary oedema in athletes – a systematic review and best evidence synthesis

Background

Swimming induced pulmonary oedema is an uncommon occurrence and usually presents during strenuous distance swimming in cold water. The prevalence is most likely underreported and the underlying mechanisms are controversial. The purpose of this study was to summarize the evidence with regards to prevalence, pathophysiology and treatment of swimming induced pulmonary oedema in endurance athletes.

Methods

Medline, Embase, Scopus and Google Scholar were searched and level I-IV from 1970 to 2017 were included. For clinical studies, only publications reporting on swimming-induced pulmonary oedema were considered. Risk of bias was assessed with the ROBINS-I tool, and the quality of evidence was assessed with the Cochrane GRADE system. For data synthesis and analysis, a best evidence synthesis was used.

Results

A total of 29 studies were included (174 athletes). The most common symptom was cough, dyspnoea, froth and haemoptysis. The risk of bias for the clinical studies included 13 with moderate risk, 3 with serious, and 4 with critical. Four of the pathophysiology studies had a moderate risk, 3 a serious risk, and 1 a critical risk of bias. A best evidence analysis demonstrated a strong association between cold water immersion and in increases of CVP (central venous pressure), MPAP (mean pulmonary arterial pressure), PVR (peripheral vascular resistance) and PAWP (pulmonary arterial wedge pressure) resulting in interstitial asymptomatic oedema.

Conclusion

The results of this study suggest a moderate association between water temperature and the prevalence of SIPE. The presence of the clinical symptoms cough, dyspnoea, froth and haemoptysis are strongly suggestive of SIPE during or immediately following swimming. There is only limited evidence to suggest that there are pre-existing risk factors leading to SIPE with exposure to strenuous physical activity during swimming. There is strong evidence that sudden deaths of triathletes are often associated with cardiac abnormalities.

     

Effects of high intensity interval training on exercise capacity in people with cystic fibrosis: study protocol for a randomised controlled trial

Background

In people with cystic fibrosis (CF), higher exercise capacity is associated with better health-related quality of life (HRQoL), reduced risk of hospitalisation for a respiratory infection and survival. Therefore, optimisation of exercise capacity is an important treatment goal. The Australian and New Zealand clinical practice guidelines recommend that people with CF complete 30 to 60 min of moderate intensity aerobic exercise on most days of the week. This recommendation can be difficult to achieve by people with CF because of time constraints, and intolerable breathlessness and muscle fatigue during continuous exercise. In contrast, a low-volume, high intensity interval training (HIIT) program may be a more achievable and efficient training method to improve exercise capacity in people with CF.

Methods

A randomised controlled trial will be undertaken. Forty people with CF (aged ≥15 years) will be randomly allocated, on a 1:1 ratio, to either the experimental or control group. Regardless of their group allocation, all participants will be asked to continue with their usual daily treatment for the study duration. Those in the experimental group will complete 8 weeks of thrice weekly HIIT on a cycle ergometer. Those in the control group will receive weekly contact with the investigators. The primary outcome of this study is exercise capacity. Secondary outcomes are HRQoL, exercise self-efficacy, feelings of anxiety, depression and enjoyment. These outcomes will be recorded at baseline (i.e. prior to randomisation) and following the 8-week intervention period. The study will also report other outcomes of the HIIT program (cardiovascular responses, symptom response, post-exercise muscle soreness and tolerance) and behaviour change techniques such as reinforcement, feedback and goal setting, used during the HIIT program.

Discussion

This study will determine the effects of 8-weeks of supervised, low-volume HIIT, completed on a cycle ergometer on measures of exercise capacity, HRQoL, exercise self-efficacy, feelings of anxiety, depression and enjoyment. If effective, this type of training could be an attractive alternative to traditional continuous training because it may be more achievable and time efficient.

Trial registration

Australian and New Zealand Clinical Trials Registry (ANZCTR):12617001271392 (04/09/2017).

     

Psychometric properties of the Zephyr bioharness device: a systematic review

Background

Technological development and improvements in Wearable Physiological Monitoring devices, have facilitated the wireless and continuous field-based monitoring/capturing of physiologic measures in healthy, clinical or athletic populations. These devices have many applications for prevention and rehabilitation of musculoskeletal disorders, assuming reliable and valid data is collected. The purpose of this study was to appraise the quality and synthesize findings from published studies on psychometric properties of heart rate measurements taken with the Zephyr Bioharness device.

Methods

We searched the Embase, Medline, PsycInfo, PuMed and Google Scholar databases to identify articles. Articles were appraised for quality using a structured clinical measurement specific appraisal tool. Two raters evaluated the quality and conducted data extraction. We extracted data on the reliability (intra-class correlation coefficients and standard error of measurement) and validity measures (Pearson/Spearman’s correlation coefficients) along with mean differences. Agreement parameters were summarised by the average biases and 95% limits of agreement.

Results

A total of ten studies were included: quality ratings ranged from 54 to 92%. The intra-class correlation coefficients reported ranged from 0.85–0.98. The construct validity coefficients compared against gold standard calibrations or other commercially used devices, ranged from 0.74–0.99 and 0.67–0.98 respectively. Zephyr Bioharness agreement error ranged from ??4.81 (under-estimation) to 3.00 (over-estimation) beats per minute, with varying 95% limits of agreement, when compared with gold standard measures.

Conclusion

Good to excellent quality evidence from ten studies suggested that the Zephyr Bioharness device can provide reliable and valid measurements of heart rate across multiple contexts, and that it displayed good agreements vs. gold standard comparators – supporting criterion validity.