scholarly journals Feasibility study to evaluate cycloidal vibration therapy for the symptomatic treatment of intermittent claudication

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Leanne Atkin ◽  
John Stephenson ◽  
Karen Ousey
Keyword(s):  
Intermittent Claudication ◽  
Feasibility Study ◽  
Treatment Phase ◽  
Randomised Control Trial ◽  
Essential Information ◽  
Vibration Therapy ◽  
Supervised Exercise ◽  
Walking Time ◽  
Leg Pressure

Abstract Introduction Intermittent claudication (IC) is the most common symptom of peripheral arterial disease. Previous research has suggested that cycloidal vibration therapy (CVT) may induce angiogenesis and improvements in circulation. The objective of this feasibility study was to explore trial design and acceptability of the protocol to provide data to estimate the parameters required to design a definitive randomised control trial. This feasibility study specifically aimed to assess recruitment rate; attendance rates at baseline and follow-up; and safety, tolerability, and compliance with therapy device and additionally, to consider the potential efficacy of CVT as a novel treatment for intermittent claudication. Methods Patients with intermittent claudication (IC) were recruited and CVT was applied at home for 30 min twice a day for a period of 12 weeks. Primary outcomes were pain-free walking time (PFWT) and maximum walking time (MWT) after 12 weeks of treatment. Secondary outcomes included the ankle-brachial index and ankle systolic blood pressure. Participants were assessed during active therapy phase at baseline, week 4, week 8, and week 12. Results Thirty-four participants with IC were recruited: 30 (88%) male and 4 (12%) female. The rate of recruitment was 2.4 participants per month from a standard-size district general hospital. No participants left the study during the activity therapy stage, and no participant failed to attend their follow-up appointment. The general compliance with CVT was high. No participants dropped out during the treatment phase. The mean age of all participants was 68 years (IQR 60–75 years). Substantive improvements were seen in a comparison of differences in times to PFWT and MWT, in ABPI, and in systolic leg pressure in the treated leg. There was no evidence of a substantive difference from baseline in systolic leg pressure in the untreated leg. There were no immediate or delated treatment safety concerns of documented adverse effects with the treatment, all patients completed the required 12-week course indicated a high degree of patient acceptability. Conclusion The statistically significant and substantive improvements from baseline after 12 weeks observed in PFWT and MWT in participants experiencing IC are comparable to improvements seen from other treatment options such as supervised exercise as reported by Stewart et al. (N Engl J Med 347:1941–1951, 2002). The substantive improvement in systolic leg pressure in the treated leg and the concurrent absence of a substantive change in systolic leg pressure in the untreated leg over the same period suggests a causative effect. This study has provided novel information relating to the number of potential eligible participants for a further research trial and potential association between CVT and improved symptoms. Additionally, it has established that CVT treatment is highly acceptable, as indicated by no participant drop-out in the treatment phase, and may potentially offer an alternative treatment option for patients experiencing IC. Furthermore, this study has assessed the variability of the primary outcome measure which provides vital information needed to calculate sample sizes for any future studies. In conclusion, this study has established the feasibility of using CVT to improve patients’ symptoms of IC and provides essential information which will contribute to the design of future research investigating whether the improvements seen are directly related to CVT.

HRT preserves increases in bone mineral density and reductions in body fat after a supervised exercise program

1998 ◽  
Vol 84 (5) ◽  
pp. 1506-1512 ◽  
Author(s):  
Wendy M. Kohrt ◽  
Ali A. Ehsani ◽  
Stanley J. Birge
Keyword(s):  
Bone Mineral Density ◽  
Lumbar Spine ◽  
Bone Mineral ◽  
Exercise Program ◽  
Treatment Phase ◽  
Mineral Density ◽  
Supervised Exercise ◽  
Total Body ◽  
Exercise Induced

The aims of this study were to confirm our previous finding that hormone-replacement therapy (HRT) augments exercise-induced increases in bone mineral density (BMD) in older women and to determine whether HRT preserves the adaptations when exercise is reduced or discontinued. The study included an 11-mo treatment phase and a 6-mo follow-up phase. Participants, aged 66 ± 3 yr, were assigned to control (Con; n = 10), exercise (Ex; n = 18), HRT ( n = 10), and Ex+HRT ( n = 16) groups. HRT was continued during the follow-up. After the treatment phase, changes in total body BMD were −0.5 ± 1.7, 1.5 ± 1.4, 1.2 ± 0.8, and 2.7 ± 1.2% in Con, Ex, HRT, and Ex+HRT, respectively. Ex+HRT was more effective than HRT in increasing BMD of the total body and tended ( P = 0.08) to be more effective at the lumbar spine. Ex+HRT was more effective than Ex in increasing BMD of the total body, lumbar spine, and trochanter. Exercise-induced gains in BMD were preserved during the follow-up only in those individuals on HRT. HRT also attenuated fat accumulation, particularly in the abdominal region, after the exercise program. These findings suggest that HRT is an important adjunct to exercise for the prevention not only of osteoporosis but also of diseases related to abdominal obesity.

scholarly journals 1031 A Mixed Methods Feasibility Study of Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
L Hitchman ◽  
J Totty ◽  
R Lathan ◽  
M Sidapra ◽  
G Smith ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mixed Methods ◽  
Feasibility Study ◽  
Randomised Control Trial ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Patient Reported ◽  
The Mean

Abstract Aim The purpose of this mixed methods feasibility study was to assess the feasibility of delivering ESWT to patients with DFUs. It also aimed to explore any potential clinical effect of ESWT on wound healing and investigate whether ESWT may offer any patient reported benefits. Method A single centre mixed methods feasibility study. Patients with a DFU who met the eligibility criteria underwent ESWT 3 times in over 7 days. Primary outcome was feasibility of delivering the intervention. Secondary outcomes included wound size, number of DFU healed at 12 weeks and quality of life. Semi-structured interviews explored participants experience of undergoing ESWT. Results 22.6% (24/106) of patients screened were recruited. The mean attendance to clinic was 90.9% and 65.1% to follow up. The mean score for acceptability and tolerability was 9.86 (SD 0.48, 95% CI 9.62-10.01) and 9.15 (SD 2.57, 95% CI 7.87-10.42) respectively. There were no serious adverse events or side effects. 45.5% of DFU healed during follow up and quality of life scores improved until 8 weeks. Key themes identified from the qualitative interviews were desire for the fast healing, improved quality of life, new treatments must be flexible and accessible on transport. Conclusions This study has shown it is possible to recruit and retain patents into this research. This study supports development of a large randomised control trial to determine the clinical and cost effectiveness of ESWT for DFU healing.

Long-term effects of supervised exercise training on walking capacity and quality of life in patients with intermittent claudication

VASA ◽  
2008 ◽  
Vol 37 (3) ◽  
pp. 250-256 ◽  
Author(s):  
Keo ◽  
Grob ◽  
Guggisberg ◽  
Widmer ◽  
Baumgartner ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Exercise Training ◽  
Intermittent Claudication ◽  
Long Term Effects ◽  
Supervised Exercise ◽  
Exercise Training Program ◽  
Walking Capacity

Supervised exercise training has been shown to improve walking capacity in several studies of patients with intermittent claudication. However, data on long-term outcome are quite limited. The aim of this prospective study was to evaluate long-term effects of supervised exercise training on walking capacity and quality of life in patients with intermittent claudication. Patients and methods: Sixty-seven consecutive patients with intermittent claudication who completed a supervised 12-week exercise training program were asked for follow up evaluation 39 ± 20 months after program completion. Pain-free walking distance (PWD) and maximum walking distances (MWD) were assessed by treadmill test and several questionnaires. Results: Forty (60%) patients agreed to participate, 22 (33%) refused participation, and 5 (7%) died during follow-up. PWD and MWD significantly improved at completion of 12-weeks supervised exercise training as compared to baseline (PWD 114 ± 100 vs. 235 ± 248, p = 0.002; MWD 297 ± 273 vs. 474 ± 359, p = 0.001). Improvement of PWD and MWD could be maintained at follow up (197 ± 254, p = 0.014; 390 ± 324, p = 0.035, respectively) with non-smokers showing significantly better sustained PWD and MWD improvement as compared to baseline. Overall, walking capacity correlated with functional status of quality of life. Conclusions: Major findings of this investigation were that improvement in walking capacity is sustained after completion of supervised exercise training program with best results in patients who quitted or never smoked. Improved walking capacity is associated with increased functional status of quality of life.

scholarly journals Effect of diabetes mellitus on walking distance parameters after supervised exercise therapy for intermittent claudication: A systematic review

2016 ◽  
Vol 22 (1) ◽  
pp. 21-27 ◽  
Author(s):  
David Hageman ◽  
Lindy NM Gommans ◽  
Marc RM Scheltinga ◽  
Joep AW Teijink
Keyword(s):  
Diabetes Mellitus ◽  
Systematic Review ◽  
Intermittent Claudication ◽  
Exercise Therapy ◽  
Walking Distance ◽  
Inclusion Criteria ◽  
Potential Influence ◽  
Supervised Exercise ◽  
Exercise Response

Some believe that certain patients with intermittent claudication may be unsuitable for supervised exercise therapy (SET), based on the presence of comorbidities and the possibly increased risks. We conducted a systematic review (MEDLINE, EMBASE and CENTRAL) to summarize evidence on the potential influence of diabetes mellitus (DM) on the response to SET. Randomized and nonrandomized studies that investigated the effect of DM on walking distance after SET in patients with IC were included. Considered outcome measures were maximal, pain-free and functional walking distance (MWD, PFWD and FWD). Three articles met the inclusion criteria ( n = 845). In one study, MWD was 111 meters (128%) longer in the non-DM group compared to the DM group after 3 months of follow-up ( p = 0.056). In a second study, the non-DM group demonstrated a significant increase in PFWD (114 meters, p ⩽ 0.05) after 3 months of follow-up, whereas there was no statistically significant increase for the DM group (54 meters). On the contrary, the largest study of this review did not demonstrate any adverse effect of DM on MWD and FWD after SET. In conclusion, the data evaluating the effects of DM on SET were inadequate to determine if DM impairs the exercise response. While trends in the data do not suggest an impairment, they are not conclusive. Practitioners should consider this limitation when making clinical decisions.

scholarly journals Supervised exercise therapy and revascularization: Single-center experience of intermittent claudication management

2019 ◽  
Vol 24 (3) ◽  
pp. 208-215 ◽  
Author(s):  
Elke Bouwens ◽  
Sanne Klaphake ◽  
Karin J Weststrate ◽  
Joep AW Teijink ◽  
Hence JM Verhagen ◽  
...  
Keyword(s):  
Intermittent Claudication ◽  
Exercise Therapy ◽  
Walking Distance ◽  
Line Treatment ◽  
Single Center ◽  
First Line ◽  
Additional Intervention ◽  
Supervised Exercise ◽  
First Line Treatment

Guidelines recommend supervised exercise therapy (SET) as first-line treatment for intermittent claudication. However, the use of revascularization is widespread. We addressed the effectiveness of preventing (additional) invasive revascularization after primary SET or revascularization based on lesion and patient characteristics. In this single-center, retrospective, cohort study, 474 patients with intermittent claudication were included. Patients with occlusive disease of the aortoiliac tract and/or common femoral artery (inflow) were primarily considered for revascularization, while patients with more distal disease (outflow) were primarily considered for SET. In total, 232 patients were referred for SET and 242 patients received revascularization. The primary outcome was freedom from (additional) intervention, analyzed by Kaplan–Meier estimates. Secondary outcomes were survival, critical ischemia, freedom from target lesion revascularization (TLR), and an increase in maximum walking distance. In the SET-first strategy, 71% of patients had significant outflow lesions. Freedom from intervention was 0.90 ± 0.02 at 1-year and 0.82 ± 0.03 at 2-year follow-up. In the primary revascularization group, 90% of patients had inflow lesions. Freedom from additional intervention was 0.78 ± 0.03 at 1-year and only 0.65 ± 0.04 at 2-year follow-up, despite freedom from TLR of 0.91 ± 0.02 and 0.85 ± 0.03 at 1- and 2-year follow-up, respectively. In conclusion, SET was effective in preventing invasive treatment for patients with mainly outflow lesions. In contrast, secondary intervention rates following our strategy of primary revascularization for inflow lesions were unexpectedly high. These findings further support the guideline recommendations of SET as first-line treatment for all patients with intermittent claudication irrespective of level of disease.

P4700Work during treadmill rehabilitation predicts clinical benefit and muscle mitochondrial improvements in intermittent claudication

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Murrow ◽  
J Brizendine ◽  
B Djire ◽  
H Young ◽  
S Rathbun ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Blood Flow ◽  
Training Program ◽  
Intermittent Claudication ◽  
Training Period ◽  
Supervised Exercise ◽  
Work Level ◽  
The Impact ◽  
Walking Time ◽  
Mitochondrial Capacity

Abstract Background Supervised exercise training is recommended for intermittent claudication in peripheral artery disease (PAD), but the relationship between work achieved during exercise and clinical outcomes is not well described. As in other training modalities, increased effort measured by cumulative work production is expected to be translate into to positive performance adaptations. In settings of constrained limb blood flow, this relationship is unknown. In addition, the impact of exercise on skeletal muscle oxygen use capacity changes is unknown. Near infrared spectroscopy (NIRS) offers a method of characterizing skeletal muscle mitochondrial adaptations before and after training programs. Methods We enrolled subjects (n=17, age 71±8.8 years, 20% female) with PAD and intermittent claudication (ankle brachial index [ABI]=0.76±0.21) in a 12-week supervised training program, randomized to traditional pain-based training strategy versus hypoxia-based training (using NIRS to direct training). Muscle work was calculated based on training performance. NIRS-based determination of mitochondrial capacity and microvascular flow were measured at baseline and after 12 weeks. Results Subjects trained for an average of 32.9±5.9 sessions walking at 54.4±13.4 m/min per session. Subjects achieved a mean of average workload of 4767±5112 kilogram force meter (kpm) per session and an aggregate of 148536±148020 kpm for the training program. Baseline pain-free walking time of 2.95±2.10 minutes increased by a mean of 3.74±2.47 minutes. Increase in walking time was proportional to the average work level achieved per session, with a correlating trend to the overall work level performed over 12 weeks (r=0.543, p=0.024). There was no increase in blood flow measured by ABI or limb microcirculation perfusion index over the training period. Skeletal muscle mitochondrial capacity increased over the training period and correlated with the overall work performed (r=0.573, p=0.016). Figure 1 Conclusions Treadmill exercise rehabilitation for intermittent claudication may be guided by total dose of exercise and NIRS-based indices of mitochondrial capacity rather than pain-levels achieved or changes in perfusion measures. Acknowledgement/Funding American Heart Association

scholarly journals Research Study Protocol: Using health information systems to address patients concerns in general practice: the COAC Intervention development and feasibility study

2021 ◽  
Author(s):  
Mairead Murphy ◽  
Chris Salisbury ◽  
Tom Palmer ◽  
Geoff Wong ◽  
Jude Hancock ◽  
...  
Keyword(s):  
General Practice ◽  
Feasibility Study ◽  
Complex Intervention ◽  
Online Survey ◽  
Health Knowledge ◽  
Well Being ◽  
Randomised Control Trial ◽  
Programme Theory ◽  
Patient Reported

Abstract BackgroundProblems are missed in up to 50% of primary care consultations. This is costly for the NHS, both in terms of reconsultation rates and in missed opportunities to increase patient empowerment. Research suggests that interventions at each end of the consultation can help to address patient concerns. At consultation initiation, sharing the results from electronic patient-reported outcome measures (ePROMs) with clinicians can help to elicit concerns. At consultation closure, providing the patient with written information to supplement spoken can improve recall and adherence.Aims and ObjectivesAim: To develop and test a complex intervention designed to more comprehensively address patients’ concerns in general practice, thereby reducing re-consultation rates, improving patients’ well-being and health knowledge, reducing health concerns and increasing patients’ confidence in their health provision and health plan. The aims will be achieved through two studies. Firstly a complex intervention will be designed, which uses an ePROM at consultation opening and a report printed or texted at consultation closure. Secondly, this intervention will be tested to establish the feasibility both of the intervention and of a randomised control trial (RCT) of the intervention.Methods1. Intervention Design Study: This will involve:1. Design of an online questionnaire system using practice SMS/email systems and online survey software to allow patient self-completion of a pre-consultation questionnaire and a report showing low-scoring questionnaire items, which is shared with GPs or nurses.2. Testing the pre-consultation system with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient, administrator, receptionist, nurse and GP feedback after each round.3. Design of an electronic template, integrated with the patient record, to provide a printable consultation-closure report to patients on issues raised in the consultation, advice given, treatment, follow-up and safety-netting.4. Testing the consultation-closure report iteratively with 45 patients in 3 rounds, using a person-based approach, with iterative adjustments made based on patient and GP/nurse feedback after each round.2. Feasibility Study: The intervention will be tested in a cluster-randomised framework as follows:1. Refinement of the intervention and update to programme theory.2. Randomisation of six practices: four randomised to intervention, and two to control.3. Recruitment of 30 patients per practice: 120 intervention and 60 control.4. Data Collection of quantitative data via GP/nurse-report, patient-report and health records. Interview of GPs, nurses, practice manager, administrators and receptionists and up to 30 patients.5. Realist evaluation of the data to identify and understand the mechanisms by which outcomes have occurred within the programme theory.6. Data analysis of recruitment rates, follow-up rates, data completeness, re-consultation rates within one/three months and other outcomes measures to assess feasibility of a future RCT.7. Evaluation of pre-agreed success criteria to decide whether to continue to RCT, stop, or modify the intervention.Timelines for deliveryStudy 1 will be completed from October 2019 – March 2021 and study 2 from April 2021 – April 2022.Anticipated impact and disseminationResults will be disseminated through targeted communications in social media, the University of Bristol website, policy briefings, academic papers, patient participation groups, community associations and seminars and conferences. The study output resources will be made available for immediate use. If progression criteria are met, we will aim to complete a randomised control trial within five years.

Abstract 19720: Jay D. Coffman Early Career Investigator Award: Comparative Efficacy of Initial Endovascular Revascularization vs. Supervised Exercise Training in Patients With Intermittent Claudication: A Meta-analysis of Randomized Controlled Trials

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Ambarish Pandey ◽  
Subhash Banerjee ◽  
Christian Ngo ◽  
Purav Mody ◽  
Steven Marso ◽  
...  
Keyword(s):  
Exercise Training ◽  
Randomized Controlled Trials ◽  
Intermittent Claudication ◽  
Meta Analysis ◽  
Walking Distance ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Supervised Exercise ◽  
Endovascular Revascularization

Introduction: Current guidelines recommend supervised exercise training (SET) as the initial treatment modality for patients with intermittent claudication (IC), in addition to optimal medical therapy. The role of endovascular revascularization (ER) as a primary treatment option has been controversial. We performed a meta-analysis to compare the efficacy of initial ER vs. initial SET in patients with IC using data from randomized controlled trials. Methods: The primary outcome was treadmill-measured maximum walking distance (MWD) at the end of follow-up. Secondary outcomes included resting ankle brachial index (ABI) and treadmill-measured ischemic claudication distance (ICD) on follow-up. Risk of adverse limb events (revascularization, amputations) was also compared between the two groups. Random effects models were used for all analyses. Results: We included 1,145 patients from nine trials with a mean follow up duration of 13.7 months (42% aortoiliac lesions; 35% stent use; mean baseline ABI 0.64 vs. 0.67 for ER vs. SET). Follow-up MWD was not significantly different between patients undergoing ER vs. SET [Weighted mean difference (WMD) (95% CI): 19.1 m (-79.6 to 117.8 m); publication bias p=0.86]. Metaregression did not identify significant differences based on stent use or presence of aortoiliac disease. ICD was also similar between the two groups [WMD (95% CI): 36.1 m (-99.4 to 171.5 m)]. In contrast, patients undergoing ER had higher resting ABI on follow-up [WMD (95% CI): 0.14 (0.11 to 0.17), p<0.0001]. Adverse limb event rates were similar [5.4% vs. 8.2%, p=0.21]. Conclusion: Compared with initial SET, initial ER significantly improves resting ABI values. Although longer walking distance and lower rates of adverse limb events also appeared favorable for ER, these differences were not statistically significant in these intermediate term studies. Longer-term studies and those incorporating contemporary revascularization techniques are necessary.

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