scholarly journals Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e032146 ◽  
Author(s):  
Farhad Rezvani ◽  
Dirk Heider ◽  
Martin Härter ◽  
Hans-Helmut König ◽  
Frank Bienert ◽  
...  

IntroductionPeripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD.Methods and analysisThe investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months.Ethics and disseminationEthical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

2018 ◽  
Vol 23 (4) ◽  
pp. 349-357 ◽  
Author(s):  
Andrew W Gardner ◽  
Polly S Montgomery ◽  
Ming Wang

We estimated minimal clinically important differences (MCIDs) for small, moderate, and large changes in measures obtained from a standardized treadmill test, a 6-minute walk test, and patient-based outcomes following supervised and home-based exercise programs in symptomatic patients with peripheral artery disease (PAD). Patients were randomized to either 12 weeks of a supervised exercise program ( n=60), a home-based exercise program ( n=60), or an attention-control group ( n=60). Using the distribution-based method to determine MCIDs, the MCIDs for small, moderate, and large changes in peak walking time (PWT) in the supervised exercise group were 38, 95, and 152 seconds, respectively, and the changes in claudication onset time (COT) were 35, 87, and 138 seconds. Similar MCID scores were noted for the home-based exercise group. An anchor-based method to determine MCIDs yielded similar patterns of small, moderate, and large change scores in PWT and COT, but values were 1–2 minutes longer than the distribution approach. In conclusion, 3 months of supervised and home-based exercise programs for symptomatic patients with PAD results in distribution-based MCID small, moderate, and large changes ranging from 0.5 and 2.5 minutes for PWT and COT. An anchor-based approach yields higher MCID values, ranging from a minimum of 73 seconds for COT to a maximum of 4 minutes for PWT. The clinical implication is that a goal for eliciting MCIDs in symptomatic PAD patients through a walking exercise intervention is to increase PWT and COT by up to 4 minutes, which corresponds to two work stages during the standardized progressive treadmill test.


2021 ◽  
pp. 1358863X2110603
Author(s):  
Alexander Waddell ◽  
Sally Seed ◽  
David R Broom ◽  
Gordon McGregor ◽  
Stefan T Birkett ◽  
...  

Intermittent claudication (IC) is a classic symptom of peripheral artery disease, with first line treatment being supervised exercise therapy (SET). Despite this, SET is frequently underutilised, and adherence is often poor. An alternative option are home-based exercise programmes (HBEP). Although HBEPs are well tolerated, to the authors’ knowledge, no research has assessed their safety. The aim of this review was to assess the safety of HBEPs in people living with IC. We performed an electronic search of the MEDLINE, CINAHL, and Cochrane Library databases. The main parameter of interest was complication rate, calculated as the number of related adverse events per patient-hours. Subanalysis was undertaken to determine differences in safety for studies that did and did not include pre-exercise cardiac screening, and for studies with exercise at low, moderate, and high levels of claudication pain. Our search strategy identified 8693 results, of which 27 studies were included for full review. Studies included 1642 participants completing 147,810 patient-hours of home-based exercise. Four related adverse events were reported, three of which were cardiac in origin, giving an all-cause complication rate of one event per 36,953 patient-hours. Three of these events occurred following exercise to high levels of claudication pain, and one occurred with pain-free exercise. All four events occurred in studies without cardiac screening. Based on the low number of related adverse events, HBEPs appear to be a safe method of exercise prescription for people with IC. Our results strengthen the rationale for providing alternative exercise options for this population. PROSPERO Registration No.: CRD42021254581


VASA ◽  
2015 ◽  
Vol 44 (6) ◽  
pp. 405-417 ◽  
Author(s):  
Andrew W. Gardner

Abstract. Peripheral artery disease (PAD) is a significant medical concern that is highly prevalent, costly, and deadly. Additionally, patients with PAD have significant impairments in functional independence and health-related quality of life due to leg symptoms and ambulatory dysfunction. Exercise therapy is a primary treatment for patients with PAD, as ambulatory outcome measures improve following a program of exercise rehabilitation. This review describes the outcomes that improve with exercise, the potential mechanisms for improved leg symptoms, key exercise program considerations for training patients with PAD with walking-based exercise, other exercise modalities that have been utilised, the use of on-site supervised exercise programs, and a major focus on historical and contemporary trials on conducting home-based, minimally supervised exercise program to treat PAD. The review concludes with recommendations for future exercise trials, with particular emphasis on reported greater details of the exercise prescription to more accurately quantify the total exercise dose of the program.


JAMA ◽  
2015 ◽  
Vol 314 (18) ◽  
pp. 1936 ◽  
Author(s):  
Farzin Fakhry ◽  
Sandra Spronk ◽  
Lijckle van der Laan ◽  
Jan J. Wever ◽  
Joep A. W. Teijink ◽  
...  

2020 ◽  
pp. 019394592097747
Author(s):  
Mary O. Whipple ◽  
Erica N. Schorr ◽  
Kristine M.C. Talley ◽  
Julian Wolfson ◽  
Ruth Lindquist ◽  
...  

Nonresponse to exercise has been extensively examined in young athletes but is seldom reported in studies of aerobic exercise interventions in older adults. This study examined the prevalence of nonresponse and poor response to exercise in functional and quality of life outcomes and response patterns between and among older adults undergoing 12-weeks of supervised exercise therapy for the management of peripheral artery disease ( N = 44, mean age 72.3 years, 47.7% female). The prevalence of nonresponse (no change/decline in performance) in walking distance was 31.8%. The prevalence of poor response (lack of a clinically meaningful improvement) was 43.2%. Similar patterns of response were observed in both objective and patient-reported measures of physical function. All participants improved in at least one outcome; only two participants improved in all measured outcomes. Additional research should examine modifiable predictors of response to inform programming and maximize an individual’s potential benefit from exercise therapy.


Circulation ◽  
2012 ◽  
Vol 125 (1) ◽  
pp. 130-139 ◽  
Author(s):  
Timothy P. Murphy ◽  
Donald E. Cutlip ◽  
Judith G. Regensteiner ◽  
Emile R. Mohler ◽  
David J. Cohen ◽  
...  

2021 ◽  
Vol 128 (12) ◽  
pp. 1885-1912
Author(s):  
Joshua A. Beckman ◽  
Peter A. Schneider ◽  
Michael S. Conte

Effective revascularization of the patient with peripheral artery disease is about more than the procedure. The approach to the patient with symptom-limiting intermittent claudication or limb-threatening ischemia begins with understanding the population at risk and variation in clinical presentation. The urgency of revascularization varies significantly by presentation; from patients with intermittent claudication who should undergo structured exercise rehabilitation before revascularization (if needed) to those with acute limb ischemia, a medical emergency, who require revascularization within hours. Recent years have seen the rapid development of new tools including wires, catheters, drug-eluting technology, specialized balloons, and biomimetic stents. Open surgical bypass remains an important option for those with advanced disease. The strategy and techniques employed vary by clinical presentation, lesion location, and lesion severity. There is limited level 1 evidence to guide practice, but factors that determine technical success and anatomic durability are largely understood and incorporated into decision-making. Following revascularization, medical therapy to reduce adverse limb outcomes and a surveillance plan should be put in place. There are many hurdles to overcome to improve the efficacy of lower extremity revascularization, such as restenosis, calcification, microvascular disease, silent embolization, and tools for perfusion assessment. This review highlights the current state of revascularization in peripheral artery disease with an eye toward technologies at the cusp, which may significantly impact current practice.


Sign in / Sign up

Export Citation Format

Share Document