scholarly journals Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial (Preprint)

2019 ◽  
Author(s):  
Katrin Paldán ◽  
Jan Simanovski ◽  
Greta Ullrich ◽  
Martin Steinmetz ◽  
Christos Rammos ◽  
...  

BACKGROUND Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients’ quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care. OBJECTIVE The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone–based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation. METHODS This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study group received usual care and the mobile intervention (trackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale. RESULTS The study enrolled 45 participants with symptomatic PAD (44% male). Of these participants, 21 (47%) were randomized to the study group and 24 (53%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]). CONCLUSIONS This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13651

2020 ◽  
Author(s):  
Katrin Paldán ◽  
Martin Steinmetz ◽  
Jan Simanovski ◽  
Christos Rammos ◽  
Greta Ullrich ◽  
...  

BACKGROUND Mobile interventions are intended to digitally nurse complex health care needs in chronic diseases, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training (SET) in patients with peripheral arterial disease (PAD). OBJECTIVE The aim of the present pilot study was to evaluate suitability, feasibility, and the impact on a prognosis relevant outcome measure for patients with PAD, the 6-minutes walking test, by using TrackPAD. METHODS Twenty-nine participants with symptomatic PAD were randomized. The study group (n=19) received usual care with additional use of TrackPAD. The control group (n=20) only received usual care. RESULTS The study group improved their 6-minutes walking distance, while the control group decreased their mean distance after 3 months of follow-up (83±72.2 vs. -38.8±53.7 m; p<0.01). The PAD-related quality of life improved significantly in terms of ‘symptom perception’ and ‘limitations in physical functioning’. Users’ feed-back showed increased motivation and a changed attitude to perform SET, while raising the educational background. CONCLUSIONS Besides the rating as a valued support tool by the user group, the mobile intervention TrackPAD was linked to an improvement in prognosis relevant outcome measure combined with an enhanced disease coping. CLINICALTRIAL International Registered Report Identifier (IRRID): DERR1-10.2196/13651


Vascular ◽  
2016 ◽  
Vol 25 (4) ◽  
pp. 412-422 ◽  
Author(s):  
Marko Novakovic ◽  
Borut Jug ◽  
Helena Lenasi

Increasing prevalence, high morbidity and mortality, and decreased health-related quality of life are hallmarks of peripheral arterial disease. About one-third of peripheral arterial disease patients have intermittent claudication with deleterious effects on everyday activities, such as walking. Exercise training improves peripheral arterial disease symptoms and is recommended as first line therapy for peripheral arterial disease. This review examines the effects of exercise training beyond improvements in walking distance, namely on vascular function, parameters of inflammation, activated hemostasis and oxidative stress, and quality of life. Exercise training not only increases walking distance and physiologic parameters in patients with peripheral arterial disease, but also improves the cardiovascular risk profile by helping patients achieve better control of hypertension, hyperglycemia, obesity and dyslipidemia, thus further reducing cardiovascular risk and the prevalence of coexistent atherosclerotic diseases. American guidelines suggest supervised exercise training, performed for a minimum of 30–45 min, at least three times per week, for at least 12 weeks. Walking is the most studied exercise modality and its efficacy in improving cardiovascular parameters in patients with peripheral arterial disease has been extensively proven. As studies have shown that supervised exercise training improves walking performance, cardiovascular parameters and quality of life in patients with peripheral arterial disease, it should be encouraged and more often prescribed.


VASA ◽  
2017 ◽  
Vol 46 (6) ◽  
pp. 462-470 ◽  
Author(s):  
Gerald Hackl ◽  
Andreas Prenner ◽  
Philipp Jud ◽  
Franz Hafner ◽  
Peter Rief ◽  
...  

Abstract. Background: Auricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established. Patients and methods: In this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36). Results: There were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128–236] meters to 345 [95 % CI 227–463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109–210] meters to 268 [95 % CI 182–366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls. Conclusions: Electroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.


Author(s):  
Susan Matthews ◽  
Martin Fox ◽  
Sarah Coy ◽  
Jane Whittaker ◽  
Gail Brough ◽  
...  

Background/Aims Peripheral arterial disease is common among those aged 60 years or above and can cause debilitating intermittent claudication. This impacts quality of life and is a marker for increased morbidity and mortality, mainly from cardiovascular disease. Access to recommended exercise programmes for people with symptomatic peripheral arterial disease is poor in most areas of the UK. This study aimed to evaluate the benefits of expanding an established cardiac rehabilitation service to accommodate supervised exercise for people with peripheral arterial disease Methods The study evaluated 11 participants peripheral arterial disease and intermittent claudication who were referred by the Manchester leg circulation service. Participants underwent the programme involving eight weekly 1.5 hour sessions of supervised exercise and cardiovascular education with support, reassurance and motivation. The participants' blood pressure, walking impairment, quality of life, anxiety and depression were monitored and reviewed. Results Overall, the participants' walking distance, intermittent claudication, quality of life and blood pressure had improved. The participants' overall satisfaction with the programme was excellent. The programme also demonstrated clinical and cost-effectiveness. Conclusions A structured, supervised exercise programme can have considerable benefits for people with peripheral arterial disease, improving their symptoms and quality of life. It may also help to reduce the morbidity and mortality risks associated with inactivity in this patient group.


2019 ◽  
Vol 316 (6) ◽  
pp. H1495-H1506 ◽  
Author(s):  
Ashley P. Akerman ◽  
Kate N. Thomas ◽  
Andre M. van Rij ◽  
E. Dianne Body ◽  
Mesfer Alfadhel ◽  
...  

Peripheral arterial disease (PAD) is characterized by lower limb atherosclerosis impairing blood supply and causing walking-induced leg pain or claudication. Adherence to traditional exercise training programs is poor due to these symptoms despite exercise being a mainstay of conservative treatment. Heat therapy improves many cardiovascular health outcomes, so this study tested if this was a viable alternative cardiovascular therapy for PAD patients. Volunteers with PAD were randomized to 12 wk of heat ( n = 11; mean age 76 ± 8 yr, BMI 28.7 ± 3.5 kg/m2, 4 females) or exercise ( n = 11; 74 ± 10 yr, 28.5 ± 6.8 kg/m2, 3 females). Heat involved spa bathing at ∼39°C, 3–5 days/wk for ≤30 min, followed by ≤30 min of callisthenics. Exercise involved ≤90 min of supervised walking and gym-based exercise, 1–2 days/wk. Following the interventions, total walking distance during a 6-min walk test increased (from ∼350 m) by 41 m (95% CI: [13, 69], P = 0.006) regardless of group, and pain-free walking distance increased (from ∼170 m) by 43 m ([22, 63], P < 0.001). Systolic blood pressure was reduced more following heat (−7 mmHg, [−4, −10], P < 0.001) than following exercise (−3 mmHg, [0, −6], P = 0.078), and diastolic and mean arterial pressure decreased by 4 mmHg in both groups ( P = 0.002). There were no significant changes in blood volume, ankle-brachial index, or measures of vascular health. There were no differences in the improvement in functional or blood pressure outcomes between heat and exercise in individuals with PAD. NEW & NOTEWORTHY Heat therapy via hot-water immersion and supervised exercise both improved walking distance and resting blood pressure in peripheral arterial disease (PAD) patients over 12 wk. Adherence to heat therapy was excellent, and the heat intervention was well tolerated. The results of the current study indicate that heat therapy can improve functional ability and has potential as an effective cardiovascular conditioning tool for individuals with PAD. Listen to this article's corresponding podcast at https://ajpheart.podbean.com/e/heat-therapy-vs-exercise-in-peripheral-arterial-disease/ .


Vascular ◽  
2020 ◽  
pp. 170853812094724
Author(s):  
Ufuk Turan Kursat Korkmaz ◽  
Ahmet Yuksel ◽  
Ayhan Cetinkaya ◽  
Yusuf Velioglu ◽  
Erhan Renan Ucaroglu ◽  
...  

Objective To examine dynamic thiol/disulphide homeostasis metrics as a novel risk factor of oxidative stress in patients with peripheral arterial disease. Methods One hundred patients with lower extremity peripheral arterial disease (a study group) and 100 control subjects were included in this prospective case–control study. Participants’ baseline clinical characteristics and laboratory data including some oxidant/antioxidant status parameters such as albumin, ferroxidase and myeloperoxidase, and thiol/disulphide homeostasis parameters such as native thiol, total thiol and disulphide, as well as native thiol/total thiol, disulphide/native thiol and disulphide/total thiol ratios were all recorded and then compared between the groups. Results Mean albumin and ferroxidase, and median myeloperoxidase levels were found to be significantly higher in patients with the peripheral arterial disease than in control group ( p = 0.045, p = 0.000 and p = 0.000, respectively). Mean native thiol and total thiol, and median disulphide levels were found to be significantly lower in the study group as compared with the control group ( p = 0.000, p = 0.000 and p = 0.037, respectively). According to the results of logistic regression analysis, systolic blood pressure, ferroxidase and myeloperoxidase levels were detected to be the independent predictors of peripheral arterial disease. Conclusion Our report is the first one in the literature investigating dynamic thiol/disulphide homeostasis metrics as a novel risk factor of oxidative stress in peripheral arterial disease. Dynamic thiol/disulphide homeostasis metrics may be used as a valuable risk factor of oxidative stress in patients with the peripheral arterial disease since it is readily available, easily calculated and relatively cheap.


10.2196/15669 ◽  
2020 ◽  
Vol 4 (8) ◽  
pp. e15669
Author(s):  
Julia Lortz ◽  
Jan Simanovski ◽  
Tabea Kuether ◽  
Ilonka Kreitschmann-Andermahr ◽  
Greta Ullrich ◽  
...  

Background The development of mobile interventions for noncommunicable diseases has increased in recent years. However, there is a dearth of apps for patients with peripheral arterial disease (PAD), who frequently have an impaired ability to walk. Objective Using a patient-centered approach for the development of mobile interventions, we aim to describe the needs and requirements of patients with PAD regarding the overall care situation and the use of mobile interventions to perform supervised exercise therapy (SET). Methods A questionnaire survey was conducted in addition to a clinical examination at the vascular outpatient clinic of the West-German Heart and Vascular Center of the University Clinic Essen in Germany. Patients with diagnosed PAD were asked to answer questions on sociodemographic characteristics, PAD-related need for support, satisfaction with their health care situation, smartphone and app use, and requirements for the design of mobile interventions to support SET. Results Overall, a need for better support of patients with diagnosed PAD was identified. In total, 59.2% (n=180) expressed their desire for more support for their disease. Patients (n=304) had a mean age of 67 years and half of them (n=157, 51.6%) were smartphone users. We noted an interest in smartphone-supported SET, even for people who did not currently use a smartphone. “Information,” “feedback,” “choosing goals,” and “interaction with physicians and therapists” were rated the most relevant components of a potential app. Conclusions A need for the support of patients with PAD was determined. This was particularly evident with regard to disease literacy and the performance of SET. Based on a detailed description of patient characteristics, proposals for the design of mobile interventions adapted to the needs and requirements of patients can be derived.


2009 ◽  
Vol 32 (5) ◽  
pp. 345 ◽  
Author(s):  
Katarzyna Skórkowska-Telichowska ◽  
Rajmund Adamiec ◽  
Dominika Tuchendler ◽  
Kazimierz Gąsiorowski

Purpose. To determine, in vitro, the susceptibility to apoptosis of lymphocytes from patients with peripheral arterial disease (PAD) in the presence of a low culture medium serum concentration, and to evaluate the correlation of the degree of apoptosis and the serum lipid levels. Methods. Lymphocytes were isolated from the venous blood of PAD patients with lower limb ischemia secondary to obliterative atherosclerosis of Fountain stage IIb. None of the patients had received hypo-lipemic therapy. The lymphocytes were incubated for 48 hr in media containing reduced concentrations of fetal calf serum. The study group consisted of 10 patients (7 men and 3 women), with a mean age of 67.0 ± 4.0 yr. The control group consisted of ten healthy volunteers, of the same mean age and sex proportion as the study group. Results. The percentage of non-apoptotic lymphocytes was lower (by 17%) and the percentage of late apoptotic lymphocytes was higher (by 33%) in the PAD patients than in the healthy donors when comparing the slopes of regression lines describing the relation between frequency of apoptotic lymphocytes in culture media containing reduced concentration of fetal calf serum The percentage of late apoptotic lymphocytes was correlated with the levels of total cholesterol (rs=0.93; P < 0.01) and LDL cholesterol (rs=0.80; P < 0.01) , and negatively correlated with the level of triglycerides (rs=-0.71; P < 0.05). Conclusion. The results of this study of lymphocyte apoptosis are important in understanding of the disease pathogenesis and should be taken into account in elaboration of treatment strategies.


2022 ◽  
Vol 12 ◽  
Author(s):  
Chih-Chin Hsu ◽  
Yu-Ting Lin ◽  
Tieh-Cheng Fu ◽  
Shu-Chun Huang ◽  
Cheng-Hsien Lin ◽  
...  

Peripheral arterial disease (PAD) results in insufficient flow to lower extremities. Aerobic exercise provides health benefits for individuals with PAD, but basic science behind it is still debated. Twenty-one PAD patients aged about 70 years with female/male as 7/14 were recruited. Among them, 11 were randomized to have supervised cycling training (SCT) and 10 to receive general healthcare (GHC) as controls. SCT participants completed 36 sessions of SCT at the first ventilation threshold within 12 weeks and the controls received GHC for 12 weeks. Ankle-brachial index (ABI), 6-min walk test (6MWT), peak oxygen consumption (V˙O2peak), minute ventilation (V˙E), minute carbon dioxide production (V˙CO2), erythrocyte rheology, including the maximal elongation index (EImax) and shear stress at 50% of maximal elongation (SS1/2), and the Short Form-36 (SF-36) questionnaire for quality of life (QoL) were assessed before and 12 weeks after initial visit. SCT significantly decreased the SS1/2 as well as SS1/2 to EImax ratio (SS1/2/EImax) and increased the erythrocyte osmolality in the hypertonic region as well as the area under EI-osmolality curve. The supervised exercise-induced improvement of erythrocyte deformability could contribute to the increased peripheral tissue O2 delivery and was possibly related with increased V˙O2peak. The physiological benefit was associated with significantly increased ABI, 6-min walking distance, cardiorespiratory fitness, and SF-36 score. However, no significant changes in aerobic capacity and erythrocyte rheological properties were observed after 12-week of GHC. In conclusion, SCT improves aerobic capacity by enhancing erythrocyte membrane deformability and consequently promotes QoL in PAD patients.


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