scholarly journals Use of a Smartphone Application versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults with Peripheral Artery Disease: A Pilot Randomized Trial (Preprint)

10.2196/30295 ◽  
2021 ◽  
Author(s):  
Tracie Collins ◽  
Mugur Geana ◽  
Kathryn Overton ◽  
Mary Benton ◽  
Liuqiang Lu ◽  
...  
2021 ◽  
Author(s):  
Tracie Collins ◽  
Mugur Geana ◽  
Kathryn Overton ◽  
Mary Benton ◽  
Liuqiang Lu ◽  
...  

BACKGROUND Walking therapy improves functional outcomes in peripheral artery disease (PAD). Less is known about the additive benefit of a dietary intervention. OBJECTIVE Our objective was to explore the efficacy of a smartphone application (App) versus motivational interviewing (MI) to increase walking distance and promote weight loss in overweight/obese adults with PAD. METHODS We conducted a 3-month, 2-arm randomized pilot study at the University of Kansas. Participants had a body mass index (BMI) > 27 kg/m2 and symptomatic PAD, defined by an ankle-brachial index (ABI) < 0.9. Patients were randomized into two groups: 1) MI, delivered through in-person and telephone counseling, or 2) App, a mobile smartphone application. Both interventions encouraged walking for exercise and and healthy dietary habits (increasing fruits and vegetables as well as whole grains while reducing fat and sugary drinks). We assessed medical history at baseline. At baseline and 3 months, participants completed a BMI assessment, 6-minute walking distance, dietary habits, quality of life, and exercise behaviors. The primary outcome was 3-month change in walking distance. Secondary outcomes were changes in BMI, and quality of life. RESULTS We randomized 29 participants with a mean age of 66.03 (SD 8.12) years. At baseline, mean walking distance was 283.48 meters (SD 70.18) and 320.66 meters (SD 70.46) for MI and App participants, respectively. At three months, the mean walking distance was 333.77 meters (SD 50.63) and 323.16 meters (SD 55.06) for MI and App participants, respectively (p-value = 0.05, adjusting for baseline). At baseline, mean body weight was 248.87 lbs. (SD 55.78) and 226.74 lbs. (SD 61.86) for MI and App participants, respectively. At three months, mean body weight was 233.83 (SD 48.27) and 225.18 (SD 62.46) for MI and App, respectively (p < 0.01, adjusting for baseline). CONCLUSIONS Our study demonstrates that MI can promote weight loss in overweight/obese adults with PAD. There was no statistically significant increase in walking distance with the use of MI or a smartphone App in overweight/obese adults with PAD. Future large-scale studies are needcd to determine the efficacy of MI to promote weight loss in overweight or obese adults with PAD. CLINICALTRIAL The clinical trial registration for this study is NCT03694652 (https://clinicaltrials.gov/).


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.


2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Kerry S Russell ◽  
Denise Yates ◽  
Andrea Feller ◽  
Tianke Wang ◽  
Ping Chen ◽  
...  

Background: Peripheral artery disease (PAD) affects 8.5 million people in the US. PAD patients are at high risk for cardiovascular events, and their quality of life is often significantly impaired by decreased mobility. Interleukin-1β (IL-1β) may play an important role in this disease by promoting inflammatory responses that drive atherosclerotic plaque progression and impair vascular function. We sought to test whether interruption of IL-1β signaling would improve patient mobility and decrease plaque progression in the lower extremities. Methods: 38 patients (mean age 65; 71% male) with symptomatic PAD (confirmed by ankle-brachial index) were randomized 1:1 to receive Canakinumab (150 mg subcutaneously) or placebo monthly for up to 12 months. Plaque volume in the superficial femoral artery (SFA) was assessed serially using 3.0T MRI. Mobility was assessed serially using the 6-minute walk test (maximum and pain-free walking distance). Results: Canakinumab was safe and well-tolerated. 12 patients discontinued (8 placebo, 4 Canakinumab). MRI data (from 31 patients at 3 months; 21 patients at 12 months) showed no evidence of plaque progression in the SFA at either time point in placebo-treated patients; nor was there a change in plaque volume in the Canakinumab-treated group. There was a serial and significant improvement in placebo-adjusted maximum and pain-free walking distance observed as early as 3 months after treatment with Canakinumab (58-meter improvement over placebo in pain-free distance at 3 months, P=0.01). Two placebo-treated patients required peripheral vascular interventions due to progression of disease; however, no Canakinumab-treated patients required revascularization during the study. Canakinumab decreased markers of systemic inflammation (IL-6 and hsCRP). Conclusions: Treatment with Canakinumab may improve maximum and pain-free walk distance in patients with symptomatic PAD. In conjunction with results soon to be reported for the CANTOS trial of Canakinumab for secondary prevention of cardiovascular events, additional studies may provide support that inhibition of IL-1β signaling can improve symptoms and function in this patient population with high unmet need.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Firas Bassissi ◽  
Miguel David Ferrer Reynes ◽  
M Mar Pérez ◽  
Joan Perelló ◽  
Carolina Salcedo

Abstract Background and Aims Peripheral Artery disease (PAD) is a common vascular disease associated with functional impairment and increased risk of cardiovascular events in End Stage Kidney Disease (ESKD) patients undergoing dialysis. Poor limb salvage outcomes and high post-amputation mortality in hemodialysis (HD) patients highlight the need for earlier medical therapies. Cilostazol and pentoxifylline are approved for PAD. Their use in HD patients stays limited and cilostazol use requires caution in this population. Clinical studies demonstrate associations between arterial calcification and adverse outcomes in PAD patients. SNF472, a selective calcification inhibitor that interferes in the formation and growth of hydroxyapatite, is in Phase 3 for calciphylaxis treatment. This study aims to evaluate the effects of SNF472 on limb functional recovery and blood perfusion in a Vitamin D3 (VitD)-induced arterial calcification rat model. Method Arterial calcification was induced in 32 Sprague Dawley rats by 3 consecutive daily s.c. doses of 120 kIU/kg VitD. Rats were divided into four groups and treated during 12 days by: placebo s.c, placebo p.o, SNF472 (20 mg/kg/day, s.c.) or cilostazol (20 mg/kg/day, p.o.). An additional group of 8 rats without VitD received vehicle only (sham). Efficacy was evaluated at day 12 and 17 (5 days after treatment stop). Posterior limb blood perfusion was measured using Laser Doppler Imaging and limb walking ability was evaluated by measuring Maximum Walking Distance (MWD) and Maximum Walking Time (MWT) using a treadmill. Rats were sacrificed at day 26 (14 days after treatment stop), and aortas were collected for calcium analysis. Results VitD-induced arterial calcification was associated with decreased blood perfusion and impairment of limb walking ability (MWT and MWD) compared to sham. SNF472 reduced aorta calcification by 41% compared to placebo. No effects of cilostazol on vascular calcification were observed. The inhibition of calcification in SNF472-treated animals was associated with significant higher limb blood perfusion compared to placebo or Cilostazol (1.28 and 1.37-fold higher, respectively at day 12: p&lt; 0.001) and it was translated into a significant improvement in walking ability compared to placebo (515±114 meters vs 334±187 meters, respectively: p&lt;0.05). Conclusion SNF472 shows improvements in vascular calcification, blood perfusion and a functional parameter like walking distance in a PAD vascular calcification rat model. These results suggest that SNF472 may represent a new therapeutic approach for the treatment of PAD associated with high vascular calcification such as in renal disease.


2016 ◽  
Vol 36 (suppl_1) ◽  
Author(s):  
Duy Ha ◽  
George Casale ◽  
Alicia Luis ◽  
Kevin Harkins ◽  
Reagan Huber ◽  
...  

Introduction: Patients with peripheral artery disease (PAD) develop myofiber degeneration and fibrosis in their ischemic lower extremities, along with limb dysfunction. Walking performance improves with revascularization and exercise therapy, but effects on the myopathy are unknown. We previously showed fibrosis progresses with PAD and positively correlates with expression of vascular transforming growth factor-beta 1 (TGF-β1), a cytokine that stimulates collagen deposition. Hypothesis: We hypothesize that revascularization (RVS) and supervised exercise therapy (EXE) improve limb function in association with improved TGF-β1 dependent fibrosis. Methods: Gastrocnemius biopsies were collected from PAD patients (Fontaine Stage II; N=56) at baseline and 6 months after RVS (N=20), EXE (N=19), or no intervention (CTL; N=17). TGF-β1 expression was measured as grey scale units (gsu) by quantitative fluorescence microscopy of paraffin-embedded gastrocnemius sections. Collagen abundance was measured as optical density by quantitative multi-spectral bright-field microscopy of Masson Trichrome stained paraffin sections. Six Minute Walking Distance (SMWD), in meters, and Peak Walking Time (PWT), in seconds, were determined at baseline and 6 months. Relationships among TGF-β1, collagen, and limb function were assessed. Results: TGF-β1 expression and collagen density increased in CTL and EXE but not RVS patients. SMWD and PWT increased among RVS patients. PWT but not SMWD increased among EXE patients. SMWD and PWT were unchanged among CTL patients. The data are summarized in Table 1. Conclusions: RVS and EXE improved walking performance of patients with PAD, but only RVS prevented progression of fibrosis in the gastrocnemius of these patients. Over the same 6-month period, fibrosis increased in CTL muscle but was not sufficient to alter walking performance. The data suggest that benefits to the PAD leg may be greater with RVS compared to EXE.


2017 ◽  
Vol 37 (suppl_1) ◽  
Author(s):  
Constance J Mietus ◽  
Peter Karvelis ◽  
Timothy Lackner ◽  
Hernan Hernandez ◽  
Holly DeSpiegelaere ◽  
...  

Background: The myopathy of Peripheral Artery Disease (PAD), a consequence of ischemia caused by atherosclerotic plaques in arteries supplying the legs, is characterized by myofiber degeneration and fibrosis of the vascular walls and extramyofiber matrix. In association with fibrosis we have found a robust expression of the profibrotic cytokine TGFβ1 in vascular smooth muscle cells. Additionally, we have observed microvascular endothelial “swelling” in PAD muscle. Published data indicate that inhibitors of the angiotensin system reduce fibrosis in multiple organ systems and improve walking performance, in diverse patient populations. We hypothesize that “swelling” of microvasculature endothelial cells represents abnormal accumulation of basement membrane Collagen Type IV (Col-IV) and that treatment with Ramipril will improve the microvasculature. Methods and Results: Gastrocnemius biopsies of PAD patients at Fontaine Stage II (N=5) before and after six months of Ramipril intervention and control patients (N=4) were labeled with an antibody specific for Col-IV. Images were acquired with an automated wide-field microscope and then processed with Image Pro Plus® and AutoQuant® deconvolution software. We used Col IV label to measure wall thickness and lumen diameter of 230 to 360 microvessels per patient, with a custom MatLab program based on the Expectation Maximization algorithm coupled with a Gaussian Mixture Model. Microvessel wall thickness was significantly greater (p < 0.04) in PAD patients before (1.54 ± 0.04 μ) and after (1.61 ± 0.06 μ) Ramipril treatment compared to control (1.42 ± 0.02). Lumen diameter was significantly greater (p < 0.02) in Post-Ramipril (3.49 ± 0.04 μ) compared to Pre-Ramipril (3.18 ± 0.08 μ) and control (3.00 ± 0.11 μ) patients. Conclusions: The increase of microvessel lumen diameter with Ramipril treatment is expected to increase microvascular perfusion and thereby improve walking distance. Our study will be expanded to increase cohort size and evaluate the association of microvascular measurements with microperfusion determined by Contrast Enhanced Ultrasonography and with walking performance.


2020 ◽  
Vol 25 (4) ◽  
pp. 354-363
Author(s):  
Pierre Jéhannin ◽  
Meghan Craughwell ◽  
Loukman Omarjee ◽  
Alan Donnelly ◽  
Vincent Jaquinandi ◽  
...  

Lower extremity peripheral artery disease (PAD) induces an ischemic pain in the lower limbs and leads to walking impairment. Electrical stimulation has been used in patients with PAD, but no systematic review has been proposed to address the efficacy of the technique as a treatment for walking impairment in PAD. A systematic search was performed to identify trials focused on electrical stimulation for the treatment of walking impairment in patients with PAD in the Cochrane Central Register, PubMed, Embase, and the Web of Science. Studies were included where the primary outcomes were pain-free walking distance and/or maximal walking distance. When appropriate, eligible studies were independently assessed for quality using the Cochrane Collaboration’s tool for assessing risk of bias. Five studies eligible for inclusion were identified, of which only two were randomized controlled studies. Trial heterogeneity prevented the use of the GRADE system and the implementation of a meta-analysis. Three types of electrical stimulation have been used: neuromuscular electrical stimulation (NMES, n = 3), transcutaneous electrical stimulation ( n = 1), and functional electrical stimulation ( n = 1). The two available randomized controlled studies reported a significant improvement in maximal walking distance (+40 m/+34% and +39 m/+35%, respectively) following a program of NMES. Owing to the low number of eligible studies, small sample size, and the risk of bias, no clear clinical indication can be drawn regarding the efficacy of electrical stimulation for the management of impaired walking function in patients with PAD. Future high-quality studies are required to define objectively the effect of electrical stimulation on walking capacity.


2021 ◽  
Vol 10 (15) ◽  
pp. 3330
Author(s):  
Stefano Lanzi ◽  
Luca Calanca ◽  
André Berchtold ◽  
Lucia Mazzolai

This study aimed to investigate the relationship between supervised exercise training (SET)-induced changes in treadmill performance and 6 min walking distance, and changes in general (physical and mental) self-perceived health-related quality of life (HRQoL) in symptomatic patients with lower extremity peripheral artery disease (PAD). This is an observational study investigating Fontaine stage II PAD patients participating in 3-month SET. Before and following SET, treadmill performance (pain-free (PFWD) and maximal (MWD)), and 6 min walking distance (6MWD) were assessed. Self-perceived HRQoL was assessed with the Medical Outcomes Study Short-Form 36 (SF-36). Ankle- and toe-brachial indexes were also measured. One-hundred forty-seven patients with PAD were included (64.9 ± 9.6 y, 70% men). After SET, PFWD (+102%, p ≤ 0.001), MWD (+87%, p ≤ 0.001), and 6MWD (+14%, p ≤ 0.001) significantly increased. All eight SF-36 subscale scores significantly improved following SET (p ≤ 0.04). SET significantly improved physical and mental component summaries of the SF-36 (p ≤ 0.001). Larger increases in 6MWD were associated with greater improvements in physical (β = 0.19; p = 0.02) and mental (β = 0.24; p = 0.005) component summaries of the SF-36. No significant relationship was observed between changes in treadmill performance and changes in physical and mental component summaries of the SF-36. These results show that improvements in 6MWD following SET are related to improvements in general self-perceived HRQoL in patients with symptomatic lower extremity PAD. On the contrary, changes in treadmill performance were not related to improvements in HRQoL. These results suggest that the 6 min walking test is an essential outcome measure to assess overall patient functional status following interventions in patients with PAD.


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