Effectiveness of a Home-Based Exercise Program on Walking Ability in Patients with Peripheral Artery Disease—The HONOR Trial

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.

Download Full-text

Effectiveness of Home-Based Pain-Free Exercise versus Walking Advice in Patients with Peripheral Artery Disease: A Randomized Controlled Trial

Methods and Protocols ◽

10.3390/mps4020029 ◽

2021 ◽

Vol 4 (2) ◽

pp. 29

Author(s):

Fabio Manfredini ◽

Nicola Lamberti ◽

Luca Traina ◽

Gladiol Zenunaj ◽

Chiara Medini ◽

...

Keyword(s):

Peripheral Artery Disease ◽

Controlled Trial ◽

Ankle Brachial Index ◽

Exercise Program ◽

Walking Distance ◽

Control Group ◽

Peripheral Artery ◽

Free Exercise ◽

Home Based ◽

Artery Disease

Exercise therapy in the intermediate stages of peripheral artery disease (PAD) represents an effective solution to improve mobility and quality of life (QoL). Home-based programs, although less effective than supervised programs, have been found to be successful when conducted at high intensity by walking near maximal pain. In this randomized trial, we aim to compare a low-intensity, pain-free structured home-based exercise (SHB) program to an active control group that will be advised to walk according to guidelines. Sixty PAD patients aged > 60 years with claudication will be randomized with a 1:1 ratio to SHB or Control. Patients in the training group will be prescribed an interval walking program at controlled speed to be performed at home; the speed will be increased weekly. At baseline and after 6 months, the following outcomes will be collected: pain-free walking distance and 6-min walking distance (primary outcome), ankle-brachial index, QoL by the VascuQoL-6 questionnaire, foot temperature by thermal camera, 5-time sit-to-stand test, and long-term clinical outcomes including revascularization rate and mortality. The home-based pain-free exercise program may represent a sustainable and cost effective option for patients and health services. The trial has been approved by the CE-AVEC Ethics Committee (898/20). Registration details: Clinicaltrials.gov NCT04751890 [Registered: 12 February 2021].

Download Full-text

Don’t stop walking: an in-home rehabilitation program for peripheral artery disease patients during the COVID-19 pandemic.

10.21203/rs.3.rs-86871/v1 ◽

2020 ◽

Author(s):

Nicola Lamberti ◽

Sofia Straudi ◽

Roberto Manfredini ◽

Alfredo De Giorgi ◽

Vincenzo Gasbarro ◽

...

Keyword(s):

Peripheral Artery Disease ◽

Ankle Brachial Index ◽

Exercise Program ◽

Rehabilitation Program ◽

Walking Distance ◽

Walking Ability ◽

Peripheral Artery ◽

Walking Program ◽

External Conditions ◽

Artery Disease

Abstract Aims: We studied the outcomes of peripheral artery disease (PAD) patients enrolled in a structured in-home walking program before the lockdown due to the SARS-CoV-2 epidemic emergency, to determine whether this intervention ensured the maintenance of mobility in the case of strict movement restrictions.Methods: We considered 83 patients (age 72±11, males n=65) enrolled in a rehabilitation program based on two daily 8-minute sessions of slow intermittent in-home walking at a prescribed cadence with circa-monthly hospital visits. During the lockdown period, the program was updated by phone. The 6-minute (6MWD) and pain-free walking distance (PFWD) were measured pre- and postlockdown. Body weight (BW), blood pressure (BP), and the ankle-brachial index (ABI) were also determined.Results: Sixty-six patients were measured 117±23 days after their previous visit. A safe, pain-free execution the prescribed sessions, with a median distance covered of 74 km, was reported. Overall, the 6MWD was stable, while PFWD improved (p<0.001). Decreased BW with stable BP and ABI values were also recorded. When considering the outcome values according to the time of enrollment before the lockdown, new-entry subjects (≤3 months; n=35) obtained significant improvements, while those previously enrolled (>3 months; n= 31) were stable.Conclusion: In PAD patients, a structured exercise program easily performed in a home corridor and guided with phone assistance was adhered to by patients and showed effectiveness in maintaining mobility and risk factor control during the COVID-19 pandemic. Safe structured exercise may involve frail subjects regardless of walking ability, type of home and external conditions.

Download Full-text

Restless Leg Syndrome in Peripheral Artery Disease: Prevalence among Patients with Claudication and Benefits from Low-Intensity Exercise

Journal of Clinical Medicine ◽

10.3390/jcm8091403 ◽

2019 ◽

Vol 8 (9) ◽

pp. 1403

Author(s):

Lamberti ◽

López-Soto ◽

Rodríguez-Borrego ◽

Straudi ◽

Basaglia ◽

...

Keyword(s):

Peripheral Artery Disease ◽

Near Infrared ◽

Ankle Brachial Index ◽

Exercise Program ◽

Restless Leg Syndrome ◽

Peripheral Artery ◽

Low Intensity ◽

Home Based ◽

Artery Disease ◽

Low Intensity Exercise

Restless leg syndrome (RLS) disrupts sleep, affecting the quality of life of patients with various chronic diseases. We assessed the prevalence of RLS in peripheral artery disease (PAD) patients and the effects of a pain-free exercise program. A total of 286 patients with claudication were enrolled in a home-based low-intensity exercise program prescribed at the hospital. RLS was determined through standardized questions. Hemodynamics, degree of calf deoxygenation, and mobility were assessed using the ankle-brachial-index, a treadmill test assisted by near-infrared spectroscopy and the 6-min walk test, respectively. During hospital visits, persistence of RLS, adherence to exercise, hemodynamics, and mobility were assessed. At the enrollment, 101 patients (35%) presented RLS, with higher prevalence among females (p = 0.032). Compared to RLS-free patients, they showed similar hemodynamics but more severe calf deoxygenation (p < 0.001) and lower mobility (p = 0.040). Eighty-seven RLS patients (83%) reported the disappearance of symptoms after 39 (36−70) days of exercise. This subgroup, compared to nonresponders, showed higher adherence (p < 0.001), hemodynamic (p = 0.041), and mobility improvements (p = 0.003). RLS symptoms were frequent in PAD but were reduced by a pain-free walking exercise aimed at inducing peripheral aerobic adaptations. The concomitant recovery of sleep and mobility may represent a synergistic action against the cardiovascular risk in PAD.

Download Full-text

Exercise rehabilitation for peripheral artery disease: An exercise physiology perspective with special emphasis on the emerging trend of home-based exercise

VASA ◽

10.1024/0301-1526/a000464 ◽

2015 ◽

Vol 44 (6) ◽

pp. 405-417 ◽

Cited By ~ 14

Author(s):

Andrew W. Gardner

Keyword(s):

Peripheral Artery Disease ◽

Exercise Physiology ◽

Exercise Program ◽

Functional Independence ◽

Primary Treatment ◽

Peripheral Artery ◽

Exercise Rehabilitation ◽

Supervised Exercise ◽

Home Based ◽

Artery Disease

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.

Download Full-text

A group-mediated, home-based physical activity intervention for patients with peripheral artery disease: effects on social and psychological function

Journal of Translational Medicine ◽

10.1186/1479-5876-12-29 ◽

2014 ◽

Vol 12 (1) ◽

pp. 29 ◽

Cited By ~ 14

Author(s):

W Rejeski ◽

Bonnie Spring ◽

Kathryn Domanchuk ◽

Huimin Tao ◽

Lu Tian ◽

...

Keyword(s):

Physical Activity ◽

Peripheral Artery Disease ◽

Physical Activity Intervention ◽

Psychological Function ◽

Peripheral Artery ◽

Home Based ◽

Artery Disease

Download Full-text

Effect of a Home-Based Exercise Intervention of Wearable Technology and Telephone Coaching on Walking Performance in Peripheral Artery Disease

JAMA ◽

10.1001/jama.2018.3275 ◽

2018 ◽

Vol 319 (16) ◽

pp. 1665 ◽

Cited By ~ 54

Author(s):

Mary M. McDermott ◽

Bonnie Spring ◽

Jeffrey S. Berger ◽

Diane Treat-Jacobson ◽

Michael S. Conte ◽

...

Keyword(s):

Peripheral Artery Disease ◽

Exercise Intervention ◽

Wearable Technology ◽

Peripheral Artery ◽

Home Based ◽

Walking Performance ◽

Artery Disease ◽

Telephone Coaching

Download Full-text

P1234SNF472 IMPROVES LIMB BLOOD PERFUSION AND WALKING ABILITY IN A PERIPHERAL ARTERY DISEASE VASCULAR CALCIFICATION RAT MODEL

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa144.p1234 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Firas Bassissi ◽

Miguel David Ferrer Reynes ◽

M Mar Pérez ◽

Joan Perelló ◽

Carolina Salcedo

Keyword(s):

Peripheral Artery Disease ◽

Vascular Calcification ◽

Rat Model ◽

Blood Perfusion ◽

Walking Distance ◽

Arterial Calcification ◽

Walking Ability ◽

Peripheral Artery ◽

Increased Risk ◽

Artery Disease

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< 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<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.

Download Full-text