LEAP Therapy for Peripheral Artery Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Nebraska
Disqualifiers: Kidney disease, Type II diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to test the effects of leg exercise assistive paddling (LEAP) therapy during prolonged sitting (PS) on vascular and functional performance in those with peripheral artery disease (PAD) and age-matched controls. LEAP therapy is a novel application of passive limb movement to enhance blood flow through the legs without muscular contractions. Specifically, LEAP therapy is the rotational passive movement of the lower leg about the knee from 90 to 180 degrees of rotation at a cadence of 1Hz. Previous literature has indicated that this movement pattern can produce robust increases in blood flow in the passively moved limb in healthy individuals, and passive limb movement may protect vascular function during PS. However, the impact of LEAP therapy to improve blood flow in the legs of those with PAD during PS is unknown.
Participants will participate in a randomized cross-over design study with 2 visits (LEAP therapy and no LEAP therapy). For the first visit, participants will be randomly allocated to receive LEAP therapy during 2.5 hours of PS or not. For the second visit, participants will sit for 2.5 hours and will receive the condition that they did not previously receive. Before and after PS, the following measurements will be made: flow-mediated dilation of the popliteal and brachial arteries, arterial stiffness with tonometry techniques, microvascular vasodilatory capacity and skeletal muscle metabolic rate with near-infrared spectroscopy, autonomic nervous system function, and there will be blood drawn from the antecubital vein. After PS, participants will participate in a graded exercise test to assess functional walking capacity. Finally, during PS, near-infrared spectroscopy on the calf muscles and electrocardiogram will be collected continuously to monitor muscle oxygen availability and autonomic activity, respectively.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study coordinators or your doctor.
What data supports the effectiveness of the treatment LEAP Therapy for Peripheral Artery Disease?
Research shows that exercise therapy, like supervised walking, helps people with peripheral artery disease (PAD) walk longer distances, similar to surgical treatments. This suggests that exercise-based treatments, such as LEAP Therapy, could be effective for improving walking ability in PAD patients.
12345Is LEAP Therapy safe for humans?
There is no specific safety data available for LEAP Therapy, but a similar home-based leg heat therapy was found to be safe and well-tolerated in patients with peripheral artery disease.
12678How is LEAP Therapy different from other treatments for peripheral artery disease?
LEAP Therapy is unique because it involves Leg Exercise Assistive Paddling, which may offer a novel approach to improving walking ability in patients with peripheral artery disease, unlike traditional treatments like supervised walking exercise or surgical interventions.
1691011Eligibility Criteria
This trial is for individuals aged 50-85 with peripheral artery disease (PAD), specifically those who experience exercise-limiting claudication and have an ankle brachial index (ABI) ≤0.9. Women must be postmenopausal to participate. The study aims to include both PAD patients and age-matched controls.Inclusion Criteria
I do not have ulcers or dead tissue on my foot due to poor blood flow.
I am a postmenopausal woman (no periods for over 24 months).
PAD subjects must be able to provide written informed consent
+9 more
Exclusion Criteria
My doctor noted exercise limitations at my last check-up within a year.
I have difficulty walking due to a musculoskeletal injury.
My walking is limited due to reasons other than PAD.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo two sessions of prolonged sitting with and without LEAP therapy, each lasting 2.5 hours, with a minimum 7-day washout period between sessions.
2 weeks
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The LEAP therapy, which involves passive leg movements to boost blood flow without muscle contractions, is being tested against no therapy during prolonged sitting sessions of 2.5 hours. Participants will undergo two sessions in a randomized order: one with LEAP therapy and one without.
4Treatment groups
Experimental Treatment
Group I: PAD: No LEAP therapy, then LEAP therapyExperimental Treatment2 Interventions
Participants with peripheral artery disease will perform a bout of 2.5 hours of prolonged sitting without LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting with LEAP therapy.
Group II: PAD: LEAP therapy, then no LEAP therapyExperimental Treatment2 Interventions
Participants with peripheral artery disease will perform a bout of 2.5 hours of prolonged sitting with LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting without LEAP therapy.
Group III: Control: No LEAP therapy, then LEAP therapyExperimental Treatment2 Interventions
Participants will perform a bout of 2.5 hours of prolonged sitting without LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting with LEAP therapy.
Group IV: Control: LEAP therapy, then no LEAP therapyExperimental Treatment2 Interventions
Participants will perform a bout of 2.5 hours of prolonged sitting with LEAP therapy. After a minimum period of 7 days, they will then perform a bout of 2.5 hours of prolonged sitting without LEAP therapy.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Nebraska - OmahaOmaha, NE
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Who Is Running the Clinical Trial?
University of NebraskaLead Sponsor
References
Supervised walking exercise therapy improves gait biomechanics in patients with peripheral artery disease. [2021]In patients with peripheral artery disease (PAD), supervised exercise therapy is a first line of treatment because it increases maximum walking distances comparable with surgical revascularization therapy. Little is known regarding gait biomechanics after supervised exercise therapy. This study characterized the effects of supervised exercise therapy on gait biomechanics and walking distances in claudicating patients with PAD.
Patient education interventions to improve physical activity in patients with intermittent claudication: a protocol for a systematic mixed-studies review. [2022]Peripheral arterial disease (PAD) and intermittent claudication (IC) decrease an individual's capacity to engage in physical activity (PA) with potentially negative effects on PA behaviour. Strategies to improve PA among this population may provide a range of positive health benefits. We present a protocol to assess the components of patient education interventions that improve PA capacity and PA behaviour in patients with PAD and IC.
The effect of exercise on fitness and performance-based tests of function in intermittent claudication: a systematic review. [2022]Exercise is a widely accepted treatment known to improve walking ability in persons with peripheral arterial disease (PAD); however, it has not been confirmed as to whether exercise improves fitness and performance-based function and, consequently, performance of activities of daily living (ADL). This systematic review aims to identify whether any mode of structured exercise improves physical fitness or performance-based tests of function and whether improvement in walking ability is related to an improvement in these outcomes.
Use of a Smartphone App Versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults With Peripheral Artery Disease: Pilot Randomized Trial. [2023]Walking therapy improves functional outcomes in patients with peripheral artery disease (PAD). Less is known about the additive benefit of a dietary intervention.
Exercise Rehabilitation for Peripheral Artery Disease: A REVIEW. [2019]To summarize evidence regarding exercise therapy for people with lower extremity peripheral artery disease (PAD).
Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial. [2022]Supervised high-intensity walking exercise that induces ischemic leg symptoms is the first-line therapy for people with lower-extremity peripheral artery disease (PAD), but adherence is poor.
Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. [2023]Few noninvasive therapies currently exist to improve functional capacity in people with lower extremity peripheral artery disease (PAD). The goal of the present study was to test the hypothesis that unsupervised, home-based leg heat therapy (HT) using water-circulating trousers perfused with warm water would improve walking performance in patients with PAD. Patients with symptomatic PAD were randomized into either leg HT (n = 18) or a sham treatment (n = 16). Patients were provided with water-circulating trousers and a portable pump and were asked to apply the therapy daily (7 days/wk, 90 min/session) for 8 wk. The primary study outcome was the change from baseline in 6-min walk distance at 8-wk follow-up. Secondary outcomes included the claudication onset-time, peak walking time, peak pulmonary oxygen consumption and peak blood pressure during a graded treadmill test, resting blood pressure, the ankle-brachial index, postocclusive reactive hyperemia in the calf, cutaneous microvascular reactivity, and perceived quality of life. Of the 34 participants randomized, 29 completed the 8-wk follow-up. The change in 6-min walk distance at the 8-wk follow-up was significantly higher (P = 0.029) in the group exposed to HT than in the sham-treated group (Sham: median: -0.9; 25%, 75% percentiles: -5.8, 14.3; HT: median: 21.3; 25%, 75% percentiles: 10.1, 42.4, P = 0.029). There were no significant differences in secondary outcomes between the HT and sham group at 8-wk follow-up. The results of this pilot study indicate that unsupervised, home-based leg HT is safe, well-tolerated, and elicits a clinically meaningful improvement in walking tolerance in patients with symptomatic PAD.NEW & NOTEWORTHY This is the first sham-controlled trial to examine the effects of home-based leg heat therapy (HT) on walking performance in patients with peripheral artery disease (PAD). We demonstrate that unsupervised HT using water-circulating trousers is safe, well-tolerated, and elicits meaningful changes in walking ability in patients with symptomatic PAD. This home-based treatment option is practical, painless, and may be a feasible adjunctive therapy to counteract the decline in lower extremity physical function in patients with PAD.
Best medical treatment in patients with PAD. [2023]Background: Guidelines recommend comprehensive lifestyle change in patients with peripheral arterial disease (PAD) to prevent cardiovascular events and death. When compared with other populations, patients with PAD are less likely to receive best medical therapies (BMT). The aim of this pilot study was to integrate all aspects of BMT in an intervention program and to determine the feasibility of such an approach by highlighting strengths and obstacles of a multi-aspect intervention. Patients and methods: Patients consecutively hospitalized due to symptomatic PAD between 01 December 2021 and 28 February 2022 were included and followed for ten weeks. We randomized into a lifestyle intervention (education on BMT, a list of regional contact data for supervised exercise, weekly counselling by phone for ten times) vs. standard of care (one contact to talk about BMT). Vascular Quality of Life Questionnaire - 6 (VascuQoL-6) was used to collect patient reported outcomes. Results: Of 50 eligible patients 40 agreed to participate (32.5% female, 72.5 years in mean). During follow-up nine patients dropped out (4 in intervention group vs. 5). As for risk factor modification one patient was able to reach a normal weight body-mass-index (BMI) and nine reduced weight. Two patients stopped smoking, three reduced their consumption. The reported adherence to medication was a hundred percent. No patient attended supervised exercise therapy but eight trained at a home-based setting according to guidelines. The mean score of VascuQoL-6 at follow-up was higher in the intervention group compared to the control group (17.4 vs. 13.8 points) at last contact with both groups increasing from baseline. Conclusions: This pilot study followed 40 patients for up to 10 weeks after inpatient treatment while we randomized a multi-aspect lifestyle intervention versus standard of care. Thereby, the current study illustrated the numerous obstacles and provided pragmatic solutions for the planning of studies on BMT in this target population.
Critical limb ischaemia in a diabetic population from an Asian Centre: angiographic pattern of disease and 3-year limb salvage rate with percutaneous angioplasty as first line of treatment. [2021]Lower extremity amputation prevention (LEAP) is an ongoing program in our institution aimed at salvaging limbs in patients with critical limb ischemia (CLI). Patients in the LEAP program with reconstructible anatomy on initial Doppler imaging received either bypass surgery or percutaneous transluminal balloon angioplasty (PTA). We present the 3 year limb salvage rate and angiographic disease patterns in 42 consecutive diabetic patients with CLI who received PTA in 2005.
Angioplasty in critical limb ischaemia: one-year limb salvage results. [2020]Lower extremity amputation prevention (LEAP) is an ongoing programme in our institution aimed at limb salvage in patients with critical limb ischaemia (CLI). Patients in the LEAP programme with reconstructible anatomy on initial Doppler imaging received either bypass surgery or percutaneous transluminal balloon angioplasty (PTA). We describe the 1-year limb salvage rates in 46 consecutive patients with CLI who received PTA in 2005.
Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the integrated promoting action on research implementation in health services (i-PARIHS) framework. [2023]Peripheral artery disease (PAD) is a cardiovascular disease that limits patients' walking ability. Persistent ankle-foot orthosis (AFO) use may increase the distance patients can walk as well as physical activity.