Passive Stretching for Peripheral Arterial Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Wisconsin, La Crosse
Disqualifiers: Heart failure, Kidney disease, Crohn's, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Peripheral artery disease (PAD) leads to higher mortality rates and strains healthcare systems due to increased costs. It causes leg pain during walking due to reduced blood flow. Nitric oxide (NO) deficiency contributes to vascular issues in PAD, with few effective treatments available. Passive calf muscle stretching boosts NO levels, vascular health, and walking ability in PAD patients. However, the inflammatory processes underlying these improvements are unclear. This study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. Additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. The study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in PAD patients. This research is crucial for improving physical function and addressing exercise intolerance in PAD.
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 trial coordinators or your doctor.
What data supports the effectiveness of the treatment for Peripheral Arterial Disease?
Research shows that daily passive stretching of calf muscles can improve blood flow and walking ability in patients with peripheral arterial disease. Additionally, long-term passive stretching has been found to enhance vascular function and reduce arterial stiffness, which are important for cardiovascular health.
12345Is passive stretching safe for humans?
Research on passive stretching, often used in physical therapy, shows it is generally safe for humans, including older adults and those recovering from surgery, with no significant safety concerns reported in the studies.
35678How does passive stretching treatment for Peripheral Arterial Disease differ from other treatments?
Passive stretching is unique because it improves blood flow and reduces arterial stiffness by gently stretching muscles without active movement, which can enhance vascular function and flexibility. Unlike medications or surgical interventions, it is a non-invasive therapy that can be done regularly to improve circulation and muscle elasticity.
235910Eligibility Criteria
This trial is for individuals with Peripheral Arterial Disease (PAD), which causes leg pain and difficulty walking due to poor blood flow. Participants should be interested in exploring non-drug treatments like stretching and dietary changes to improve their condition.Inclusion Criteria
Ankle-brachial index of 0.90 or less
My health condition has been stable for at least 3 months.
Exclusion Criteria
Beet allergy
I have kidney disease.
I have Crohn's disease.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo passive stretching of the calf muscles 5 days per week for 12 weeks, combined with dietary nitrate to enhance walking capacity
12 weeks
5 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of functional capacity, inflammatory markers, and vascular function
2 weeks
Participant Groups
The study tests if passive calf muscle stretching, possibly combined with dietary nitrate supplements, can increase nitric oxide levels, reduce inflammation, and enhance walking ability in PAD patients over a period of 12 weeks.
2Treatment groups
Experimental Treatment
Group I: InflammationExperimental Treatment2 Interventions
Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation
Group II: Functional Walking capacityExperimental Treatment2 Interventions
Passive stretching of the calf muscles 5 days per week for 12-weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Wisconsin La CrosseLa Crosse, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, La CrosseLead Sponsor
References
Daily Passive Muscle Stretching Improves Flow-Mediated Dilation of Popliteal Artery and 6-minute Walk Test in Elderly Patients with Stable Symptomatic Peripheral Artery Disease. [2020]Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. In aged rats, we have shown that daily stretching of calf muscles improves endothelium-dependent dilation of arterioles from the soleus muscle and increases capillarity and muscle blood flow during exercise. Therefore, we hypothesized that daily muscle stretching of calf muscles would improve endothelium-dependent vasodilation of the popliteal artery and walking function in PAD patients.
Evidence for improved systemic and local vascular function after long-term passive static stretching training of the musculoskeletal system. [2021]Vascular function and arterial stiffness are important markers of cardiovascular health and cardiovascular co-morbidity. Transitional phases of hypoemia and hypermia, with consequent fluctuations in shear rate, occuring during repetitive passive stretching adminstration (passive stretching training) may constitute an effective stimulus to induce an amelioration in vascular function, arterial stiffness and vascular remodelling by improving central and local blood flow control mechanisms. Vascular function, arterial stiffness and vascular remodelling were evaluated before and after 12 weeks of passive stretching training and after 6 weeks from training cessation, in the femoral, popliteal (treated with stretching), and brachial arteries (untreated) of both sides. After passive stretching training, vascular function and arterial remodelling improved, and arterial stiffness decreased in all the arteries, suggesting modifications of both central and local blood flow control mechanisms. Passive stretching-induced improvements related to central mechanisms seemed to have a short duration, as they returned to pre-training baseline within 6 weeks from training cessation, whereas those more related to a local mechanism persisted in the follow-up.
Change in Contralateral Muscle Blood Volume During Passive Unilateral Muscle Stretching Before and After Surgery. [2021]Passive muscle stretching is a common physical therapy for critically ill patients in the intensive care units. This study aimed to evaluate the effects of unilateral passive stretching of the gastrocnemius muscle (GM) before and after surgery on blood volume (BV) in the contralateral (non-stretched) GM in patients who are sedated after surgery.
Passive leg movement enhances interstitial VEGF protein, endothelial cell proliferation, and eNOS mRNA content in human skeletal muscle. [2020]The present study used passive limb movement as an experimental model to study the effect of increased blood flow and passive stretch, without enhanced metabolic demand, in young healthy male subjects. The model used was 90 min of passive movement of the leg leading to a 2.8-fold increase (P
Effects of an eight-week stretching program on the passive-elastic properties and function of the calf muscles of older women. [2022]Calf muscle stretching programs are used to increase dorsiflexion range of motion at the ankle, yet the effects of the stretching programs on the passive properties of aged calf muscles and on standing and ambulatory function have not been studied. This initial study examined the effects of an eight-week stretching program on the passive-elastic properties of the calf muscles of older women and on selected functional activities.
The acute effect of stretching on the passive stiffness of the human gastrocnemius muscle tendon unit. [2022]Passive stretching is commonly used to increase limb range of movement prior to athletic performance but it is unclear which component of the muscle-tendon unit (MTU) is affected by this procedure. Movement of the myotendinous junction (MTJ) of the gastrocnemius medialis muscle was measured by ultrasonography in eight male participants (20.5 +/- 0.9 years) during a standard stretch in which the ankle was passively dorsiflexed at 1 deg s(-1) from 0 deg (the foot at right angles to the tibia) to the participants' volitional end range of motion (ROM). Passive torque, muscle fascicle length and pennation angle were also measured. Standard stretch measurements were made before (pre-) and after (post-) five passive conditioning stretches. During each conditioning stretch the MTU was taken to the end ROM and held for 1 min. Pre-conditioning the extension of the MTU during stretch was taken up almost equally by muscle and tendon. Following conditioning, ROM increased by 4.6 +/- 1.5 deg (17%) and the passive stiffness of the MTU was reduced (between 20 and 25 deg) by 47% from 16.0 +/- 3.6 to 10.2 +/- 2.0 Nm deg(-1). Distal MTJ displacement (between 0 and 25 deg) increased from 0.92 +/- 0.06 to 1.16 +/- 0.05 cm, accounting for all the additional MTU elongation and indicating that there was no change in tendon properties. Muscle extension pre-conditioning was explicable by change in length and pennation angle of the fascicles but post-conditioning this was not the case suggesting that at least part of the change in muscle with conditioning stretches was due to altered properties of connective tissue.
Do practical durations of stretching alter muscle strength? A dose-response study. [2009]To examine the time course (immediate, 10, 20, and 30 min) for the acute effects of 2, 4, and 8 min of passive stretching (PS) on isometric peak torque (PT), percent voluntary activation (%VA), EMG amplitude, peak twitch torque (PTT), rate of twitch torque development (RTD), and range of motion (ROM) of the plantarflexors.
The effect of prolonged static and cyclic stretching on ankle joint stiffness, torque relaxation, and gait in people with stroke. [2016]Continuous passive motion (cyclic stretching applied to the subject's limb) has been used for the rehabilitation of some orthopedic impairments; however, few researchers have considered its application in the management of neurological disorders such as stroke. The purpose of this study was to examine the short-term effects of prolonged static and cyclic calf stretching on passive ankle joint stiffness, torque relaxation, and gait in people with ischemic stroke.
Acute effect of passive one-legged intermittent static stretching on regional blood flow in young men. [2021]Passive stretching reduces stiffness in the lower limb arteries of the stretched limb. To address this physiological mechanism, we measured the change in shear rate in the posterior tibial artery during a single bout of one-legged passive calf stretching compared with that in the non-stretched leg.
[Changes in blood flow after longitudinal stretching of the cat m. gastrocnemius]. [2014]Longitudinal stretch of the cat m. gastrocnemius by 10-30% of initial length increased the passive strength and regularly decreased the blood flow, the latter being dependent not on the degree of deformation but on the value of passive tension. Postelongation hyperemia develops after the stretch. This reaction seems to be similar to hyperemia due to the artery occlusion in the muscle and is considerably weaker than the postcontraction increase in the blood flow. The character of intramuscular mechanical effects on the vessels during both the active contractions and the passive stretch, is discussed.