Passive Stretching in Peripheral Arterial Disease Patients

University of Wisconsin, La Crosse

Status and phase: Enrolling; Phase 2

Conditions: Inflammation; Walking, Difficulty; Peripheral Arterial Disease

Treatments: Dietary Supplement: Dietary nitrate; Device: Calf Plantar flexion

Study type: Interventional

Funder types: Other

Identifiers

NCT06420752

232-JC-230.2

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Ankle-brachial index of 0.90 or less Stable condition for at least 3 months

Exclusion criteria

Habitual exercise or cardiovascular rehabilitation program during the past 3 months Critical limb ischemia, amputation, or leg pain at rest Major surgery or lower extremity revascularization in the last 3 months Heart Failure Kidney disease Beet allergy Crohn's Current smoker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Functional Walking capacity

Experimental group

Description:

Passive stretching of the calf muscles 5 days per week for 12-weeks

Treatment:

Device: Calf Plantar flexion

Dietary Supplement: Dietary nitrate

Inflammation

Experimental group

Description:

Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation

Treatment:

Device: Calf Plantar flexion

Dietary Supplement: Dietary nitrate