NCT06420752

Passive Stretching in Peripheral Arterial Disease Patients

Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of Wisconsin, La Crosse · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Arterial Disease
• Walking, Difficulty
• Inflammation

Interventions

Type	Name	Description
DEVICE	Calf Plantar flexion	Daily passive calf stretching
DIETARY_SUPPLEMENT	Dietary nitrate	Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching

Timeline

• Start date: 2024-05-20
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2024-05-20
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study