Passive Stretching in Peripheral Arterial Disease Patients

Phase 2

Recruiting

• Conditions: Peripheral Arterial Disease; Walking, Difficulty; Inflammation
• Interventions: Device: Calf Plantar flexion; Dietary Supplement: Dietary nitrate

• Registration Number: NCT06420752
• Lead Sponsor: University of Wisconsin, La Crosse

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study Start: 2024-05-20
• Study First Posted: 2024-05-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional Walking capacity	Calf Plantar flexion	Passive stretching of the calf muscles 5 days per week for 12-weeks
Functional Walking capacity	Dietary nitrate	Passive stretching of the calf muscles 5 days per week for 12-weeks
Inflammation	Dietary nitrate	Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation
Inflammation	Calf Plantar flexion	Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation

Primary Outcome Measures

Name	Time	Method
Functional capacity	12-14 weeks	6-minute walking distance will be assessed prior to an at various time points during the 12-week study

Secondary Outcome Measures

Name	Time	Method
Vascular function	12-14 weeks	Large vessel (flow-mediated vasodilation) and small vessel (Near-infrared spectroscopy on the calf) will be measured prior to and at various time points during the 12-week study.
Inflammatory markers	12-14 weeks	Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment.

Trial Locations

Locations (1)

University of Wisconsin La Crosse; 🇺🇸 La Crosse, Wisconsin, United States