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NCT Number: NCT06420752

Passive Stretching in Peripheral Arterial Disease Patients

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.

Recruiting

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin La Crosse

La Crosse, Wisconsin, 54650, United States

Location status: Recruiting

Location contact

Jacob T Caldwell, Ph.D.

CONTACT

608-785-8684

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calf Plantar flexion

Device

Daily passive calf stretching

Dietary nitrate

Dietary Supplement

Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching

Primary outcomes

  1. Functional capacity

    Time frame: 12-14 weeks

    6-minute walking distance will be assessed prior to an at various time points during the 12-week study

Secondary outcomes

  1. Inflammatory markers

    Time frame: 12-14 weeks

    Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment.

  2. Vascular function

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob T Caldwell, Ph.D.

CONTACT

[email protected]

608-785-8684

Sponsors and collaborators

Lead sponsor

University of Wisconsin, La Crosse

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
May 20, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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