Passive Stretching in Peripheral Arterial Disease Patients

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420752
• Other study ID #: 232-JC-230.2
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2024
• Source: University of Wisconsin, La Crosse
• Contact: Jacob T Caldwell, Ph.D.
• Phone: 608-785-8684
• Email: jcaldwell[@]uwlax.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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 alergy Crohn's Current smoker

Related Conditions & MeSH terms

• Inflammation
• Mobility Limitation
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Walking, Difficulty

Intervention

Device:
• Calf Plantar flexion
Daily passive calf stretching

Dietary Supplement:
• Dietary nitrate
Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching

Locations

Country	Name	City	State
United States	University of Wisconsin La Crosse	La Crosse	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, La Crosse

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity	6-minute walking distance will be assessed prior to an at various time points during the 12-week study	12-14 weeks
Secondary	Inflammatory markers	Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment.	12-14 weeks
Secondary	Vascular function	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.	12-14 weeks