Passive Stretching in Peripheral Arterial Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Calf Plantar flexion, Dietary nitrate.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease, Walking, Difficulty, Inflammation. Basic parameters: 40 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease
Overview
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.
Interventions
- Device Calf Plantar flexion
Daily passive calf stretching - Dietary supplement Dietary nitrate
Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching
Primary outcome measures
- Functional capacity [Time frame: 12-14 weeks]
Secondary outcome measures (2)
- Inflammatory markers [Time frame: 12-14 weeks]
- Vascular function [Time frame: 12-14 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Wisconsin La Crosse — La Crosse
Identifiers
NCT: NCT06420752 · 232-JC-230.2