Inflammation, Peripheral Arterial Disease, Walking, Difficulty
Conditions
Keywords
Cardiovascular
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.
Interventions
DEVICECalf Plantar flexion
Daily passive calf stretching
DIETARY_SUPPLEMENTDietary nitrate
Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching
Sponsors
University of Wisconsin, La Crosse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind placebo controlled.
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers | 12-14 weeks | Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment. |
| 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. |
Countries
United States
Contacts
Primary ContactJacob T Caldwell, Ph.D.
Outcome results
None listed