Recruiting
Phase 2

Passive Stretching

Sponsor:

University of Wisconsin, La Crosse

Code:

NCT06420752

Conditions

Peripheral Arterial Disease

Walking, Difficulty

Inflammation

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Calf Plantar flexion

Dietary nitrate

Study Details

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.

Conditions

Peripheral Arterial Disease

Walking, Difficulty

Inflammation

Study ID

NCT06420752

Start date

May 20, 2024

Status verified date

Mar, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Functional Walking capacity

Passive stretching of the calf muscles 5 days per week for 12-weeks

experimental: Inflammation

Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation

Interventions

Calf Plantar flexion

Daily passive calf stretching

Dietary nitrate

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

Primary outcome measure

  • Functional capacity [ Time Frame: 12-14 weeks ]

Central Contacts and Locations

Central contacts

Jacob T Caldwell, Ph.D.

608-785-8684jcaldwell@uwlax.edu

Locations

University of Wisconsin La Crosse

Recruiting

La Crosse, Wisconsin, United States, 54650

Contacts

Jacob T Caldwell, Ph.D.

608-785-8684

More Information

Sponsor

University of Wisconsin, La Crosse

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Keywords

  • Cardiovascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, La Crosse on 2025-04-02.