Passive Stretching in Peripheral Arterial Disease Patients

Part of paid clinical trials in La Crosse, Wisconsin.

Sponsor
University of Wisconsin, La Crosse
Study ID
NCT06420752
Phase
PHASE2
Status
Recruiting
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Conditions

  • Inflammation
  • Peripheral Arterial Disease
  • Walking, Difficulty

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Calf Plantar flexion — DEVICE
    Daily passive calf stretching
  • Dietary nitrate — DIETARY_SUPPLEMENT
    Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching

Study Details

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.

Key Dates

Start date
May 20, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Functional capacity [ Time Frame: 12-14 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin La CrosseLa CrosseWisconsin54650
Jacob T Caldwell, Ph.D.
608-785-8684

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By research site
University of Wisconsin La Crosse· La Crosse, WI

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