Health TrialsbyHealthPanel

Passive Stretching in Peripheral Arterial Disease Patients

ConditionsPeripheral Arterial DiseaseWalking, DifficultyInflammation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-90
SponsorUniversity of Wisconsin, La Crosse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Calf Plantar flexion

    Device

    Daily passive calf stretching

  • Dietary nitrate

    Dietary supplement

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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Functional Walking capacityExperimental treatment 2 interventions
Group B: InflammationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Functional capacity

6-minute walking distance will be assessed prior to an at various time points during the 12-week study

Time frame
12-14 weeks

Secondary outcomes

1

Inflammatory markers

Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment.

Time frame
12-14 weeks
2

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.

Time frame
12-14 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, La Crosse

Lead sponsor

Source ClinicalTrials.gov
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