Passive Stretching in Peripheral Arterial Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease Walking, Difficulty Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind placebo controlled.

Study Groups

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Functional Walking capacity

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

Group Type EXPERIMENTAL

Calf Plantar flexion

Intervention Type DEVICE

Daily passive calf stretching

Dietary nitrate

Intervention Type DIETARY_SUPPLEMENT

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

Inflammation

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

Group Type EXPERIMENTAL

Calf Plantar flexion

Intervention Type DEVICE

Daily passive calf stretching

Dietary nitrate

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Calf Plantar flexion

Daily passive calf stretching

Intervention Type DEVICE

Dietary nitrate

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No