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Completed

NCT Number: NCT04222751

Static Muscular Stretching for Treatment of PAD

Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40+
  • A resting ankle-brachial index (ABI) of 0.90 or less in either leg
  • Stable disease (PAD) for a minimum of 3-months

Exclusion criteria

  • Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
  • Cardiovascular rehabilitation program during the past 3 months
  • Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
  • Leg pain at rest
  • Cardiorespiratory disease
  • Diabetes
  • Major surgery or lower extremity revascularization during the previous 3 months
  • Major medical illness treatment during the prior 12 months
  • Central neurological disease
  • Limited ankle or knee joint range of motion
  • Requirement of oxygen with activity or exercise
  • More than a class II New York Heart Association level of heart failure
  • Wheelchair confinement, or inability to walk
  • Cognitive disorder
  • Vasculitis problem including Takayasu's arteritis, Buerger's disease, collagen disease or Raynaud's disease

Treatment and study plan

Ankle Splint

Device

Ankle splint will be slightly modified from the commercial form to include a pneumatic air cell secured under the forefoot below the splint's padded lining. This replaces the foam wedge provided by the manufacturer, allowing a gradual adjustment of the forefoot/toe region.

Primary outcomes

  1. Change in Muscle Oxygenation

    Time frame: 4 weeks

    Noninvasive assessment via NIRS monitor

  2. Change in Continuous Walking Distance

    Time frame: 4 weeks

    Assessed by 6-minute walking test

  3. Change in Total Walking Distance

    Time frame: 4 weeks

    Assessed by 6-minute walking test

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Mayo Clinic

Registry information

Official study title

Static Muscular Stretching for Treatment of Peripheral Artery Disease

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2020
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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