Static Muscular Stretching for Treatment of PAD

NCT04222751 | Completed FDA Device

• 1 other identifier: 19-005234 Mayo
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (3)

• Change in Muscle Oxygenation

  Noninvasive assessment via NIRS monitor

  4 weeks

• Change in Continuous Walking Distance

  Assessed by 6-minute walking test

  4 weeks

• Change in Total Walking Distance

  Assessed by 6-minute walking test

  4 weeks

Study Arms (2)

Stretch Group

EXPERIMENTAL

Subjects assigned to this group will be instructed on how to wear the device to produce the appropriate amount of dorsiflexion (stretch). Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.

Device: Ankle Splint

No Stretch Group

PLACEBO COMPARATOR

Subjects assigned to this group will wear the splints but instructed to wear the device in a position that produces no stretch. Splint devices will be worn at the assigned angle 5 days/week, 30 minutes/day, for 4 weeks. ABI, muscle oxygenation, and walking distance will be assessed pre/post stretching. Other health surveys will be administered.

Device: Ankle Splint

Interventions

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.

No Stretch Group; Stretch Group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• Mayo Clinic: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Judy Delp, PhD

  Florida State University, College of Medicine

  PRINCIPAL INVESTIGATOR

• Emily Pritchard, PhD

  Florida State University, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: July 29, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)