Static Muscular Stretching for Treatment of PAD

Static Muscular Stretching for Treatment of Peripheral Artery Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Ankle Splint

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mauricia Buchanan, RN; Phone Number: 904-953-2077; Email: buchanan.mauricia@mayo.edu
• Study Contact Backup: Name: Albert Hakaim, MD; Phone Number: 904-953-2077; Email: hakaim.albert@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
      • Contact: Mauricia Buchanan, RN; Phone Number: 904-953-2077; Email: buchanan.mauricia@mayo.edu
      • Contact: Albert Hakaim, MD; Phone Number: 904-953-2077; Email: hakaim.albert@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stretch Group; 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; 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.
Placebo Comparator: No Stretch Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Judy Delp, PhD, Florida State University, College of Medicine; Principal Investigator: Emily Pritchard, PhD, Florida State University, College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 19-005234 Mayo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No