Static Muscular Stretching for Treatment of PAD

NCT ID: NCT04222751

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2025-06-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ankle Splint

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Ankle Splint

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Emily Pritchard

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judy Delp, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University, College of Medicine

Emily Pritchard, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University, College of Medicine

Locations

Mayo Clinic Florida

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

19-005234 Mayo

Identifier Type: -

Identifier Source: org_study_id

NCT04197609

Identifier Type: -

Identifier Source: nct_alias