Static Muscular Stretching for Treatment of PAD

Peripheral Artery Disease Clinical Trial

Official title:

Static Muscular Stretching for Treatment of Peripheral Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04222751
• Other study ID #: 19-005234 Mayo
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Florida State University
• Contact: Albert Hakaim, MD
• Phone: 904-953-2077
• Email: hakaim.albert[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT04197609

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Muscle Oxygenation	Noninvasive assessment via NIRS monitor	4 weeks
Primary	Change in Continuous Walking Distance	Assessed by 6-minute walking test	4 weeks
Primary	Change in Total Walking Distance	Assessed by 6-minute walking test	4 weeks