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NCT04197609 Clinical Trial

Static Muscular Stretching for Treatment of Peripheral Arterial Disease

Peripheral Artery Disease Clinical Trial

Official title:
Static Muscular Stretching for Treatment of Peripheral Arterial Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04197609
Other study ID # 19-005234
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date February 1, 2023

Study information
Verified date December 2019
Source Mayo Clinic
Contact Albert Hakaim, MD
Phone 904-953-2077
Email hakaim.albert@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are evaluating the effects of static muscle stretching on endothelial function, skeletal muscle oxygenation and walking function in patients with peripheral artery disease.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date February 1, 2023
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Resting ankle-brachial index (ABI) of 0.90 or less in either leg

- Stable disease minimum of 3 months

Exclusion Criteria:

- Habitual exercise

- Rehab program last 3 months

- Leg pain at rest

- Diabetes

- Revascularization surgery in past 3 months

- Require oxygen with activity or exercise

- Wheelchair confinement

- Limited ankle or knee joint range of motion

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dorsiflexion Splint
Ankle splint used to perform static muscle stretching

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Florida State University, College of Medicine

Outcome
Type Measure Description Time frame Safety issue
Primary Walking distance Improvement of 6 minute walk test. 4 weeks
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