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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are:
Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.
Patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. Blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. Joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-weeks of passive calf stretching for 30 minutes 5 days a week | Experimental | A modified plantar fasciitis ankle splint will be used to passively stretch the calf muscle. |
|
| 4-weeks of no-stretching | No Intervention | No device will be used to stretch the calf muscle. Participants will go about their normal daily activity for 4-weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive calf muscle stretching device | Device | Modified night splints will be used to passive stretch the calf muscle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test distance | Submaximal exercise test used to assess aerobic capacity and endurance | 6-12 minutes |
| Muscle to tendon ratio | The ratio of gastrocnemius muscle fascicle length to Achilles' tendon length will be measured using ultrasound | 45 minutes |
| Endothelial function | Popliteal flow-mediated dilation will be measured as a index of macrovascular endothelial function in the leg. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David N Proctor, Ph.D. | Contact | 814-571-5234 | dnp3@psu.edu | |
| Jocelyn M Delgado, B.S. | Contact | 408-679-8390 | jmd956@psu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | Recruiting | University Park | Pennsylvania | 16802 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Participants will be randomized to 4-weeks of stretching or no stretching. Following the first 4-week intervention, participants will crossover and perform whichever intervention they did not receive previously.
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Due to the nature of the intervention, participants will not be blinded to stretching vs no-stretching interventions. The study team will be blinded to intervention order when performing data analysis.
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|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |