Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Peripheral artery disease (PAD) leads to higher mortality rates and strains healthcare systems due to increased costs. It causes leg pain during walking due to reduced blood flow. Nitric oxide (NO) deficiency contributes to vascular issues in PAD, with few effective treatments available. Passive calf muscle stretching boosts NO levels, vascular health, and walking ability in PAD patients. However, the inflammatory processes underlying these improvements are unclear. This study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. Additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. The study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in PAD patients. This research is crucial for improving physical function and addressing exercise intolerance in PAD.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional Walking capacity | Experimental | Passive stretching of the calf muscles 5 days per week for 12-weeks |
|
| Inflammation | Experimental | Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calf Plantar flexion | Device | Daily passive calf stretching |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity | 6-minute walking distance will be assessed prior to an at various time points during the 12-week study | 12-14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment. | 12-14 weeks |
| Vascular function | Large vessel (flow-mediated vasodilation) and small vessel (Near-infrared spectroscopy on the calf) will be measured prior to and at various time points during the 12-week study. |
Not provided
Inclusion Criteria:
Ankle-brachial index of 0.90 or less Stable condition for at least 3 months
Exclusion Criteria:
Habitual exercise or cardiovascular rehabilitation program during the past 3 months Critical limb ischemia, amputation, or leg pain at rest Major surgery or lower extremity revascularization in the last 3 months Heart Failure Kidney disease Beet allergy Crohn's Current smoker
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob T Caldwell, Ph.D. | Contact | 608-785-8684 | jcaldwell@uwlax.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacob T Caldwell, Ph.D. | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin La Crosse | Recruiting | La Crosse | Wisconsin | 54650 | United States |
The study datasets will be submitted to a generalist repository (Aging Research Bio Bank or similar). This allows for individual-level data submission from clinical studies. This study will not generate genomics data and will not submit to the database of Genotypes and Phenotypes. To our understanding, the National Institutes of Aging repository is the only current general repository for aging related work
Raw data will be available after two years post data collection to allow for publication and only available for one year after data collection is complete.
Researchers.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2024 | May 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2024 | May 7, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D051346 | Mobility Limitation |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Double blind placebo controlled.
| Dietary nitrate | Dietary Supplement | Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching |
|
| 12-14 weeks |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |