## Protocol Section
### Identification Module
**NCT ID:** NCT06420752

**Brief Title:** Passive Stretching in Peripheral Arterial Disease Patients

**Official Title:** Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease

#### Organization Study ID Info
**ID:** 232-JC-230.2
#### Organization
**Class:** OTHER
**Full Name:** University of Wisconsin, La Crosse
### Status Module
#### Completion Date
**Date:** 2028-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Wisconsin, La Crosse

#### Responsible Party

**Investigator Affiliation:** University of Wisconsin, La Crosse

**Investigator Full Name:** Jacob Caldwell

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Peripheral Arterial Disease

- Walking, Difficulty

- Inflammation

**Keywords:**

- Cardiovascular

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Double blind placebo controlled.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 64

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Passive stretching of the calf muscles 5 days per week for 12-weeks

**Intervention Names:**

- Device: Calf Plantar flexion

- Dietary Supplement: Dietary nitrate

**Label:** Functional Walking capacity

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Blood and muscle biopsy samples pre/post passive stretching to assess local and systemic inflammation

**Intervention Names:**

- Device: Calf Plantar flexion

- Dietary Supplement: Dietary nitrate

**Label:** Inflammation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Functional Walking capacity

- Inflammation

**Description:** Daily passive calf stretching

**Name:** Calf Plantar flexion

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Functional Walking capacity

- Inflammation

**Description:** Weekday 140 ml dietary nitrate consumption two hours prior to passive stretching

**Name:** Dietary nitrate

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** 6-minute walking distance will be assessed prior to an at various time points during the 12-week study

**Measure:** Functional capacity

**Time Frame:** 12-14 weeks

#### Secondary Outcomes

**Description:** Blood and calf muscle biopsy will be used to assess various inflammatory markers pre/post treatment.

**Measure:** Inflammatory markers

**Time Frame:** 12-14 weeks

**Description:** 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.

**Measure:** Vascular function

**Time Frame:** 12-14 weeks

### Eligibility Module

**Eligibility Criteria:** 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 alergy Crohn's Current smoker

**Maximum Age:** 90 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jcaldwell@uwlax.edu

**Name:** Jacob T Caldwell, Ph.D.

**Phone:** 608-785-8684

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** La Crosse

**Contacts:**

***Contact 1:***

- **Name:** Jacob T Caldwell, Ph.D.

- **Phone:** 608-785-8684

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Wisconsin La Crosse

**State:** Wisconsin

**Status:** RECRUITING

**Zip:** 54650

#### Overall Officials

**Official 1:**

**Affiliation:** Assistant Professor

**Name:** Jacob T Caldwell, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Researchers.

**Description:** 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 NIA repository is the only current general repository for aging related work

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** 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.

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-05-06

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 265095

- Type Abbrev: Prot

- Upload Date: 2024-05-07T12:29

- Date: 2024-05-06

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 84459

- Type Abbrev: SAP

- Upload Date: 2024-05-07T12:30

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: HIGH

- As Found: Peripheral Arterial Disease

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: HIGH

- As Found: Peripheral Arterial Disease

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26689

- Name: Mobility Limitation

- Relevance: HIGH

- As Found: Walking, Difficulty

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000058729

- Term: Peripheral Arterial Disease

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000007249

- Term: Inflammation

- ID: D000051346

- Term: Mobility Limitation

### Misc Info Module

- Version Holder: 2024-05-31
