## Protocol Section
### Identification Module
**NCT ID:** NCT06412991

**Brief Title:** Pedal Movement - Implementing Cycling as a Mobility Option

**Official Title:** Implementing Cycling as a Mobility Option for Operative and Non-operative Patients With Small Bowel Obstruction and Ileus Admitted by Northeast Acute Care Surgery at Atrium Health Cabarrus

#### Organization Study ID Info
**ID:** IRB00111263
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Cycling has been a proven exercise for decades as a low impact option to strengthen the lower body and improve cardiovascular health. There is also evidence that cycling helps to stimulate the contraction of the muscles in the intestine. Other outcomes frequently examined when considering benefits of ambulation include decreased rates of venous thromboembolic events, pneumonia, and decreased hospital length of stays. Therefore, there is added value to consider alternate mobility modalities.

**Detailed Description:** Ileus is a common post operative occurrence, one that not only causes patient discomfort but also contributes to considerable economic impact and can potentially progress to other serious complications. Historically ileus has been difficult to define. Review of the literature produces a general definition to include a varying time frame upon which a patient is not tolerating an oral diet, unable to pass flatus or stool, symptoms of nausea, vomiting, and sometimes abdominal pain. Small bowel obstruction, while different pathophysiology than ileus, presents similar manifestations. Often ileus and small bowel obstruction follow the same pathway aimed at attempted resolution with attempts at conservative management. Efforts to resolve ileus and nonoperative small bowel obstruction include bowel rest, nasogastric decompression, and encouraging mobility. Many studies support the practice of mobilization through ambulation as an effort to encourage return of bowel function. What is lacking in review of the literature however are other modalities to offer the patient in efforts to assist and encourage patients to mobilize outside of ambulation.

### Conditions Module

**Conditions:**

- Ileus

**Keywords:**

- bowel function

- bowel obstruction

- cycle therapy

- mobility

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Any patient admitted to the NorthEast Acute Care Surgery service on the Post Surgical Care 1 unit diagnosed with ileus, non-operative small bowel obstruction, or has had bowel surgery and with post operative small bowel obstruction and/or ileus.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patient will either ambulate a short distance to recumbent bike which will be stored on the postsurgical 1 unit or be assisted out of bed to use floor cycle bike. After the patient demonstrates individual competency with either cycle modality, the patient may participate in this activity with nursing staff but will not require Physical Therapy (PT) presence at the time of use. This will allow the patient to participate multiple times a day if they choose.

**Intervention Names:**

- Behavioral: Cycle Therapy

**Label:** Cycle therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** ambulation by surgical team

**Label:** ambulation as mobilization modality

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cycle therapy

**Description:** The patient will either ambulate a short distance to recumbent bike which will be stored on the postsurgical 1 unit or be assisted out of bed to use floor cycle bike.

**Name:** Cycle Therapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Length of time to first Bowel Movement

**Measure:** Length of time to first Bowel Movement (BM)

**Time Frame:** Day 30

**Description:** Length of time to first flatus

**Measure:** Length of time to first flatus

**Time Frame:** Day 30

#### Secondary Outcomes

**Description:** VTE occurrence within 30 days post discharge

**Measure:** Rates of Venous thromboembolism (VTE)

**Time Frame:** Day 30

**Description:** Pneumonia occurrence within 30 days post discharge

**Measure:** Rates of pneumonia

**Time Frame:** Day 30

**Description:** Length of hospital stay

**Measure:** Hospital length of stay

**Time Frame:** Day 30

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Admission to NorthEast Acute Care Surgery
* Admitted on Post Surgical Care 1 unit
* Diagnosis of small bowel obstruction
* Diagnosis of ileus
* Any patient that has had intestinal surgery
* Age 18-90

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Incarceration
* Non-English speaking

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mallory.ragan@atriumhealth.org

**Name:** Mallory Royall, NP, DNP

**Phone:** 704.403.7070

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Concord

**Contacts:**

***Contact 1:***

- **Email:** mallory.ragan@atriumhealth.org

- **Name:** Mallory Royall, NP, DNP

- **Phone:** 704-403-7070

- **Role:** CONTACT

**Country:** United States

**Facility:** Northeast Acute Care Surgery

**State:** North Carolina

**Zip:** 28025

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Mallory Royall, NP, DNP

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007415

- Term: Intestinal Obstruction

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M25585

- Name: Ileus

- Relevance: HIGH

- As Found: Ileus

- ID: M10449

- Name: Intestinal Obstruction

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000045823

- Term: Ileus

### Misc Info Module

- Version Holder: 2024-05-31
