Pedal Movement - Implementing Cycling as a Mobility Option

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ileus
• Intervention / Treatment: Behavioral: Cycle Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mallory Royall, NP, DNP; Phone Number: 704.403.7070; Email: mallory.ragan@atriumhealth.org

Study Locations

• United States
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Northeast Acute Care Surgery
      • Contact: Mallory Royall, NP, DNP; Phone Number: 704-403-7070; Email: mallory.ragan@atriumhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cycle therapy; 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.	Behavioral: Cycle Therapy; 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.
No Intervention: ambulation as mobilization modality; ambulation by surgical team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of time to first Bowel Movement (BM)	Length of time to first Bowel Movement	Day 30
Length of time to first flatus	Length of time to first flatus	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Venous thromboembolism (VTE)	VTE occurrence within 30 days post discharge	Day 30
Rates of pneumonia	Pneumonia occurrence within 30 days post discharge	Day 30
Hospital length of stay	Length of hospital stay	Day 30

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Mallory Royall, NP, DNP, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: mobility; bowel function; bowel obstruction; cycle therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: IRB00111263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No