Pedal Movement - Implementing Cycling as a Mobility Option

Ileus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412991
• Other study ID #: IRB00111263
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Wake Forest University Health Sciences
• Contact: Mallory Royall, NP, DNP
• Phone: 704.403.7070
• Email: mallory.ragan[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Ileus

Intervention

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.

Locations

Country	Name	City	State
United States	Northeast Acute Care Surgery	Concord	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time to first Bowel Movement (BM)	Length of time to first Bowel Movement	Day 30
Primary	Length of time to first flatus	Length of time to first flatus	Day 30
Secondary	Rates of Venous thromboembolism (VTE)	VTE occurrence within 30 days post discharge	Day 30
Secondary	Rates of pneumonia	Pneumonia occurrence within 30 days post discharge	Day 30
Secondary	Hospital length of stay	Length of hospital stay	Day 30