Clinical trial NCT06412991: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileus
Keywords: bowel function
bowel obstruction
cycle therapy
mobility
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Length of time to first Bowel Movement (BM)
timeFrame: Day 30
measure: Length of time to first flatus
timeFrame: Day 30
Secondary outcomes:
measure: Rates of Venous thromboembolism (VTE)
timeFrame: Day 30
measure: Rates of pneumonia
timeFrame: Day 30
measure: Hospital length of stay
timeFrame: Day 30
Other outcomes:
Locations:
city: Concord
country: United States
facility: Northeast Acute Care Surgery
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mallory Royall, NP, DNP
role: PRINCIPAL_INVESTIGATOR
References: