An interventional study of Cycle Therapy in Ileus, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 76 is below the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
ambulation by surgical team
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.
Length of time to first Bowel Movement (BM)
Length of time to first Bowel Movement
Time frame: Day 30
Length of time to first flatus
Length of time to first flatus
Time frame: Day 30
Rates of Venous thromboembolism (VTE)
VTE occurrence within 30 days post discharge
Time frame: Day 30
Rates of pneumonia
Pneumonia occurrence within 30 days post discharge
Time frame: Day 30
Hospital length of stay
Length of hospital stay
Time frame: Day 30
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2024 to primary completion in Jan 2025, 4 months.
Of 40 non-industry interventional studies with no phase under Ileus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 53. This study's 4 months is below that.
Counting every sponsor, half of 40 studies reached it within 19 months; a quarter within 7 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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