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OpenTrials
Completed

NCT Number: NCT06412991

Pedal Movement - Implementing Cycling as a Mobility Option

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Acute Care Surgery

Concord, North Carolina, 28025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cycle Therapy

Behavioral

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.

Primary outcomes

  1. Length of time to first Bowel Movement (BM)

    Time frame: Day 30

    Length of time to first Bowel Movement

  2. Length of time to first flatus

    Time frame: Day 30

    Length of time to first flatus

Secondary outcomes

  1. Rates of Venous thromboembolism (VTE)

    Time frame: Day 30

    VTE occurrence within 30 days post discharge

  2. Rates of pneumonia

    Time frame: Day 30

    Pneumonia occurrence within 30 days post discharge

  3. Hospital length of stay

    Time frame: Day 30

    Length of hospital stay

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 14, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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