Pedal Movement - Implementing Cycling as a Mobility Option

NCT ID: NCT06412991

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2025-02-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ileus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Cycle Therapy

Intervention Type 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.

ambulation as mobilization modality

ambulation by surgical team

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mallory Royall, NP, DNP

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northeast Acute Care Surgery

Concord, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00111263

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.