Pedal Movement - Implementing Cycling as a Mobility Option

NCT06412991 | Completed

• 1 other identifier: IRB00111263
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileus

Keywords

bowel function; bowel obstruction; cycle therapy; mobility

Outcome Measures

Primary Outcomes (2)

• Length of time to first Bowel Movement (BM)

  Length of time to first Bowel Movement

  Day 30

• Length of time to first flatus

  Length of time to first flatus

  Day 30

Secondary Outcomes (3)

• Rates of Venous thromboembolism (VTE)

  Day 30

• Rates of pneumonia

  Day 30

• Hospital length of stay

  Day 30

Study Arms (2)

Cycle therapy

EXPERIMENTAL

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 as mobilization modality

NO INTERVENTION

ambulation by surgical team

Interventions

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.

Cycle therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18
• Pregnancy
• Incarceration
• Non-English speaking

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Northeast Acute Care Surgery

Concord, North Carolina, 28025, United States

Location

MeSH Terms

Conditions

Ileus; Intestinal Obstruction

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mallory Royall, NP, DNP

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: August 20, 2024
• Primary Completion: January 4, 2025
• Study Completion: February 3, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)