Cycle Therapy for Intestinal Obstruction

Overseen By Mallory Royall, NP, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pregnancy, Incarceration, Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how using a recumbent bike or a floor cycle can benefit individuals with intestinal blockages or those who have undergone intestinal surgery. The research aims to determine if cycling can enhance intestinal muscle movement, potentially reducing complications such as blood clots, lung infections, and hospital stays. Participants are divided into two groups: one that walks as usual and another that engages in cycle therapy (exercise using a bike). Ideal participants are those recovering from intestinal surgery or experiencing small bowel obstruction or ileus (temporary paralysis of the intestine). As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cycle therapy is safe for patients with intestinal obstruction?

Research shows that cycling is a safe and easy activity for most people. Although specific evidence does not link cycling directly to treating intestinal blockage, it is a gentle exercise that usually doesn't stress the body. Cycling is often recommended to build muscle strength and improve heart health.

The study aims to determine whether cycling can aid muscle movements in the intestines. Reports have not indicated negative effects from cycling for this purpose. Since cycling is commonly used in various recovery programs, it is generally considered safe when done correctly.

For those considering joining a trial involving cycling, current research suggests it is a safe choice. Always consult healthcare professionals to ensure it suits individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cycle Therapy for intestinal obstruction because it introduces a new way to aid recovery through physical movement. Unlike standard care options such as bowel rest, IV fluids, and surgery, Cycle Therapy uses a recumbent or floor cycle bike to help patients get moving safely and comfortably right after surgery. This method allows patients to engage in gentle exercise multiple times a day without needing a physical therapist present, potentially speeding up recovery and improving overall outcomes.

What evidence suggests that cycle therapy is effective for intestinal obstruction?

Research has shown that cycling can help the intestines move more effectively, potentially shortening hospital stays and preventing issues like blood clots and pneumonia. In this trial, participants in the Cycle Therapy arm will use a recumbent or floor cycle bike to aid recovery from intestinal blockages. Although specific research on cycling for these blockages is limited, cycling is known to strengthen the lower body and improve heart health. These benefits suggest that cycling could be a helpful way to manage intestinal blockages. ^{1 2 6 7 8}

Who Is on the Research Team?

Mallory Royall, NP, DNP

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals with intestinal obstruction who are looking to improve their condition through exercise. Participants should be able to perform low-impact cycling and must not have any health issues that would limit their ability to safely engage in physical activity.

Inclusion Criteria

I have been diagnosed with a blockage in my small intestine.

I have been diagnosed with ileus.

Admission to NorthEast Acute Care Surgery

Exclusion Criteria

Pregnancy

Incarceration

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in cycle therapy or ambulation as a mobility modality to encourage bowel function

4 weeks

Daily participation encouraged

Follow-up

Participants are monitored for safety and effectiveness after treatment, including rates of VTE and pneumonia

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cycle Therapy

Trial Overview The study is testing the effectiveness of cycle therapy as a treatment option for patients with intestinal obstruction. It aims to see if cycling can help stimulate muscle contractions in the intestines, potentially reducing hospital stays and preventing complications like blood clots and pneumonia.

How Is the Trial Designed?

Group I: Cycle therapy Experimental Treatment 1 Intervention

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 II: ambulation as mobilization modality Active Control 1 Intervention

ambulation by surgical team

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. withpower.com withpower.com/trial/phase-ileus-6-2024-73994

Cycle Therapy for Intestinal Obstruction · Info for Participants It aims to see if cycling can help stimulate muscle contractions in the intestines, potentially reducing hospital stays and preventing complications like blood ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10040372/

Management of small bowel obstruction and systematic ... Evacuation of air and fluid from the small intestine improved outcomes so greatly, that gastrointestinal intubation was universally adopted as ...

3. clearpassage.com clearpassage.com/bowel-obstruction-treatment-success-rates/

Clear Passage | Bowel Obstruction Treatment Success Rates Results (shown here) were remarkable. The group we did not treat had 15 times more total bowel obstructions than those we treated. In fact, less ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05731947

Study Details | NCT05731947 | Evaluation of Revumenib in ... The study will be conducted in two parts. The Phase 1 portion of the study consists of a dose escalation cohort, and a signal-seeking expansion where ...

5. gastrojournal.org gastrojournal.org/article/S0016-5085%2823%2900149-X/fulltext

Randomized Placebo-Controlled Phase 3 Trial of Vibrating ... In conclusion, our study shows that the vibrating capsule produced significant improvements in bowel symptoms and QOL in patients with chronic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8647158/

Safety Findings in Pediatric Patients During Long‐Term ... Thirty‐five patients (39.3%) had AEs considered related to teduglutide treatment; abdominal pain and vomiting were most frequent (5.6% each).

7. jnm.snmjournals.org jnm.snmjournals.org/content/jnumed/early/2020/05/22/jnumed.120.242875.full.pdf

Risk of bowel obstruction in patients with mesenteric/ ... Moreover, PRRT was associated with a particularly high risk of abdominal complications such as bowel obstruction and ascites in patients with ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772572323002121

TOGA Therapeutic Oxygen for Gastrointestinal Atony In this first clinical report of therapeutic oxygen for gastrointestinal atony, the provision of 100% oxygen via nonrebreather mask is a useful therapy.