Early Mobilization for Heart Procedure Recovery

(ZEBRA Trial)

Recruiting at 1 trial location

Overseen By Charles Henrikson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Arterial access, BMI > 40, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4.5 hours

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early movement after certain heart procedures can improve patient satisfaction and potentially lead to faster hospital discharge. It specifically examines the effects of early mobilization (encouraging movement soon after surgery) following a Z stitch procedure. Participants will be divided into two groups: one with one hour of bedrest and another with four hours. Individuals who have undergone a heart procedure, such as atrial fibrillation treatment or Watchman device placement, and wish to assist researchers in understanding recovery times may find this trial suitable. As an unphased trial, this study offers participants the chance to contribute to valuable research that can enhance recovery protocols for future patients.

Will I have to stop taking my current medications?

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 early mobilization after the Z stitch procedure is safe?

Research has shown that getting patients moving soon after surgeries, including heart procedures, is generally safe and often aids recovery. For example, studies have found that early movement can reduce complications. However, specific data on the safety of early movement after using a Z stitch in heart procedures is not yet available.

In studies comparing different bedrest durations after procedures, early movement has been well-tolerated. Patients who start moving sooner usually do not experience more complications than those who remain in bed longer. This suggests that early movement is likely safe for patients after a Z stitch procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early mobilization for heart procedure recovery because it challenges the traditional approach of extended bedrest. Unlike the standard practice of keeping patients on bedrest for several hours, this method gets patients moving just one hour after their procedure. This could potentially speed up recovery times and shorten hospital stays. By allowing early movement, the approach aims to enhance circulation and reduce complications, offering a promising alternative for quicker, safer recovery.

What evidence suggests that early mobilization is effective for heart procedure recovery?

Research has shown that getting patients moving sooner after heart procedures can be very beneficial. People who start moving earlier often feel better and may leave the hospital sooner. In this trial, participants will join one of two groups: one group will have one hour of bedrest, while the other will have four hours. The ZEBRA study, which examined early movement after a specific heart procedure, found that patients were more satisfied when they didn't have to stay in bed as long. Early movement can lead to faster recovery and a more pleasant hospital stay. This approach emphasizes patient comfort and efficient recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Charles Henrikson, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-99 who are undergoing heart procedures like atrial fibrillation/flutter treatment, supraventricular tachycardia treatment, or getting a Watchman device. It's not for those who can't consent, have certain types of arterial access, need large sheaths (>16Fr) for their procedure, have a BMI over 40, or are having lead-extraction.

Inclusion Criteria

I am going to the EP lab for an atrial flutter procedure.

I am scheduled for a diagnostic heart rhythm test in the EP lab.

I am scheduled for a procedure to manage my heart's rhythm.

Exclusion Criteria

My BMI is over 40.

I am scheduled for or have had a lead extraction procedure.

You have a medical device that requires a large sheath for access.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo the Z stitch procedure with either 1 hour or 4 hours of bed rest, followed by ambulation and Z stitch removal

4.5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 30-day phone follow-up to evaluate longer-term outcomes

30 days

1 phone follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Early mobilization

Trial Overview

The study tests if early mobilization (moving around sooner) after the Z stitch procedure leads to better patient satisfaction and possibly earlier hospital discharge. Participants will be randomly assigned to either one hour or four hours of bedrest post-procedure to compare outcomes.

How Is the Trial Designed?

Group I: 1 hour bedrest Experimental Treatment 1 Intervention

One hour of bedrest, elevate head of bed to 30 degrees at 30 minutes, ambulate at 60 minutes, Z stitches out at 4 hours, eligible for discharge (if appropriate) at 4.5 hours.

Group II: 4 hour bedrest Active Control 1 Intervention

Four hours of bedrest, elevate head of bed to 30 degrees at 2 hours, Z stitches out at 4 hours, ambulate at 4 hours, eligible for discharge at 4.5 hours.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

A controlled study at the Cantonal Hospital of Geneva followed patients 4 years after an acute myocardial infarction, confirming that early mobilization post-heart attack does not pose long-term risks.

The findings support the idea that early mobilization has significant benefits compared to prolonged bed rest, reinforcing its safety and efficacy in recovery after a heart attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early mobilization in the acute stage of myocardial infarction long term results]. Maeder, JP., Bloch, A.[2008]

Early mobilization, defined as physical activity within the first five days after cardiac surgery, significantly improved the distance walked during a six-minute walking test by an average of 54 meters at hospital discharge, based on a meta-analysis of six randomized controlled trials involving 391 patients.

The study indicates that starting early mobilization on postoperative days 1-2, often combined with respiratory exercises or psychoeducation, can enhance physical function in patients recovering from coronary artery bypass grafting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Early Mobilization on Physical Function in Patients after Cardiac Surgery: A Systematic Review and Meta-Analysis. Kanejima, Y., Shimogai, T., Kitamura, M., et al.[2021]

Enhanced recovery after surgery (ERAS) protocols emphasize the importance of early postoperative mobilization for faster recovery and better long-term outcomes in patients after open cardiac surgery.

Improved techniques for stabilizing the sternal osteotomy, based on orthopedic principles, may allow for earlier mobilization and rehabilitation, potentially leading to quicker recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopedic Principles to Facilitate Enhanced Recovery After Cardiac Surgery. Gerdisch, MW., Allen, KB., Naka, Y., et al.[2021]

A systematic review of 8 studies on early mobilization after abdominal and thoracic surgery found that while some studies showed benefits in terms of hospital stay duration and gastrointestinal function, overall evidence was inconsistent and of poor quality.

Despite the potential benefits of early mobilization, there is currently insufficient high-quality evidence to establish effective protocols that improve postoperative outcomes, highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. Castelino, T., Fiore, JF., Niculiseanu, P., et al.[2019]

A new approach to postoperative care after cardiac surgery emphasizes early mobilization starting within the first few days, allowing most patients to climb stairs by the end of the first week and begin group therapy by the second week.

While early mobilization is beneficial for most patients, it should be carefully managed for those with specific conditions like heart insufficiency or complex arrhythmias, ensuring safety during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early ambulation and rehabilitation following heart surgery from the viewpoint of the cardiologist for adults]. Gleichmann, U., Körfer, R., Mannebach, H., et al.[2017]

In a study of 673 patients recovering from abdominal surgery, those with lower pain scores (3 or lower) were able to mobilize significantly more (1.9 hours/day) compared to those with higher pain scores (6 or greater), who only mobilized for 1.2 hours/day, indicating that effective pain management is crucial for promoting mobility post-surgery.

Patients who mobilized less had a higher incidence of postoperative complications, with 6.0% of those in the lowest mobilization quartile experiencing complications, compared to 0% in the highest quartiles, suggesting that increased mobilization may lead to better recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and Opioid Consumption and Mobilization after Surgery: Post Hoc Analysis of Two Randomized Trials. Rivas, E., Cohen, B., Pu, X., et al.[2022]

A study involving 42 patients who underwent elective colorectal surgery demonstrated that supervised mobilization can be safely initiated as early as 30 minutes post-surgery, with 71% of patients achieving significant mobilization within the first few hours.

No serious adverse events were reported, indicating that early mobilization is feasible and safe, although some patients experienced delays due to pain, nausea, or other symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Immediate Postoperative Mobilization After Elective Colorectal Surgery: A Feasibility Study. Thörn, RW., Stepniewski, J., Hjelmqvist, H., et al.[2022]

In a study of 77 patients who underwent surgery for acute type A aortic dissection, early postoperative mobilization was found to be safe, with no serious adverse events reported during the intervention.

Patients who received early goal-directed mobilization showed significant improvements in functional status, muscle strength, and quality of life, along with shorter hospital stays compared to those who received usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early goal-directed mobilization in patients with acute type A aortic dissection: A randomized controlled trial. Lin, Y., Liang, T., Zhang, X., et al.[2023]

Early mobilization of patients in the ICU after cardiac surgery is beneficial, as shown by a systematic review of 14 randomized clinical trials, indicating positive impacts on recovery.

The mobilization protocols typically involve low-intensity exercises and are conducted within the first postoperative day, utilizing techniques like progressive mobilization and resistance exercises for 10 to 30 minutes, twice daily.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Mobilization Prescription in Patients Undergoing Cardiac Surgery: Systematic Review. Borges, MGB., Borges, DL., Ribeiro, MO., et al.[2022]

In a study of 140 patients undergoing CABG surgery, fast-track cardiac anesthesia allowed for early rehabilitation, with 82% of patients extubated within 3 hours after surgery, indicating a safe and effective approach to recovery.

The early rehabilitation protocol resulted in high percentages of patients achieving first oral intake (92%), rising from bed (78%), and walking (61%) on the first postoperative day, with no perioperative complications reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fast-track cardiac anesthesia and perioperative management appropriate for early rehabilitation after coronary artery bypass graft (CABG) surgery]. Watanabe, Y., Kosaka, M., Kusume, Y., et al.[2013]

Citations

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heartrhythmopen.com

heartrhythmopen.com/article/S2666-5018(24)00180-6/fulltext

ZEBRA study: The Z stitch Early Bed Rest Assessment study

This study primarily investigates whether early mobilization following Z-stitch placement in venous vascular access management during EP procedures enhances ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666501824001806

ZEBRA study: The Z stitch Early Bed Rest Assessment study

This study primarily investigates whether early mobilization following Z-stitch placement in venous vascular access management during EP procedures enhances ...

3.

withpower.com

withpower.com/trial/phase-syncope-9-2023-3c808

Early Mobilization for Heart Procedure Recovery

The goal of this study is to understand the effects of early mobilization after a Z stitch procedure in patients undergoing certain heart-related treatments ...

4.

researchgate.net

researchgate.net/publication/381272305_ZEBRA_study_The_Z_stitch_Early_Bed_Rest_Assessment_study

(PDF) ZEBRA study: the Z stitch Early Bed Rest ...

This study primarily investigates whether early mobilization following Z-stitch placement in venous vascular access management during EP procedures enhances ...

5.

trialx.com

trialx.com/clinical-trials/listings/231328/the-z-stitch-early-bed-rest-assessment-study/

The Z Stitch Early Bed Rest Assessment Study

The goal of this study is to understand the effects of early mobilization after a Z stitch procedure in patients undergoing certain heart- ...

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06087497/the-z-stitch-early-bed-rest-assessment-study

The Z Stitch Early Bed Rest Assessment Study

The goal of this study is to understand the effects of early mobilization after a Z stitch procedure in patients undergoing certain heart-