Early Mobilization for Heart Procedure Recovery

(ZEBRA Trial)

Recruiting at1 trial location

Overseen by Charles Henrikson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Oregon Health and Science University

Disqualifiers: Arterial access, BMI > 40, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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. The investigators want to find out if allowing patients to move around sooner after their procedure can improve their satisfaction and potentially lead to earlier discharge from the hospital. Type of Study: Clinical Trial Participant Population/Health Conditions: Patients aged 18-99 undergoing specific heart procedures such as atrial fibrillation treatment, atrial flutter treatment, supraventricular tachycardia treatment, diagnostic electrophysiology studies, AV node ablation, or Watchman device placement. Main Questions: Does early mobilization (getting up and moving around sooner) after the Z stitch procedure improve patient satisfaction? Participants will be divided into two groups, and researchers will compare those who have one hour of bedrest with those who have four hours of bedrest after the Z stitch procedure. The investigators want to see if the shorter bedrest period leads to higher patient satisfaction.

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 data supports the effectiveness of the treatment Early Mobilization for Heart Procedure Recovery?

Research shows that early mobilization after heart surgeries, like coronary artery bypass grafting, can improve physical function, such as walking distance, by the time patients leave the hospital. It also suggests that early mobilization can reduce complications and improve emotional recovery without long-term risks. ^{1 2 3 4 5}

Is early mobilization generally safe for humans after surgery?

Research shows that early mobilization after surgeries, like abdominal and heart procedures, is generally safe and can help with recovery. It may reduce complications and improve emotional well-being, although the best way to implement it can vary. ^{1 5 6 7 8}

How does the early mobilization treatment differ from other treatments for heart procedure recovery?

Early mobilization after heart procedures is unique because it encourages patients to start moving soon after surgery, which can lead to faster recovery and better long-term outcomes compared to traditional prolonged bed rest. This approach is based on evidence from other surgeries showing that early movement helps improve recovery and return to normal activities. ^{1 2 4 9 10}

Research Team

Charles Henrikson, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Early mobilization (Behavioural Intervention)

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.

Participant Groups

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+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. [2019]

2. Brazil pubmed.ncbi.nlm.nih.gov

Early Mobilization Prescription in Patients Undergoing Cardiac Surgery: Systematic Review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Early Mobilization on Physical Function in Patients after Cardiac Surgery: A Systematic Review and Meta-Analysis. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Early mobilization in the acute stage of myocardial infarction long term results]. [2008]

5. Japan pubmed.ncbi.nlm.nih.gov

[Fast-track cardiac anesthesia and perioperative management appropriate for early rehabilitation after coronary artery bypass graft (CABG) surgery]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Supervised Immediate Postoperative Mobilization After Elective Colorectal Surgery: A Feasibility Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pain and Opioid Consumption and Mobilization after Surgery: Post Hoc Analysis of Two Randomized Trials. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Early goal-directed mobilization in patients with acute type A aortic dissection: A randomized controlled trial. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Early ambulation and rehabilitation following heart surgery from the viewpoint of the cardiologist for adults]. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Orthopedic Principles to Facilitate Enhanced Recovery After Cardiac Surgery. [2021]