32 Participants NeededMy employer runs this trial

Breathwork for Postoperative Recovery After Knee Surgery

DE
Overseen ByDevon E Cobos Garcia, PhD Candidate, MS, BSN
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: University of Arizona
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population.

The body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.

Who Is on the Research Team?

TW

Thaddeus W W Pace, PhD

Principal Investigator

University of Arizona

DE

Devon E Cobos Garcia, PhD Candidate

Principal Investigator

University of Arizona

RE

Ruth E Taylor-Piliae, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults aged 65 or older who are scheduled for a knee replacement (not a revision), are in generally good health, do not have serious lung, heart, eye, seizure disorders, hormone issues affecting stress hormones, or severe psychiatric/cognitive problems. Participants must understand English.

Inclusion Criteria

I am scheduled for a first or second knee replacement within two months.
I do not have severe psychiatric or cognitive conditions requiring a power of attorney.
Able to understand written and verbal English
See 9 more

Exclusion Criteria

Do not have the technology requirements to complete data collection (no smartphone, tablet, laptop, or desktop computer; lack of reliable internet)
Do not have the technology requirements to complete data collection (no smartphone, tablet, laptop, or desktop computer; lack of reliable internet)
I had surgery complications that kept me in the hospital past the second day after surgery.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Total Knee Arthroplasty (TKA) followed by a Box Breathing intervention or TriPeaks Video session for two consecutive days

2 days
Postoperative Day 2 and 3

Follow-up

Participants are monitored for safety and effectiveness, including collection of saliva samples and completion of surveys on pain, anxiety, depression, and quality of recovery

4.5 months

What Are the Treatments Tested in This Trial?

Interventions

  • Breathwork Intervention (Box Breathing)

Trial Overview

The study compares two short video interventions after knee surgery: one teaches a breathing exercise called Box Breathing and the other shows an unrelated card game. The goal is to see if breathwork can help reduce stress and improve recovery in older adults.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group - Box Breathing InterventionExperimental Treatment1 Intervention
Group II: Attention Control Group - TriPeaks VideoActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+