Feasibility of Breathwork Intervention With Older Adults After Knee Surgery

NCT07464860 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-06

No results posted yet for this study

Summary

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.

Conditions

  • Surgical Stress Response
  • Stress Physiological
  • Stress Physiology
  • Stress Psychological
  • Breathing Techniques
  • Breathing Exercises
  • Hypothalamic Pituitary Adrenal
  • Relaxation
  • Relaxation Therapy
  • Cortisol
  • Postoperative Pain
  • Postoperative Anxiety
  • Postoperative Depression
  • Quality of Recovery (QoR-15)

Interventions

BEHAVIORAL

A 5-minute Asynchronous Breathwork Intervention

Participants will be guided through the Box Breathing intervention with a pre-recorded YouTube video created by the PI. The video will be embedded into REDCap and delivered online asynchronously to provide flexibility and will be the same for all six sessions. The video will consist of a simple box pattern displayed on the screen with movement around the box that coincides with the PI's voiceover recording of the Box Breathing sequence. . Each session will be five minutes in length, with each section (e.g., inhalation, exhalation, breath retention) of the exercise lasting approximately four seconds. The sequence of each Box Breathing session is performed by breathing through the nose as follows: inhale for 4 seconds, hold the inhalation (lungs "full") for 4 seconds, exhale for 4 seconds, hold the exhalation (lungs "empty") for 4 seconds, and then return to inhaling for 4 seconds. Participants will be encouraged to exhale through the mouth if exhaling through the nose is not accessible.

BEHAVIORAL

A 5-minute Asynchronous Card Game Video

Participants will watch the TriPeaks video, a pre-recorded YouTube video created by the PI. The video will be embedded into REDCap and delivered online asynchronously to provide flexibility and will be the same for all six sessions. The video will consist of a screen recording of the PI playing the card game TriPeaks. Each session will be five minutes in length to match the Box Breathing intervention dosage and delivery.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Devon E Cobos Garcia, PhD Candidate · University of Arizona

  • Ruth E Taylor-Piliae, PhD · University of Arizona

  • Thaddeus W W Pace, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-10-06
Completion
2026-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07464860 on ClinicalTrials.gov