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A Box Breathing Intervention and the Surgical Stress Response in Older Adults Undergoing Total Knee Arthroplasty: A Randomized Controlled Feasibility Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• scheduled for elective TKA within the next week to two months (can be second knee, but cannot be a revision of the original knee)

• self-reported good health, including denial of debilitating illness that may affect participation in or be potentially exacerbated by deep, controlled breathing (i.e., chronic obstructive pulmonary disorder \[COPD\], symptomatic or advanced heart failure, complete heart block, glaucoma, epilepsy)

• denial of conditions that alter cortisol release or that require corticosteroid therapy (i.e., Cushing's syndrome, Addison's disease, pituitary tumors, adrenal gland tumors, asthma)

• denial of severe psychiatric or cognitive conditions that warrant the need for a durable power of attorney (DPOA)

• able to understand written and verbal English.

Locations
United States
Arizona
The University of Arizona
RECRUITING
Tucson
Contact Information
Primary
Devon E Cobos Garcia, PhD Candidate, MS, BSN
decg0131@arizona.edu
904-477-7960
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 32
Treatments
Experimental: Experimental Group - Box Breathing Intervention
Participants in this group will complete a 5-minute virtual Box Breathing session three times a day for two consecutive days following surgery on Postoperative Day 2 and 3. The Box Breathing intervention will be delivered asynchronously via a YouTube video created by the PI and accessed by participants via REDCap. Participants will also collect saliva samples three times per day (upon waking, 30 minutes after waking, and at bedtime) on Postoperative Day 2 and 3 to measure diurnal cortisol rhythm. Participants will fill out a 1-item survey about the Box Breathing session and a 1-item survey about saliva sample collection after each session and collection timepoint. Participants will also complete seven additional surveys regarding pain, anxiety, depression, and quality of recovery on the evening of Postoperative Day 3 after the final Box Breathing session.
Active_comparator: Attention Control Group - TriPeaks Video
Participants in this group will complete a 5-minute virtual TriPeaks Video session three times a day for two consecutive days following surgery on Postoperative Day 2 and 3. The TriPeaks Video will be delivered asynchronously via a YouTube video created by the PI and accessed by participants via REDCap. Participants will also collect saliva samples three times per day (upon waking, 30 minutes after waking, and at bedtime) on Postoperative Day 2 and 3 to measure diurnal cortisol rhythm. Participants will fill out a 1-item survey about the TriPeaks Video session and a 1-item survey about saliva sample collection after each session and collection timepoint. Participants will also complete seven additional surveys regarding pain, anxiety, depression, and quality of recovery on the evening of Postoperative Day 3 after the final TriPeaks Video session.
Related Therapeutic Areas
Sponsors
Leads: University of Arizona

This content was sourced from clinicaltrials.gov